conference programme - isop2018geneva.org · jean-christophe delumeau (singapore) board members...

CONFERENCEPROGRAMME#ISoP2018 | www.isop2018geneva.org

Pharmacovigilance without borders

www.isop2018geneva.org2

VENUE FLOOR PLAN

Room 2 Plenary Hall

Room 4

Room 3

Registration

Cash Bar

Speaker Preview

Exhibition & Posters

Coffee Breaks

Main Entrance

Access to 1st Floor for Lunches

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CONTENTSWelcome Address 4

About ISoP 5

Committee 6

General Information 7

Conference Programme

Sunday 11 November 10

Monday 12 November 12

Tuesday 13 November 16

Wednesday 14 November 21

Poster Listing

Session 1 - Poster Presentation Monday 12 November 24

Session 2 - Poster Presentation Tuesday 13 November 39

Social Programme 53

Geneva - Amazing Experiences 54

Company Profiles 59

Exhibition Map 63

Supporters 64

Notes 65


WELCOME MESSAGEDear Colleagues,

On behalf of the ISoP Executive Committee and the Local Organizing Committee, it is our great pleasure to welcome you to the 18th Annual Meeting of the International Society of Pharmacovigilance (ISoP 2018), “Pharmacovigilance without borders”, in Geneva, Switzerland from the 11th to 14th November 2018.

Geneva is in the heart of Europe, strategically well positioned in these changing times. In this central and open environment we wish to continue discussing the importance of pharmacovigilance to health professionals, as well as to medicines regulatory agencies, scientific organisations, universities, state authorities and the pharmaceutical industry.

ISoP 2018 meeting will be an opportunity to take stock of current issues in pharmacovigilance, and for the first time, ISoP members have organised their own conference symposia. This will raise new ideas for discussion and also allow opportunity to return to some ongoing important issues.

Our aim is to optimise pharmacovigilance, so that it can operate without borders, offering us greater efficiency, clarity of reporting and thus enable us to analyse the latest information to better care for patients on a worldwide basis.

As you fly into Geneva it will be clear that you are on the shores of Europe’s largest lake and at the base of the Alps, only 45 minutes away from the highest peak in Europe. Geneva does not live in the shadow of its geographical surroundings. It strives to provide a strong multicultural balance, creating a city that offers a very good homeostasis of outdoor activities and cultural offerings.

Welcome to Geneva!

Sincerely,

Victoria Rollason Chair of the Local Organising Committee Co-chair of the Scientific Committee

Sten Olsson President of ISoP

Ian CK Wong Chair of the Scientific Committee

Mira Harrison-Woolrych Co-Chair of the Scientific Committee

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ABOUT ISoPINTERNATIONAL SOCIETY OF PHARMACOVIGILANCEISoP is a global professional, independent, not-for-profit society, open to anyone with an interest in the safe and effective use of medicinal products. ISoP aims to foster science, learning and research in pharmacovigilance in all countries.

These objectives are met by providing:> Collegial and convivial support among

fellow pharmacovigilance professionals> An open and impartial forum for sharing

experience, knowledge and solutions> A platform for discussion and generation

of new research and ideas> Meetings, education and

affordable training> Regional Chapters and Special

Interest Groups> Opportunities for networking

in a friendly environment

ISoP ADVISORY BOARD EXECUTIVE COMMITTEEPresident Sten Olsson (Sweden)

Vice President Ian C K Wong (UK and Hong Kong)

Secretary General Mira Harrison-Woolrych (New Zealand)

Treasurer Jean-Christophe Delumeau (Singapore)

BOARD MEMBERSHilda Ampadu (Ghana) Brian Edwards (UK) Deirdre McCarthy (USA)Jan Petracek (Czech Republic)Phil Tregunno (UK)Marco Tuccori (Italy)Hervé Le Louët (France, Past President)

ANNUAL MEETINGS (ESOP AND ISoP)*ESOP Annual Meetings1993 Geneva, Switzerland1994 Rouen, France1995 Cambridge, England1996 Lisbon, Portugal1997 Berlin, Germany1998 Budapest, Hungary1999 Ankara, Turkey2000 Verona, Italy

ISoP Annual Meetings2001 Carthage-Tunis, Tunisia2002 Amsterdam, The Netherlands2003 Marrakech, Morocco2004 Dublin, Ireland2005 Manila, Philippines2006 Liège, Belgium2007 Bournemouth, UK2008 Buenos Aires, Argentina2009 Reims, France2010 Accra, Ghana2011 Istanbul, Turkey2012 Cancun, Mexico2013 Pisa, Italy2014 Tianjin, China2015 Prague, Czech Republic2016 Agra, India2017 Liverpool, UK2018 Geneva, Switzerland 2019 Bogota, Colombia

* In 2000, the European Society of Pharmacovigilance (ESOP) became the International Society of Pharmacovigilance (ISoP).


COMMITTEESLOCAL ORGANISING COMMITTEEChairVictoria ROLLASON, University Hospitals of Geneva (Switzerland)

CommitteeMario Bertazzoli, Helsinn Healthcare Lugano (Switzerland)Marie Besson, University Hospitals of Geneva (Switzerland)Jules Desmeules, University Hospitals of Geneva (Switzerland)François Girardin, University Hospitals of Geneva (Switzerland)Roseline Ing Lorenzini, University Hospitals of Geneva (Switzerland)Christian Lovis, University Hospitals of Geneva (Switzerland)David Niedrig, University Children’s Hospital Zurich and drugsafety.ch (Switzerland)Frédérique Rodieux, University Hospitals of Geneva (Switzerland)Stefan Russmann, Klinik Hirslanden Zürich and drugsafety.ch (Switzerland)Caroline Samer, University Hospitals of Geneva (Switzerland)

SCIENTIFIC PROGRAMME COMMITTEEChairIan C K Wong, University of Hong Kong and UCL School of Pharmacy (UK)

Co-ChairsMira Harrison-Woolrych, (New Zealand)Victoria Rollason, University Hospitals of Geneva (Switzerland)

CommitteePia Caduff, Uppsala Monitoring Centre (Sweden)Bruce Donzanti, Genentech, Inc (USA)Noha Iessa, WHO (Switzerland)Ambrose Isah, University of Benin City (Nigeria)Richard Hill, Therapeutic Goods Administration (Australia)Gurumurthy Parthasarathi, JSS University Mysore (India)Mónica Tarapues, Central University of Ecuador (Ecuador)Lynn Zhou, Sanofi (China)

ORGANISERS

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GENERAL INFORMATIONVENUEInternational Conference Centre Geneva17, rue de Varembé CH-1202 Geneva Switzerland

From Geneva Central Station (Cornavin):> Bus 5: Departing from the Gare Cornavin

and getting off at the stop Vermont > Bus 8: Departing from the Gare Cornavin

and getting off at the stop UIT > Tram 15: Departing from the Gare Cornavin

and getting off at the stop Sismondi> On foot: Around 20 minutes

From the Airport:> Bus 5: Departing from the airport

and getting off at the stop Vermont > By taxi: Around 15 minutes

(depending on traffic)

ACCOMMODATIONFor help booking accommodation or if you have any queries about your hotel reservation, please visit the registration desk where one of the organisers will be able to assist you.

EXHIBITION, POSTERS AND COFFEE BREAKSThe exhibition will take place on the Ground Level, next to the Poster Area, right behind the registration area. Refreshments will be served at the following times:

CERTIFICATE OF ATTENDANCEA certificate of attendance will be provided for all attendees of the pre-conference training course and main conference by e-mail. Certificates will be emailed once the online survey has been completed. A link to the survey will be emailed to all attendees on the last day of the conference.

CLOAKROOMThere is a cloakroom located opposite the Registration Desk on the Ground Level of the CICG which is open during conference hours. It is unmanned. Any items deposited there are the responsibility of each individual – the organisers will not be responsible for any loss of personal items.

EMERGENCY PROCEDURESIn the event of an emergency at the CICG, please follow the instructions from the staff.

In the event of an evacuation of the Convention Centre, all delegates, exhibitors’ and organisers are requested to muster on the esplanade outside the CICG. This is necessary so that we can readily contact everyone to return to their building when the emergency is over. Delegates with access requirements will be guided to the nearest refuge point by venue staff, where they will receive further assistance. No one is to return to the building until official announcements have been made by the CICG.

Date Morning Afternoon

Monday 12 November 10:45 - 11:15 15:30 - 16:00

Tuesday 13 November 09:45 - 10:00 15:30 - 16:00

Wednesday 14 November 10:00 - 10:30 16:30 - 16:45


GENERAL INFORMATIONFIRST AIDIn the event of an accident or an emergency, contact a member of the organization at the registration. Please be as accurate and as concise as possible with any information you are providing, especially the exact location of the emergency.

INTERNET ACCESSComplimentary Wi-Fi is available for all attendees:

Network: ISOP2018Password: GENEVAThe complimentary Wi-Fi is intended for basic browsing only.

INSURANCEThe conference organising committee or its agents will not be responsible for any medical expenses, loss or accidents incurred during the conference. Delegates are strongly advised to arrange their own personal insurance to cover medical and other expenses including accident or loss. Where a delegate has to cancel for medical reasons, the normal cancellation policy will apply. It is recommended that citizens from EU countries bring with them a current EHIC card.

LOST AND FOUNDIf you have misplaced any personal items or found an item to hand in, please visit the registration desk located at the entrance of the conference venue.

MOBILE PHONESDelegates are kindly requested to keep their mobile phones on silent in all rooms where scientific and educational sessions are being held, as well as in and around the poster exhibition area.

NAME BADGEA name badge will be provided on arrival to the congress upon presentation of the relevant registration documents. The name badge must be worn at all times and is to be visible both inside the meeting rooms and sessions, as well as at all events organised during the meeting, including the supporting social programme.

REGISTRATION TIMESThe main registration desk will be open at the following times:

Date Opening Times

Sunday 11 November (training courses only) 08:00 - 18:30

Monday 12 November 07:30 - 17:30

Tuesday 13 November 07:30 - 17:30

Wednesday 14 November 07:30 - 16:30

GENEVA TOURISMGeneva Tourism will have an information stand accessible to all delegates for the duration of the conference. Do not hesitate to visit the stand for any information about Geneva.

SMOKING AND ELECTRIC CIGARETTESUnder Swiss law smoking and vaping are not permitted in enclosed public places and workplaces, including hotel bedrooms therefore, please use designated smoking areas.

SOCIAL MEDIAFollow @isoponline on twitter and get all latest updates. We encourage you to tweet your highlights during the conference using hashtag #ISoP2018.

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SPEAKER PREVIEW TIMESThe Speaker Preview room is located near the cash-bar on the Ground Level and is open at the following times:

Date Opening Times

Monday 12 November 07:30 - 17:30

Tuesday 13 November 07:30 - 17:30

Wednesday 14 November 07:30 - 16:30

USEFUL TELEPHONE NUMBERS118 for Fire Service

117 for Police

144 for Ambulance

SOCIAL PROGRAMMEPlease see page 53 for further details on the Social programme.


PRE-CONFERENCE PROGRAMME SUNDAY 11 NOVEMBER 2018

Pre-Conference Course 1 MorningPharmacovigilance In The Aging Population Room 3

Pre-Conference Course 2 MorningPharmacovigilance In Pre-Approval Phases Room 4

Elderly patients represent a special population that requires a special monitoring of drug safety. Polypharmacy, co-morbidities and the age-related deterioration of physiological functions may contribute to increase vulnerability to adverse drug reactions in this population.Chairs: Victoria Rollason, University Hospitals Geneva (Switzerland) / Marco Tuccori, University Hospital of Pisa (Italy)

Pharmacovigilance science has traditionally been a discipline focused on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to an evolution and maturing of drug safety and risk management throughout the lifecycle.In this one-day course, we will provide examples of drugs never approved for safety reasons, we will give practical examples of how collect safety information during the different phases of drug development and we will review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development.Chairs: Jan Petracek, PrimeVigilance (Czech Republic) / Bruce Donzanti, Genentech, Inc (USA)

08:30 – 09:00 Registration 08:30 – 09:00 Registration

09:00 – 10:00 Old Age Is No Place For SissiesPia Caduff, Uppsala Monitoring Centre (Sweden)

09:00 – 10:00 Drug Development Stopped For Safety Reasons In Pre-Approval Phases Mario Bertazzoli, Helsinn (Switzerland)

10:00 – 11:00 Drugs And Aging: Pharmacologist PerspectiveMarco Tuccori, University Hospital of Pisa (Italy)

10:00 – 11:00 Collecting Adverse Drug Reactions In Clinical TrialsJan Petracek, PrimeVigilance (Czech Republic)

11:00 – 11:30 Coffee Break

11:30 – 12:30 ADRs From Medication Error In The Elderly PopulationBrian Edwards, Chair Pharmaceutical Ergonomics & Human Factors Group (UK)

11:30 – 12:30 Development Safety Update ReportsJan Petracek, PrimeVigilance (Czech Republic)

12:30 – 13:30 Lunch Break

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Pre-Conference Course 1 Afternoon Pharmacovigilance In The Aging Population Room 3

Pre-Conference Course 2 Afternoon Pharmacovigilance In Pre-Approval Phases Room 4

13:30 – 14:10 Drug Safety In Elderly Patients: Role Of Co-Morbidities And PolypharmacyStefan Weiler, University Hospital of Zurich (Switzerland)

13:30 – 14:30 Pharmacovigilance Planning Jan Petracek, PrimeVigilance (Czech Republic)

14:10 – 14:50 Adverse Drug Reactions In The Elderly: Age-Based Signal Detection Laura Sottosanti, Italian Medicines Agency (Italy)

14:30 – 15:15 Approaches To Safety In Vulnerable Populations (Including Pregnancy, Children)Brian Edwards, Chair Pharmaceutical Ergonomics & Human Factors Group (UK)

14:50 – 15:30 Elderly Patients In Clinical Trials: Status Of The ArtGiovanni Furlan, Pfizer (Italy)

15:30 – 16:00 Coffee Break 15:15 – 15:45 Coffee Break

16:00 – 16:30 Tools To Assess Potentially Inappropriate Prescribing In The Elderly PopulationVictoria Rollason, University Hospitals Geneva (Switzerland)

15:45 – 16:30 Limits Of Safety Assessment In Clinical Trials: Ethnic, Social And Cultural FactorsBrian Edwards, Chair Pharmaceutical Ergonomics & Human Factors Group (UK)

16:30 – 17:30 QPPV Role And Future ChallengesLucía Castrillo Soto, Helsinn (Ireland)

16:30 – 17:30 Advancements In Pharmacovigilance Pre-Approval PhasesBruce Donzanti, Genentech, Inc (USA)

17:30 – 17:45 Wrap-up and Conclusions 17:30 – 17:45 Wrap-up and Conclusions

18:00 – 19:30 Welcome Reception


CONFERENCE PROGRAMME MONDAY 12 NOVEMBER 2018

08:00 – 09:00 Registration

09:00 – 09:30 Opening Ceremony Sten Olsson, President of ISoP; Ian CK Wong, Chair of the Scientific Committee; Mira Harrison-Woolrych, Co-chair of the Scientific Committee; Victoria Rollason, Chair of the Local Organising Committee

WHO-ISoP joint session: PV Coalition of Interested Partners 09:30 – 13:00 Room 2

09:30 – 10:45 Opening session / WHO-ISoP joint session WHO Coalition of Interested Partners (CIP) initiativeChair: Clive Ondari (WHO) Speakers: Viola Macolic (WHO) and Sten Olsson (ISoP)

10:45 - 11:15 Coffee Break & Poster Viewing

11:15 - 12:00 WHO-ISoP joint session (Continued) Integrating PV in disease programmes / Experience working with multi-stakeholders in HIV and TB Chairs: Viola Macolic (WHO) and Ian CK Wong (University of Hong Kong)

Current Status of PV in Botswana and Opportunities for System StrengtheningStephen Ghanie (Botswana Medicines Regulatory Authority)

Private sector collaboration with National regulatory systems 12:00 – 13:00 Room 2 for PV – Regional Updates

12:00 - 12:10 Africa and Middle East angle Esteban Herrero-Martinez (AbbVie, UK), on behalf of IFPMA

12:10 - 12:20 Latin America angle Bruce Donzanti (Genentech Inc., USA), on behalf of FIFARMA

12:20 - 12:30 Asia Pacific angle Jean-Christophe Delumeau (Bayer, Singapore), on behalf of EFPIA

12:30 - 12:40 Russia/CIS angle Jean-Christophe Delumeau (Bayer, Singapore), on behalf of EFPIA

12:40 - 13:00 Discussion / Q&A

13:00 - 14:00 Lunch Break

13:00 - 14:00 ISoP Chapter Networking Session Around A Lunch Level 1 Cafeteria

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Symposium 1 14:00 –15:30 Room 2 Symposium 2 14:00 –15:30 Room 3&4

Taking advantage of new data and technologies to facilitate the collection of safety data and to enhance their value for contributing to decision making Chair: Katherine Donegan (MHRA, UK)

The impact of adverse drug reactions on public health – how to get relevant and reliable data as the basis for preventive measures and the assessment of their success?Chair: Jürgen Beckmann (Germany)

14:00 – 14:20 Additional data sources for supplementing signal detection Sophie Reeve (MHRA, UK)

14:00 - 14:25 Measuring the Impact of Adverse Drug Reactions on Public Health – an Overview of the MethodologySuzanne McCarthy (School of Pharmacy, University College Cork, Ireland)

14:20 - 14:40 Promotion of Digitalized Pharmacovigilance Technologies towards Protection of Public HealthPhil Tregunno (MHRA, UK) / Amin Hussein Al Amiri (UAE Ministry of Health and Protection)

14:25 - 14:50 O-002 Opportunities and Pitfalls when Measuring Harm Reduction through Pharmacovigilance ActivitiesFlorence Van Hunsel (The Netherlands Pharmacovigilance Centre Lareb, Netherlands)

14:40 - 15:00 Harnessing the Power of Real-World Data for Safety SurveillanceJamie Geier (Pfizer, USA)

14:50 - 15:05 O-003 Serious Consequences from Medication Errors Identified in VigibaseAlem Zekarias (Uppsala Monitoring Centre, Uppsala, Sweden)

15:00 - 15:30 Q&A / Panel discussion 15:05 - 15:30 Discussion

15:30 – 16:00 Coffee Break & Poster Viewing


CONFERENCE PROGRAMME MONDAY 12 NOVEMBER 2018

Symposium 3 16:00 – 17:30 Room 2 Symposium 4 16:00 – 17:30 Room 3&4

Pavia And Proforma; Projects Increasing PV Readiness In Sub-Saharan Africa Chair: Linda Härmark (Pharmacovigilance Centre Lareb, Netherlands)

Teaching Pharmacovigilance To Undergraduates And Pharmacovigilance Beginners Chair: Eugene van Puijenbroek (Pharmacovigilance Centre Lareb, Netherlands)

16:00 - 16:20 O-005 PAVIA: Strengthening Pharmacovigilance in AfricaFrank Cobelens (Amsterdam Institute for Global Health & Development)Ambrose Isah (University of Benin/University of Benin Teaching Hospital, Nigeria)

16:00 - 16:05 IntroductionEugene van Puijenbroek (Pharmacovigilance Centre Lareb, Netherlands)

16:05 - 16:25 Methods For Undergraduate EducationJelle Tichelaar (VU University Medical Centre (VUmc), Netherlands)

16:20 - 16:40 O-004 The Proforma Project PresentationEleni Aklillu (Karolinska Institute, Sweden)

16:25 - 16:45 O-006 What Future Healthcare Professionals Need To Know About Pharmacovigilance. Development Of A PV Core Curriculum For University Teaching With Focus On Clinical AspectsRike van Eekeren (Pharmacovigilance Centre Lareb, Netherlands)

16:40 - 17:00 Results Baseline Assessment/PVRoad Map 1Sten Olsson (Karolinska Institute, Sweden)

16:45 - 17:00 O-007 Anywhere, Anytime – Distance Learning In PharmacovigilanceAnna Hegerius (Uppsala Monitoring Centre, Uppsala, Sweden)

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Symposium 3 (Cont) 16:00 – 17:30 Room 2 Symposium 4 (Cont) 16:00 – 17:30 Room 3&4

17:00 - 17:20 Results Baseline Assessment/PVRoad Map 2Abdela Kasso (Food, Medicine and Health Care Administration and Control Authority (FMHACA), Ethiopia)

17:00 - 17:15 O-008 Learning By Doing – Implementation Of Pharmacovigilance In The Clinical Setting In A National Referral Hospital In Kenya Faith Apolot Okalebo (Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, Kenya)

17:20 - 17:30 Discussion 17:15 - 17:30 O-009 Long Term And Clinical Effects Of A Pharmacovigilance Educational Intervention In Specialist Oncology NursesMichael Reumerman (VU University Medical Center (VUmc), Netherlands)

‘Going Further Together’ 17:30 – 18:00 Room 3&4

17:30 -18:00 A film about global medicines safety from Uppsala Monitoring Centre


CONFERENCE PROGRAMME TUESDAY 13 NOVEMBER 2018

Session A 08:30 – 09:45 Room 2 Session B 08:30 – 09:45 Room 3&4

O-010 Communication - The Key To Implementation Of Risk Management And Patient Safety In partnership with the ISoP Special Interest Group for Medicinal Product Risk Communication (CommSIG) Chairs: Priya Bahri (EMA, Netherlands), Katarina Ilich (USA) and Ulrich Hagemann (Germany)

Role Of The Pharmaceutical Industry In Enhancing Pharmacovigilance Chairs: Ambrose Isah (University of Benin/ University of Benin Teaching Hospital, Nigeria) and Jayesh Pandit (Bayer, Kenya)

08:30 - 08:35 Welcome And Session Objective 08:30 - 08:40 A Global Overview Of Pharmaceutical Industry’s Reports from the UMCPia Caduff (Uppsala Monitoring Centre/UMC, Sweden)

08:35 - 08:42 Risk Communication With Patients – Clear Questions, Clear Responses?Francois Houÿez (EURORDIS, France)

08:40 - 08:53 Perspectives From AfricaJayesh Pandit (Bayer, Kenya)

08:42 - 08:47 Urgent and important: good information on medicines for women worldwideBruce Hugman (Uppsala Monitoring Centre, Sweden)

08:47 - 08:52 O-011 Human factor science for improving the impact of risk communicationBrian Edwards (Chair Pharmaceutical Ergonomics & Human Factors Group, UK)

08:53 - 09:06 Perspectives From Asia And Middle EastMayada Alkhakany (Boehringer Ingelheim, United Arab Emirates)

08:52 - 08:57 O-012 Health Care Communication Empowerment – a successful programme in ColombiaAngela Caro Rojas (Colombian Pharmacovigilance Association, Colombia)

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Session A (Cont) 08:30 – 09:45 Room 2 Session B (Cont) 08:30 – 09:45 Room 3&4

08:57 - 09:02 O-013 Central To Risk Communication In Healthcare – The National Pharmacovigilance Centre In TunisiaRiadh Daghfous (Tunisian National Centre of Pharmacovigilance, Tunisia)

09:06 - 09:19 Perspectives From EuropeEsteban Herrero-Martinez (AbbVie, UK)

09:02 - 09:07 Risk Management For Anticoagulants – A Multi-Stakeholder Project In IsraelIrene Fermont (ISoP Israel Chapter, Israel)

09:07 - 09:12 Coordinated Communication – In Crises And In Everyday Work.Stina Wessling (CIP, Sweden)

09:19 - 09:32 Perspectives From The USVéronique Kugener (Takeda, USA)

09:12 - 09:45 Wrap-Up And Conclusions 09:32 - 09:45 Discussion




Session C 10:00 – 11:15 Room 2 Session D 10:00 – 11:15 Room 3&4

Pharmacovigilance Of Medical Devices Chairs: Jeff Aronson (Centre for Evidence - Based Medicine, UK) and Jitendar Sharma (Andhra Pradesh MedTech Zone /AMTZ, India)

Benefit Risk Assessment In PharmacovigilanceChair: Jan Petracek (PrimeVigilance, Czech Republic)

10:00 - 10:15 O-015 What Is A Device? Definition And ClassificationJeffrey K Aronson (Centre for Evidence-Based Medicine, UK)

10:00 - 10:25 Recent Published Failures Of Benefit Risk Management Systems – Lessons Learned”Jan Petracek (PrimeVigilance, Czech Republic)

10:15 - 10:30 What Harms Do Devices Cause?Robin E Ferner (West Midlands Centre for Adverse Drug Reactions, UK)

10:25 - 10:45 Benefit-Risk Evaluation: The Past, The Present And The Future.Juhaeri Juhaeri (Sanofi, USA)

10:30 - 10:45 A Test Case: Adverse Reactions To Vaginal Mesh The Patient’s PerspectiveKath Sansom (Sling The Mesh, UK)

10:45 - 11:05 Quantitative Approaches To Benefit-Risk Assessment In Pharmacovigilance: Are We Up To The Challenge?Ola Caster (Uppsala Monitoring Centre, Sweden)

10:45 - 11:00 A Test Case: Adverse Reactions To Vaginal Mesh The regulatory perspectiveCarl Heneghan (Centre for Evidence-Based Medicine, UK)

11:05 - 11:15 O-016 A Multidisciplinary Management Of Oncologic Patients Treated With Immune Checkpoint Inhibitors (Icpi)Agnès Lillo-Le Louët (Pharmacovigilance Hospital European Georges Pompidou, France)

11:00 - 11:15 Discussion

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CIOMS Lecture 11:15 – 12:15 Room 2

“New use of clinical concepts in MedDRA: Can MedDRA labelling groupings help to standardise safety labelling?”Chairs: Hervé Le Louët (President of CIOMS) and Victoria Rollason (Chair of the Local Organising Committee)

11:15 - 11:30 Introduction Hervé Le Louët, President of the Council for International Organizations of Medical Sciences (CIOMS), France

11:30 - 12:00 Speakers: William Gregory (Pfizer, USA), Sonja Brajovic (FDA, USA), Ilona Grosse-Michaelis (Bayer, Germany)



13:15 – 14:00 ISoP General Assembly

The Bengt Erik Wiholm Lecture and Expert Panel 14:00 – 15:30 Room 2

“Putting Patients First in Pharmacovigilance” Chairs: Mira Harrison-Woolrych (ISoP Secretary General, NZ) and Linda Harmark (Pharmacovigilance Centre Lareb, Netherlands)

14:00 -14:30 Patient Modulation Of Risks Relating To Medicines Pharmacovigilance Initiatives For Patients And Their OrganisationsSpeaker: Francois Houÿez (EURORDIS, France)

14:30 -15:00 O-017 Management of Adverse Experiences from the Use of Herbal Medicines: The Consumers’ PerspectivesSpeaker: Chuenjid Kongkaew (Naresuan University, Thailand)

15:00 – 15:30 Round Table Discussion With International Experts On Patient PerspectivesPanelists: François Houÿez, Chuenjid Kongkaew, Kawaldip Sehmi (IAPO, UK), George Sabblah (Ghana Pharmacovigilance Centre, Ghana)





Need For A Joined Up Strategy To Optimize Use Of Medicines For HIV/AIDS, TB, And Diabetes Chairs: Jing Bao (Frontier Biotechnologies, Inc, China) and Brian Edwards Chair (Pharmaceutical Ergonomics & Human Factors Group, UK)

Promotion Of Pharmacovigilance, As A Professional Pharmaceutical Service: The Experience Of Joint Work Between Academia, Pharmaceutical Associations And The Pharmaceutical Industry Chair: Victoria Hall Ramírez (University of Costa Rica, Costa Rica)

16:00-16:25 O-020 Systems Factors Associated With The Use Of Intravenous Insulin Infusions – Current Evidence And Future DirectionsBrian Edwards (Chair Pharmaceutical Ergonomics & Human Factors Group, UK)

16:00 - 16:30 O-018 Efforts Made By The University In Costa Rica To Promote PharmacovigilanceVictoria Hall Ramírez (University of Costa Rica, Costa Rica)

16:25 - 16:50 O-021 Strengthening HIV Pharmacovigilance In ChinaJing Bao (Frontier Biotechnologies, Inc., China)

16:30 - 17:00 O-019 How The Colombian Pharmacovigilance Association Join The Stakeholders In Pharmacovigilance, And Promote The Best Practices In Latam?Ángela Caro Rojas (Colombian Pharmacovigilance Association, Colombia)

16:50-17:15 O-022 Clinical Application And Regulation On Oral Medicines For Diabetes In China: Current Status And Further PerspectiveJukai Huang (Dongfang Hospital, Beijing University of Chinese Medicine, China)

17.00-17.30 Discussion


19:00 – 00:00 Conference Dinner

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CONFERENCE PROGRAMME WEDNESDAY 14 NOVEMBER 2018


Why Do So Many People Receive Treatments They Do Not Need And What Can We Do About It? Chairs: Ralph Edwards (Uppsala Monitoring Centre, Sweden) and Craig Hartford (Pfizer, UK)

Current Challenges In Data Collection On Safety Regarding Drug Use During Pregnancy And Breastfeeding Session sponsored by the ISoP Special Interest Group for Women’s Medicines Chair: Mira Harrison-Woolrych (ISoP Secretary General, NZ) and Agnes Kant (Pharmacovigilance Centre Lareb, Netherlands)

08:30 – 08:35 Brief opening remark from the ChairsRalph Edwards (Uppsala Monitoring Centre, Sweden) and Craig Hartford (Pfizer, UK)

08:30 - 8:35 The Challenges In Data Collection On Safety Regarding Drug Use During Pregnancy And BreastfeedingLinda Harmark, (Pharmacovigilance Centre Lareb, Netherlands)08:35 – 08:55 Adverse Drug Reactions

Are Caused By MedicinesJoan-Ramon Laporte (Vall d’Hebron University Hospital, Spain)

08:55 – 09:15 Too Much Alteplase For Ischemic Stroke?Sir Richard Thompson (Royal College of Physicians, UK)

08:35 - 8:50 O-024 Opportunities of prospective observational ENTIS studiesCorinna Weber-Schoendorfer (Charité - Universitätsmedizin Berlin, Germany)

09:15 – 09:35 O-023 Universal Health Coverage Is Possible with Effective Pharmacovigilance at Current Expenditure Level in NigeriaEmmanuel Okoro (University of Ilorin, Nigeria)

08:50 - 9:05 O-025 A Population Based Cohort, PregnantSaskia Vorstenbosch (Pharmacovigilance centre Lareb, Netherlands)

09:35 – 09:55 Audience participation & interaction through Q&A, comments

09:05 - 9.20 O-026 Experience With The Who Central Registry For The Epidemiological Surveillance Of Drug Safety In Pregnancy Christine Halleux (WHO)

09:55 – 10:00 Summary & concluding remarks from the Chairs

09:20 - 10:00 Round Table Discussion

10:00 – 11:30 Coffee Break




O-027 Back To The Future: The Case Narrative And Artificial Intelligence Chair: Rebecca Chandler (Uppsala Monitoring Centre, Sweden)

Practical Aspects Of Pharmacovigilance In Resource-Limited Countries Chair: Hilda Ampadu (The African Collaborating Centre for Pharmacovigilance/ACC, Ghana)

10:30 - 10:40 IntroductionRebecca Chandler (Uppsala Monitoring Centre, Sweden)

10:30 - 10:48 O-029 Enhancing Pharmacovigilance In Sub-Saharan Africa: Sharing Experiences From A GSK Pilot Initiative In Malawi Olga Menang (PATH) and Viviane Jusot (GSK)

10:40 - 11:10 O-028 Information On Clinical Reasoning And Heuristics, A Missing Link In PharmacovigilanceEugene van Puijenbroek (Pharmacovigilance Centre Lareb / Netherlands)

10:48 - 11:06 O-030 Strengthening Pharmacovigilance Capacity For Vaccine Manufacturers In Low-And-Middle-Income CountriesOlga Menang (PATH)

11:10 - 11:40 O-033 Distilling The Value Of Narratives With Machine LearningLucie Gattepaille (Uppsala Monitoring Centre, Sweden)

11:06 - 11:24 O-031 Development Of Pharmacovigilance System In A Resource-Limited Country, The Experience Of Democratic Republic Of CongoDidier Nzolo (National PV Center, Democratic Republic of Congo)

11:24 - 11:42 O-032 Drug-drug interaction studies in the field: examples of South-North collaboration projects Andrea Kuemmerle (SwissTPH) / Samantha Akakpo (MMV)

11:40 - 12:00 Discussion 11:42 - 12:00 Discussion


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Symposium 11 13:00 – 14:30 Room 2 Symposium 12 13:00– 14:30 Room 3&4

Bringing Together Medication Safety, Human Factors And Improvement Science To Achieve “Medication Without Harm” Chair: Yogini Jani (Centre for Medicines Optimisation Research & Education, UK)

Risk Minimisation Interventions For Diverse Health Care Systems. Following-Up On CIOMS IX Chair: Jean-Christophe Delumeau (Bayer, Singapore)

13:00 - 13:10 IntroductionYogini Jani (Centre for Medicines Optimisation Research & Education, UK)

13:00 - 13:30 O-036 Establishing Criteria To Decide The Need For Risk Minimisation Interventions -And Their Type- Suitable For Diverse Health Care SystemsYola Moride (Faculty of Pharmacy, University of Montréal, Canada)

13:10 - 13:30 O-034 Similar Sounding Names In Medications Safety: Risky Or Not?Yogini Jani (Centre for Medicines Op-timisation Research & Education, UK)

13:30 - 14:00 0-035 Patient involvement in Adverse Drug Reaction detection and reportingRakhi Karwa (Purdue University College of Pharmacy, USA| Moi Teaching and Referral Hospital, Kenya) and Mercy Maina (Moi Teaching and Referral Hospital, Kenya)

13:30 - 14:00 O-037 Addressing the challenges affecting the implementation of routine risk minimisation and risk minimisation interventions in diverse countries.On behalf of the SiG Rmin Asia Jean-Christophe Delumeau (ISoP treasurer and Bayer, Singapore)

14:00-14:30 Medication Without Harm: Is There A Role For Improvement Science? Interactive SessionYogini Jani, Rakhi Karwa, Mercy Maina

14:00 - 14:30 Panel Discussion CIOMS IX, Four Years After. Moving To The Next Step Introduced and chaired by Prof. Hervé Le Louët Panelists:Yola Moride, Hervé le Louët, Jean-Michel Dogne (University of Namur, Belgium), Stefan Heaton (Bayer), WHO representative, Chao Pi Hu (Taiwan Chinese Taipei), Jean-Christophe Delumeau (Singapore)

14:30 - 16:00 Plenary lecture O-038 “Listening to Kasparov: Putting Human Experts Room 2 and Artificial Intelligence Together to create Advanced Pharmacovigilance” Chair: Bruce Donzanti (Genentech Inc., USA)Speakers: Shaun Comfort (Roche-Genentech PDSS IIDO, USA) and Monica Munoz (FDA, USA)

16:00 - 16:15 Poster Prize Awards Room 2

16:15 - 16:30 ISoP 2019 Presentation And Closing Remarks Room 2

16:30 End Of The Meeting / Tea And Coffee



POSTER LISTING284 posters have been successfully accepted for this year’s 18th ISoP Annual Meeting. Posters will be displayed in the exhibition hall area with half of the posters being displayed on Monday and half on Tuesday.

Poster judging will take place during the conference and the three best posters will be awarded during the poster prize ceremony on Wednesday 14 November 16:00 – 16:15.

Presenting authors are kindly requested to be present throughout the official poster viewing times (as specified above) but due to the large number of posters, the Poster Committee will not only view the posters during the official

sessions but during the conference on Monday and Tuesday.

Official poster session times are:

Assistance for poster mounting / dismantling will be available at the Poster desk located in the exhibition hall area.

SESSION 1 POSTER PRESENTATION MONDAY 12 NOVEMBER

Benefit-Risk Assessment And Risk Management In Pharmacovigilance

Poster No. | Abstract Paper Title Presenter

1 ISoP18-1436 Planning For Implementation Of A Structured Benefit-Risk Framework Within Industry Abimbola Cole, Takeda Pharmaceuticals, United States

2 ISoP18-1125 The Impact Of A Restrictive Regulatory Action On The Utilization Of Pregabalin Containing

Products In Saudi Arabia Amal Alshatri Almotiry, Saudi Food and Drug Authority (SFDA), Saudi Arabia

3 ISoP18-1074 Objectives And Design Of The Post-Authorization Studies Evaluating The Effectiveness

Of The Risk Minimization Measures In The Eu Pas Register Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania

4 ISoP18-1086 Process Indicators Vs. Correlated Endpoints In Studies Evaluating The Effectiveness Of Risk

Minimization Measures In The Eu Pas Register Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania

Date Time

Monday 12 November 10.45 - 11.1515.30 - 16.00

Tuesday 13 November 09.45 - 10.0015.30 - 16.00

5 ISoP18-1087 A Description Of Medicines Associated Safety Issues Evaluated Through A Referral Procedure

At The Eu Level Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania

6 ISoP18-1298 Cast Analysis Of Uk Pregnancies Reported During/After Isotretinoin Administration. Proposal

For Application In A Global Safety Study. Brian Edwards, NDA Regulatory Science LTD, United Kingdom

7 ISoP18-1477 Risk Factors Contributing To Insulin Prescription Errors In A Public Tertiary Care Hospital

In Sub Saharan Africa Dorothy Atieno Aywak - Aloyo, Kenyatta National Hospital, Kenya

8 ISoP18-1437 Management Of Medication Errors In Pharmacovigilance Centres: Case Of Morocco Ghita Benabdallah, CAPM WHO CC, Morocco

9 ISoP18-1032 Analysis Of The Risk Management Plans Submitted To The Rational Drug Use And

Pharmacovigilance Department At Jfda (2014-2017) Jaber Jaber, Jordan food and drug administration, Jordan

10 ISoP18-1303 Consideration Of Benefit-Risk Assessment And Risk Management In Clinical Research

Of Traditional Medicines Li Zhang, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, China

11 ISoP18-1174 A Comparison Of Safety-Related Label Changes For Medicines With And Without Major

Objections At Time Of Marketing Authorisation Lourens Bloem, Utrecht Institute for Pharmaceutical Sciences, Utrecht University,

Dutch Medicines Evaluation Board, Netherlands

12 ISoP18-1085 Risk Minimization Measures Of A Paediatric Orphan Drug For Treatment Of Neonatal Diabetes Manon Exposito, AMRING, France

13 ISoP18-1404 Practical Aspects Of Developing Relevant Key Performance And Quality Indicators

For Risk-Based Quality Management In Pharmacotherapy. Marina Alexandrovna Malikova, Boston University, Boston Medical Center, United States

14 ISoP18-1222 In Vivo Tests For Investigating Immediate Hypersensitivity To General Anesthetics Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia

15 ISoP18-1177 A Review Of Benefit-Risk Assessment Over The Product Lifecycle Milena Miljkovic, PrimeVigilance, Serbia

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POSTER LISTING16 ISoP18-1183 The Association Between Inappropriate Medication Use And Health-Related Outcomes Among

Nursing Home Residents: A Systematic Review And Meta-Analysis Pajaree Mongkhon, Faculty of Pharmaceutical Sciences, Naresuan University, University of Phayao, Thailand

17 ISoP18-1152 Is The Risk Of Linezolid To Cause Serotonin Syndrome Real In Routine Clinical Practice ? Paul M. Tulkens, Université catholique de Louvain, Belgium

18 ISoP18-1341 Anticoagulant Therapy In Patients With Atrial Fibrillation And Risk Of Bleeding: Interim Analysis

- Tyrion Study Sara Ferraro, University of Pisa, Italy

19 ISoP18-1130 Assessment Of Cyclosporine Blood Concentrations In Adults With Aplastic Anemia Riadh Daghfous, Clinical and Experimental Pharmacology Research Laboratory LR16SP02,

National Pharmacovigilance center, Tunisia

20 ISoP18-1386 Safety And Efficacy Of Tolvaptan In The Suisse Adpkd Cohort Stefan Russmann, drugsafety.ch, Swiss Federal Institute of Technology Zurich (ETHZ), Switzerland,

Clinic Hirslanden, Boston University School of Public Health, United States

Global Pharmacovigilance

21 ISoP18-1331 Drug-Induced Anaphylaxis In French And Vietnamese Pharmacovigilance Database 2010-2015:

A Social Pharmacology Discussion Jean-Louis Montastruc, Centre Hospitalier Universitaire, Faculté de Médecine de l’Université

Paul-Sabatier, France

23 ISoP18-1504 Toxic Epidermal Necrolysis Related To Lamotrigine: About A Case Amina Tebaa, Moroccan center of pharmacovigilance, Morocco

24 ISoP18-1364 Thyroid Dysfunction After Long-Term Treatment By Amiordarone Amina Tebaa, Poison and pharmacovigilance center of Morocco, Morocco

25 ISoP18-1510 Development Of Inhibitors In Hemophils A: About Four Case Amina Tebaa, Moroccan center of pharmacovigilance, Morocco

26 ISoP18-1202 Reporting Of Qt Interval Prolongation And Torsade De Pointe For Hiv-Antiretrovirals In Vigibase:

Focus On Potential Drug-Drug Interactions Anne Simon, Swiss Tropical and Public Health Institute, University of Basel, Switzerland

27 ISoP18-1362 Ecopharmacovigilance For Better Health In Ghana Cynthia Amaning Danquah, Kwame Nkrumah University of Science and Technology, Ghana

28 ISoP18-1064 Pharmacovigilance In Emerging Markets: An Industry Initiative To Strengthen Global

Engagement And Support Esteban Herrero Martinez, AbbVie, United Kingdom

29 ISoP18-1129 Spontaneous Reporting Of Suspected Adverse Drug Reactions In Patients

With Arthritis: A Scoping Literature And Data Review Gary Greer, University of Oxford, United Kingdom

30 ISoP18-1078 Tamoxifen And The Risk Of Parkinsonism: A Case Non-Case Study Jean-Louis Montastruc, Faculté de Médecine - Centre Hospitalier Universitaire, France

31 ISoP18-1118 Risk Of Diabetes Associated With Statins Fibrates And Their Association Jean-Louis Montastruc, Faculté de Médecine, France

32 ISoP18-1119 Fluoroquinolones And Aortic Aneurysms: What Are The Fluoroquinolones At Risk? Jean-Louis Montastruc, Faculte de Medecine, France

33 ISoP18-1324 Retrospective Study On Cutaneous Adverse Drug Reactions Induced By Antiepileptic Drugs Latifa Aït Moussa, cCntre Antipoison et de Pharmacovigilance du Maroc, Morocco

34 ISoP18-1372 Serious Adverse Drug Reactions: Experience From The Moroccan Pharmacovigilance Centre Latifa Aït Moussa, Centre Antipoison et de Pharmacovigilance du Maroc, Morocco

35 ISoP18-1221 Drug Sefty : In-Vitro Study Of Physicochemical Incompatibilities Of Injectable Antibiotics

Used In Pediatrics With Other Drugs In An Infusion Mustapha Bouatia, University Mohamed V, Rabat, Morocco

36 ISoP18-1359 Drug Sefty : Drug Incompatibilities In Intensive Care Mustapha Bouatia, University Mohamed V, Rabat, Morocco

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POSTER LISTING37 ISoP18-1256 Acetylsalicylic Acid Adverse Events: A Survey Of General Practitioners

In Democratic Republic Of Congo Odette Mapipi Mboma, University of Kinshasa, Congo, The Democratic Republic of the

38 ISoP18-1151 Psychiatric Adverse Drug Reactions With Anti-Hypertensive Treatment: Review & Analysis

Of Smpcs Pipasha Biswas, Symogen Limited, United Kingdom

39 ISoP18-1224 Comparison Of 4 Commonly Prescribed Antipsychotics Patient Information Leaflets

Of Indian Companies With The Original Smpc From Innovator Companies Pipasha Biswas, Symogen Limited, United Kingdom

40 ISoP18-1460 Factors Associated With Serious Medication Errors In Moroccan Pharmacovigilance

Database From 2006 To 2016 Rachida Soulaymani Bencheikh, Centre Anti Poison et de Pharmacovigilance du Maroc, Morocco

41 ISoP18-1254 Adverse Drug Reaction Reports Following A “Brand Switch”. The New Zealand Experience. Rhiannon Braund, University of Otago, New Zealand

Miscellaneous

42 ISoP18-1165 Social Media: The Battleground For Public Opinion On Medicines Safety Alexandra Hoegberg, Uppsala Monitoring Centre, Sweden

43 ISoP18-1354 Reporting Immune Related Adverse Events During Checkpoint Inhibitor Therapy Anne Leuppi-Taegtmeyer, University Hospital Basel, University Hospital Basel, Switzerland

44 ISoP18-1264 Adherence To Treatment Of Chronic Patients In General Practitioner Office-First Results

Of A Cross-Sectional Survey Camelia Bucsa, “Iuliu Hatieganu” University of Medicine and Pharmacy, Romania

45 ISoP18-1144 An Example Of Qualitative Signal Detection Within The French Signal Management Process Claire Ferard, ANSM, France

46 ISoP18-1497 Risk Perception Of Adverse Drug Reactions By Health Students – Influence Of

Undergraduate Education Cristiano Matos, Coimbra Health School, Portugal, Faculty of Pharmacy, University of Seville, Spain

47 ISoP18-1416 Reducing Prescribing Errors Associated With In-Patient Electronic Prescribing Systems: An

Investigation Of Pharmacist Interventions Fahad Alshahrani, University of Birmingham, United Kingdom

48 ISoP18-1412 Exploring Health Professionals Perceptions About Drug Related Problems In Older Patients Fátima Roque, Research Unit for Inland Development, Polytechnic Institute of Guarda (UDI/IPG), Portugal

49 ISoP18-1297 Impact Of The Doctor-Patient Relationship On Non-Compliance With Pharmacological Medical

Prescription In Chronic Disease. A Cross-Sectional Study Fátima Roque, Research Unit for Inland Development (UDI/IPG), Health Sciences School,

Polytechnic of Guarda (ESS/IPG), Portugal

50 ISoP18-1299 Factors Of Non-Adherence To Therapy In Chronic Patients With Pathologies Covered By Specific

Legislation In Portugal Fátima Roque, Research Unit for Inland Development (UDI/IPG), Health Sciences School,

Polytechnic of Guarda (ESS/IPG), Portugal

51 ISoP18-1280 Nurses’ Experiences, Attitudes And Perspectives About Adrs And Reporting In The Netherlands Gerda Weits, Netherlands Pharmacovigilance Centre Lareb, Netherlands

52 ISoP18-1098 Awareness Survey On Drug-Drug Interactions Among Argentinean Health Care Professionals Guadalupe Darderes, GADOR S.A., Argentina

53 ISoP18-1117 Pvknow: A Pharmacovigilance Knowledge Management System Jeltje Boer, Netherlands Pharmacovigilance Centre Lareb, Netherlands

54 ISoP18-1282 The Impact Of Facilitated Reporting Of Adverse Drug Reactions By Health Care Professionals

As A New Source Of Adr Information Jette van Lint, Netherlands Pharmacovigilance Centre Lareb, Netherlands

55 ISoP18-1133 Framework For Analyzing Consumer Health Questions Joyce Cao, Herbalife Nutrition, United States

56 ISoP18-1495 Overview Of Adverse Reactions (Adrs) For Elderly Patients Reported In 2017 In Croatia Katarina Gvozdanovic, Agency for Medicinal Products and Medical Devices of Croatia, Croatia

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POSTER LISTING57 ISoP18-1272 Comparison Of Reported Adverse Events Of Premature And Term Born Infants Following

Childhood Vaccinations In The Netherlands Leontine van Balveren, Netherlands Pharmacovigilance Centre Lareb, Netherlands

58 ISoP18-1094 Expectedness Of Antimicrobials Adverse Drug Reactions In Iraqi, 2010-2017 Manal Mohammed Younus, MOH, Iraq

59 ISoP18-1185 Process Characteristics And Time To Follow-Up Of Adverse Drug Reaction Reports

From A Single Center: A Retrospective Analysis Matthias Ganso, Department of Medicine, ABDA - Federal Union of German Associations

of Pharmacists, Germany

60 ISoP18-1420 Multiple Drugs Neosensitization Following Dress Syndrome Induced By Cotrimoxazole Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia

61 ISoP18-1488 Cetuximab-Induced Acneiform Eruption Resistant To Doxycycline Preventive

And Curative Therapy Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia

62 ISoP18-1489 Cerolizumab Pegol-Induced Palmoplantar Pustulosis Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia

63 ISoP18-1334 Impact Of Quality And Outcomes Framework On Prevalence Of Chronic Kidney Disease

In United Kingdom Moninder Kaur, Cognizant Technology Solutions, United Kingdom

64 ISoP18-1377 Adverse Drug Reactions Arising From The Use Of The Products Outside The Terms

Of The Marketing Authorisation Nikica Mirošević Skvrce, Agency for Medicinal Products and Medical Devices, Croatia

65 ISoP18-1066 What German Physicians Think About The Spontaneous Reporting System And How

They Would Change It. Results Of An Online Survey Thomas Stammschulte, Drug Commission of the German Medical Association, Germany

Patient Involvement In Pharmacovigilance

66 ISoP18-1187 Contribution Of Patient’S Reports In Signal Detection: Experience Of

A Pharmacovigilance Center Agnès LILLO-LE LOUET, Pharmacovigilance Hopital Européen Georges Pompidou, France

67 ISoP18-1509 Lyell Syndrome With Carbamazépine And Amoxicilline: Clinical Case Amina Tebaa, Poison and pharmacovigilance center, Morocco

68 ISoP18-1307 Understanding Paediatric Patients’ Pharmaceutical Needs Post Discharged From

A Hospital: An Exploration Study Asia Rashed, King’s College London, Evelina London Children’s Hospital, Guy’s & St Thomas’

NHS Foundation Trust, United Kingdom

69 ISoP18-1263 Patient Reporting Of Adverse Drug Reactions In Romania-Pilot Phase

Of A Cross-Sectional Survey Camelia Bucsa, “Iuliu Hatieganu” University of Medicine and Pharmacy, Romania

70 ISoP18-1250 Contribution Of Patients To Pharmacovigilance – The Views Of European Patient Organizations Cristiano Matos, Faculty of Pharmacy, University of Seville, Spain, Coimbra Health School - IPC, Portugal

71 ISoP18-1128 Monitor The Benefit And Risk Of Medicines In Primary Care; Building A Bridge Between

Daily Practice And Research Eugene van Puijenbroek, Netherlands Pharmacovigilance Centre Lareb, University of Groningen, Groningen

Research Institute of Pharmacy, Unit of PharmacoTherapy, - Epidemiology & -Economics, Netherlands

72 ISoP18-1430 What Think Older Patients About Their Medicines? Fátima Roque, Research Unit for Inland Development, Polytechnic Institute of Guarda (UDI/IPG), Portugal

73 ISoP18-1345 Consumers’ Contributions To Pharmacovigilance For Herbal Medicines –Analyses

Of Global Reports In Vigibase® Florence Van Hunsel, The Netherlands Pharmacovigilance Centre Lareb, Netherlands

74 ISoP18-1415 Patient Knowledge Of Adverse Drug Reaction Reporting Karamjit Badyal, West Midlands Centre for Adverse Drug Reactions, University of Birmingham,

United Kingdom

75 ISoP18-1467 Active Surveillance Of Adverse Events Following Immunization (Aefi) Using Both

Paper Forms And Sms Laura Gonella, University of Verona, Italy

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POSTER LISTING76 ISoP18-1101 The Degree Of Impact Of Adverse Drug Reactions As Experienced By Patients Michelle Haaksman, Netherlands Pharmacovigilance Centre Lareb, Netherlands

77 ISoP18-1068 An Ecological Study On Consumer Adverse Event Reporting To The Us Food

And Drug Administration Monica Munoz, US Food and Drug Administration, University of Florida, United States

78 ISoP18-1496 A Mysterious Resistance To Acenocoumarol! Riadh Daghfous, Centre National de Pharmacovigilance, Tunisia

79 ISoP18-1492 Adverse Drug Reactions Leading To Ocular Surface Disease Clinic Visits At An Eye Hospital:

A Brief Report Safa Alizadeh, Tehran University of Medical Sciences, Iran, Islamic Republic Of

80 ISoP18-1053 The Moroccan Phytovigilance System: An Experience Of Involving Patients From 2012 To 2016 Souad Skalli, Faculty of Sciences, Mohammed V University In Rabat, Morocco

81 ISoP18-1056 Chronic Disease Sufferers’ Willingness To Participate In Spontaneous Adverse Drug

Reaction Reporting System Violeta Getova, Medical University of Plovdiv, Bulgarian drug agency, Bulgaria

Pharmacovigilance And The Pharmaceutical Industry

82 ISoP18-1320 The Impact Of Pharmacovigilance Oversight On Expanded Access Programs (Eaps)

With Nivolumab In Bristol-Myers Squibb Turkey Belce Cilmi Arslan, Bristol-Myers Squibb Ilacları Inc. Istanbul, Turkey, Turkey

83 ISoP18-1021 Developing A New Methodology For Preparing A Guideline: The Case Of Good

Pharmacovigilance Outsourcing Practices Brian Edwards, ACRES, United Kingdom

84 ISoP18-1216 Pharmacovigilance In Bioequivalence Studies: Is There A Difference In The Prevalence

Of Adverse Events Between Original And Generic Medicines ? Mustapha Bouatia, Mohammed V University, Faculty of Medicine and Pharmacy, Morocco

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Pharmacovigilance in Resource-Limited Countries

85 ISoP18-1279 Serious Adverse Drug Reaction Reports In The Nigerian Vigiflow Database

From September 2004 To December 2016 Ali Ibrahim, NAFDAC, Nigeria

86 ISoP18-1173 Vaccine Safety Surveillance In Pregnancy Using Gaia Definitions For Neonatal Conditions:

A Feasibility Assessment In Low- And Middle-Income Countries Anke L. Stuurman, P95 Epidemiology and Pharmacovigilance Consulting and Services, Belgium

87 ISoP18-1505 The New Pharmacovigilance Guidance In India- Diluted Wine In A Borrowed Bottle Anupama Ramkumar, Arkus Research Pvt Ltd, India

88 ISoP18-1400 Management Of Individual Case Safety Reports From Multiple Source

In The Drc National Pharmacovigilance Center ARNOLD NSEKA ZI NSEKA, National Pharmacovigilance Center, Congo, The Democratic Republic of the

89 ISoP18-1267 An Online Collaborative, Open Access Pharmacovigilance Platform

For Resource-Limited Countries Elizabeth Allen, University of Cape Town, South Africa

90 ISoP18-1161 Online Availability Of Regulatory Documents, Safety Information And Adverse Drug Reaction

Reporting In African Countries Hanneke Dominicus, Dominicus Medicus Consultancy, Consortium for African Regulatory expertise

Development, Netherlands

91 ISoP18-1045 Drug- Or Herb- Induced Liver Injury In China Jia-Bo Wang, Beijing 302 Hospital of China, China National Advisory Council of Traditional Chinese

Medicines-Induced Liver Injury, China

92 ISoP18-1403 Pharmacovigilance Intensive During The Administration For Perfusion Of Non-Innovative

Rituximab In The Rebagliati Hospital From March To June 2015 Liz Aliaga, Hospital Rebagliati- EsSalud, Peru

93 ISoP18-1517 Surveillance Of Anti-Tuberculosis Drugs In Thailand Pakawadee Sriphiromya, Ministry of Public Health, Thailand

94 ISoP18-1252 Present Status And Future Prospects Of Pharmacovigilance In Nepal Renu Karki, Pokhara University, Nepal


POSTER LISTING95 ISoP18-1507 Pharmacovigilance System In Arabic Countries: A Systematic Review Of 22 Arab Countries Thamir Alshammari, University of Hail, Saudi Food and Drug Authority, Saudi Arabia

96 ISoP18-1232 The Experience Of Using Khartoum Medicines Information Center (Khmic) As A Focal Point

To Enhance Pharmacovigilance In Sudan Tsneem Yousef, Ministry of Health Khartoum State, Sudan

97 ISoP18-1262 Opinion Of Costa Rican Pharmacists Regarding A New Adverse Drug Reaction

Reporting Platform, 2017 Victoria Hall Ramirez, University of Costa Rica, Costa Rica

98 ISoP18-1140 Factors Influencing Low Adverse Drug Reaction Reporting Among Healthcare

Professionals In Ghana Walter-Rodney Nagumo, University Of Sheffield, United Kingdom

99 ISoP18-1512 Implementation Of Medication Errors Reporting Tools In Two Teaching Hospitals In Kinshasa Yves Lula, University of Kinshasa/National Pharmacovigilance Centre, Congo, The Democratic Republic of the

99.a ISoP18-1054 Frequency Of Regulatory Breach Of Risk Management Plans In Mexico. Octavio Alejandro Enríquez Lara, Federal Comission for Health Risks Protection, Mexico

99.b ISoP18-1443 Use Of Pharmacovigilance Data Mining For Signal Detection In The Mexican

Pharmacovigilance National Center Spontaneous Reports Database. Raymundo Castillo Del Valle, Federal Comission for Health Risks Protection, Mexico

Pharmacovigilance Of Medical Devices

100 ISoP18-1321 Reporting Point Side Effects Medical Implants: Experiences After One Year Carolina Molto-Puigmarti, RIVM, Meldpunt en Expertisecentrum Bijwerkingen Implantaten, Netherlands

101 ISoP18-1035 Herpes Simplex Virus Encephalitis After Deep Brain Stimulation For Epilepsy: A Case-Report Marylaure GAVARD, Grenoble Alpes University Hospital, France

102 ISoP18-1219 Dress Syndrome Associated With Diclofenac Ons Charfi, National Centre of Pharmacovigilance of Tunisia, Tunisia

103 ISoP18-1220 Doxycycline Induced Generalized Bullous Fixed Drug Eruption: 2 Case-Reports Ons Charfi, National Centre of Pharmacovigilance of Tunisia, National Centre of Pharmacovigilance

of Tunisia, National Centre of Pharmacovigilance of Tunisia, Tunisia

104 ISoP18-1309 Apipuncture Induced Urticaria With Recurrence Following Honey Contact Ons Charfi, National Centre of Pharmacovigilance of Tunisia, Tunisia

105 ISoP18-1318 Neosensitization To Multiple Drugs Following Carbamazepine Dress Syndrome. Ons Charfi, National Centre of Pharmacovigilance of Tunisia, Tunisia

Risk Communication In Pharmacovigilance

106 ISoP18-1439 Role Of Patient Information On The Adverse Effects Of Medicines In Oncology AMINA TEBAA, ministry of health, Morocco

107 ISoP18-1461 Media-Vigilance Moroccan Experience Amina Tebaa, Centre Antipoison et de Pharmacovigilance, Morocco

108 ISoP18-1154 Amusing Ourselves To Death: How Science And Reason Are Losing Their Grip

In Public Discourse Bruce Peter John Hugman, Uppsala Monitoring Centre, Sweden, United Kingdom

109 ISoP18-1483 Drug Safety Alert - Time To Action Christopher Anton, West Midlands Centre for Adverse Drug Reactions, United Kingdom

110 ISoP18-1227 Pharmacists’ Role In Risk Communication On Self-Medication – Pilot Study From Bulgaria Hristina Viktorova Lebanova, Faculty of Pharmacy, Medical University-Pleven, Bulgaria

111 ISoP18-1462 Iatrogenic Adrenal Insufficiency Following Use Of Corticosteroids In Hiv Infected Patients

Receiving Cobicistat-Based Antiretroviral Regimen Roseline Ing-Lorenzini, Hôpitaux Universitaires de Genève, Switzerland, Switzerland

112 ISoP18-1481 Signal Detection And Risks Communication In Pharmacovigilance

For Cardiovascular Clinical Trials. Marina Alexandrovna Malikova, Boston University, Boston Medical Center, United States

113 ISoP18-1097 High Dose Methotrexate Delayed Elimination: A Case Series. Thierry TRENQUE, Reims University Hospital, France

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POSTER LISTINGSignal Detection

114 ISoP18-1092 Doxycycline Associated Fixed Drug Eruptions Safety Review Abdulaziz Alakeel, Saudi Food and Drug Authority, Saudi Arabia

115 ISoP18-1146 Alopecia Occurred With Infliximab: What Link? Clinical Case Amina Tebaa, Poison and pharmacovigilance center of Morocco, Morocco

116 ISoP18-1178 Cognitive Patterns In Pharmacovigilance Assessments Birgitta Grundmark, Uppsala Monitoring Centre, Uppsala University, Sweden

117 ISoP18-1326 Safety Profile Of Sodium-Glucose Co-Transporter-2 (Sglt2) Inhibitors: A Retrospective

Study Of The Portuguese Pharmacovigilance System Database Diogo Mendes, AIBILI, Portugal

118 ISoP18-1080 Characterization And Disproportionality Analysis Of Spontaneously Reported Cases

Of Medication Errors To The U S-F D A Adverse Event Reporting System Faizan Mazhar, Università di Milano, Milan, Italy, Italy

119 ISoP18-1409 Detecting A Potential Signal Of Quetiapine Abuse Using The Faers Database

And Big Data Search Analytics Georgios Papazisis, School of Medicine, Aristotle University of Thessaloniki, Greece

120 ISoP18-1311 Qualitative Method To Detect Signals And Manage Alerts In Pharmacovigilance

“From Identification To Actions” Houda Sefiani, CAPM, R.CC, Morocco

121 ISoP18-1269 Exploring The Association Between Monoclonal Antibodies And Depression

And Suicidal Ideation And Behavior: A Vigibase Study Lotte Minnema, Utrecht Institute for Pharmaceutical Sciences (UIPS),

Medicines Evaluation Board, Netherlands

122 ISoP18-1110 Who’S At Risk? Identifying Risk Groups For Adverse Drug Reactions Using Vigibase Lovisa Sandberg, Uppsala Monitoring Centre, Sweden

123 ISoP18-1123 Drospirenone And Its Association With Gall Bladder Diseases: A Retrospective Study

Of Canadian Adverse Drug Reaction Monitoring Program , 1965-2017 Manan Shah, Nirma University, India

124 ISoP18-1401 From Clinical Trial To Post-Marketing Signal Management: A Continuum Margot Stam Moraga, IQVIA RDS AG, Switzerland

125 ISoP18-1171 Cox Selectivity And Chemical Subgroup Of Non-Steroidal Anti-Inflammatory Drugs

And Frequency Of Spontaneous Reporting Of Hypersensitivity Reactions Olaf Klungel, Universiteit Utrecht, Universiteit Utrecht, Netherlands

126 ISoP18-1246 Signals Detection In Pharmacovigilance Based On The Seriousness Of Adverse Drug Reactions,

Moroccan Pharmacovigilance Database, 2008-2017 Rachida Soulaymani-Bencheikh, Centre Anti Poison et de Pharmacovigilance du Maroc, Morocco

127 ISoP18-1135 Hepatotoxicity With A Natural Dietary Supplement, Artemisia Annua L. Extract In Grapeseed

Oil. New Zealand Pharmacovigilance Centre Reports. Ruth Lesley Savage, University of Otago, New Zealand

128 ISoP18-1453 Importance Of Background Information Of The National Immunization Program

For Children In Vaccine Signal Detection Wil Hilgersom, The Netherlands Pharmacovigilance Centre Lareb, Netherlands

129 ISoP18-1456 A Systematic Step-By-Step Approach To Vaccine Signal Detection Wil Hilgersom, The Netherlands Pharmacovigilance Centre Lareb, Netherlands

Teaching Pharmacovigilance

130 ISoP18-1138 Pharmacovigilance Awareness In Healthcare Professionals Emine Defne Aral Karakulak, Konya Beyhekim State Hospital, Turkey

131 ISoP18-1268 Pharmacovigilance Teaching To Undergraduates Of Medicine And Surgery School:

The Experience Of Verona University Lara Magro, University of Verona, Italy

132 ISoP18-1315 Ten Years Of Experience In Graduate And Postgraduate Education In Pharmacovigilance Nikica Mirošević Skvrce, Agency for Medicinal Products and Medical Devices, Croatia

133 ISoP18-1302 Undergraduate Pharmacovigilance Education : Moroccan Experience Samira Serragui, Faculty of Medicine and Pharmacy, Morocco

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POSTER LISTINGWomen’s Health, Including Contraceptive Medicines And Devices

134 ISoP18-1327 A Study Regarding The Frequency Of Adverse Reactions In The Infertility Treatment Anca Butuca, ULB Sibiu, Romania

135 ISoP18-1126 Outcomes Of Drug Exposition During Pregnancy: Analysis From A Teratology

Information Service. Camille Lenoir, Geneva University Hospitals & Geneva University, Switzerland

136 ISoP18-1104 Gender Differences In Adverse Drug Reaction Reports; How Can They Be Explained? Eugene van Puijenbroek, Pharmacovigilance Centre Lareb, University of Groningen, Netherlands

137 ISoP18-1022 Fetal Effects Of Serotonin-Noradrenaline Reuptake Inhibitor Use During Pregnancy Florence Martin, Newcastle University, United Kingdom

138 ISoP18-1191 Pregnancies Associated With Etonogestrel Implants: Comparison Of Two Five-Year

Reporting Periods Mira Harrison-Woolrych, ISoP, United Kingdom

139 ISoP18-1393 Massive Bilateral Pulmonary Embolism Induced By Estradiol Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

140 ISoP18-1406 Lichenoid Drug Eruption Induced By Levonorgestrel Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

142 ISoP18-1176 Antihypertensives Prescribed For Pregnant Women In Japan: Prevalence And Timing

Determined From A Database Of Health Insurance Claims Tomofumi Ishikawa, Tohoku University Graduate School of Pharmaceutical Sciences, Japan

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POSTER LISTING SESSION 2 POSTER PRESENTATION TUESDAY 13 NOVEMBER

Artificial Intelligence/Machine Learning In Pharmacovigilance (Or New Technologies In Pharmacovigilance)

Poster No. | Abstract Paper Title Presenter

143 ISoP18-1197 Training An Augmented Intelligent System For Pharmacovigilance: Practical

Considerations And Guidance Danielle Abatemarco, Celgene Corporation, Celgene Corporation, United States

144 ISoP18-1199 Augmented Intelligence And The Future Of The Drug Safety Professional Karolina Danysz, Celgene, Switzerland

145 ISoP18-1356 Screening Of Discharge Letters To Detect Adverse Drug Reactions. Can Natural Language

Processing Tools Be Helpful? Kuntheavy Ing Lorenzini, University Hospitals of Geneva, Switzerland

146 ISoP18-1468 Automatic Encoding Of Adrs In Italian Spontaneous Reporting System Laura Gonella, University of Verona, Italy

147 ISoP18-1102 Automatic Detection And Removal Of Personal Identifiers In Case Narratives

Using Deep Learning Lovisa Sandberg, Uppsala Monitoring Centre, Sweden

148 ISoP18-1158 Adverse Event Recognition In Tweets: Results From A Web-Radr Project Lucie Gattepaille, Uppsala Monitoring Centre, Sweden

149 ISoP18-1226 Development And Validation Of A Model Predictive Of Case Inclusion

In Pharmacovigilance Reviews Monica Munoz, US Food and Drug Administration, University of Florida, United States

150 ISoP18-1215 Drug Safety: In Vitro Study Of Physicochemical Incompatibilities Of Infusion Medications

Linked To Ph Variation Mustapha Bouatia, University Mohamed V, Rabat, Morocco


POSTER LISTING151 ISoP18-1261 Development, Validation And Implementation Of An Active Electronic Pharmacovigilance

System In Hospitalized Patients Raffaela Bertoli, Institute of Pharmacological Sciences of Southern Switzerland, Division of Clinical

Pharmacology and Toxicology, Ente Ospedaliero Cantonale, Switzerland

152 ISoP18-1192 A Framework For Identifying And Validating Cognitive Services Within Pharmacovigilance Ruta Mockute, Celgene Corporation, Celgene Corporation, United States

153 ISoP18-1361 A Framework For Leveraging Emerging Technologies In Pharmacovigilance Edward Mingle, Celgene Corp, United States

154 ISoP18-1455 A Novel Approach To Standardizing Data & Detecting Duplicates Across Adverse Event

Data Sources Using Machine Learning Sameen Desai, Celgene Corp, United States

155 ISoP18-1131 Facilitating Safety Signal Triage And Prioritization Through Literature Based Matrix Factorization

Ranking Of Drug And Designated Medical Event Pairs Scott Spangler, IBM Research-Almaden, United States

156 ISoP18-1198 Cognitive Services For Pharmacovigilance Transformation Ramani Routray, IBM Watson Health, United States

157 ISoP18-1156 From Database To Diagnosis: ‘Intelligent Query’, A Tool To Help With Safety Signal Evaluation Vivek Samal, GSK, Belgium

158 ISoP18-1153 A Prospective Evaluation Of Mcem Method For Drug Safety Signal Detection

In Spontaneous Reporting Systems Ying Li, IBM Research, United States

Pharmacovigilance And Public Health

159 ISoP18-1316 Comparison Of Drug-Induced Stevens - Johnson Syndrome / Toxic Epidermal Necrolysis

In French And Vietnamese Database (2010-2015) Jean-Louis Montastruc, Centre Hospitalier Universitaire, Faculté de Médecine de l’Université Paul-Sabatier,

France

160 ISoP18-1266 Evaluation Of Drug-Related Health Problems By Diagnosis In Children Ahmet Akici, Marmara University, Turkey

161 ISoP18-1189 Example Of Using Pharmacogenetics For Drug Safety: Prevalence Of The Cyp2c19*2

Polymorphism And Clopidogrel Resistance In Moroccan Population Amina Tebaa, Moroccan Anti Poison and Pharmacovigilance Center, Morocco

162 ISoP18-1204 Adverse Effects In Elderly Subjects: Experience Of The National Pharmacovigilance

Center Of Morocco Amina Tebaa, Antipoison and Pharmacovigilance Center of Morocco, Ministry of Health, Morocco

163 ISoP18-1217 Material Vigilance In A Hospital Amina Tebaa, Ministry of Health’s Poison Control and Pharmacovigilance Center, Morocco

164 ISoP18-1231 The Purchase Of Health Products Via The Internet: Health Issues And Perspectives AMINA TEBAA, Ministry of Health, Morocco

165 ISoP18-1434 Acute Generalized Exanthematous Pustulosis Induced By Tenonitrozole Amina Tebaa, Antipoison and Pharmacovigilance Center of Morocco, Ministry of Health, Morocco

166 ISoP18-1502 Analysis Of Cases Of Hepatic Adverse Reactions With Antituberculosis Drugs In Morocco Amina Tebaa, Morroccan National Pharmacovigilance Center, Morocco

167 ISoP18-1170 Abciximab-Induced Delayed Thrombocytopenia: Case Analysis In The French

Pharmacovigilance Database Anaïs Maurier, CHU Angers, France

168 ISoP18-1207 Antibiotics Induced Adverse Drug Reactions In Hospitalized Pediatric Patients: Interim Results

From A Prospective Observational Study Camelia Bucsa, University of Medicine and Pharmacy ”Iuliu Hatieganu”, Romania

169 ISoP18-1275 Reactogenicity And Safety Of The Measles-Mumps-Rubella Vaccine: A Prospective

Observational Real World Study Camelia Bucsa, “Iuliu Hatieganu” University of Medicine and Pharmacy, Romania

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170 ISoP18-1096 Snapshot Of The Overprescription Of Proton Pump Inhibitors In A Primary Care Hospital. Camille Lenoir, Geneva University Hospitals & University of Geneva, Switzerland

171 ISoP18-1410 The Trend Of Reported Adverse Drug Reactions At Mbagathi Hospital’S Comprehensive

Care Centre In Nairobi,Kenya. Catherine Wambura, Mbagathi Hospital, Kenya

172 ISoP18-1181 Penicillin-Induced Acute Generalized Exanthematous Pustulosis: The Importance

Of Patch Testing. Chaker Ben Salem, Sousse University, Tunisia

173 ISoP18-1182 Anti-Epileptic Recurrent Drug-Induced Rash With Eosinophilia And Systemic Symptoms Bouraoui Ouni, Sousse University, Tunisia

174 ISoP18-1233 Sulfasalazine -Induced Dress Complicated By Hemophagocytic Lymphohistiocytosis

In An Adult Ulcerative Colitis Patient. Bouraoui Ouni, Sousse University, Tunisia

175 ISoP18-1234 Immediate Hypersensitivity Reaction To Acetylsalicylic Acid With Positive Skin Tests Bouraoui Ouni, Sousse University, Tunisia

176 ISoP18-1237 Allopurinol-Induced Overlapping Dress And Toxic Epidermal Necrolysis Bouraoui Ouni, Sousse University, Tunisia

177 ISoP18-1239 A Pediatric Case Of Severe Rhabdomyolysis In Acute Asthma Crisis Bouraoui Ouni, Sousse University, Tunisia

178 ISoP18-1241 Side Effects Of Targeted Therapies Bouraoui Ouni, Sousse University, Tunisia

179 ISoP18-1242 Skin Testing In Antibiotic Allergic Patients With Immediate And Delayed

Hypersensitivity Reactions Bouraoui Ouni, Sousse University, Tunisia

POSTER LISTING

180 ISoP18-1243 Lichenoid Eruption Induced By Methotrexate Bouraoui Ouni, Sousse University, Tunisia

181 ISoP18-1244 Sulfasalazine Induced Dress Syndrome With Fulminant Hepatitis Bouraoui Ouni, Sousse University, Tunisia

182 ISoP18-1277 Anaphylactic Shock Secondary To Blue Patent Administration With Positive Skin Tests Bouraoui Ouni, Sousse University, Tunisia

183 ISoP18-1283 Geant Blue Urticaria Secondary To Blue Patent Administration With Positive Skin Tests Bouraoui Ouni, Sousse University, Tunisia

184 ISoP18-1287 Hypersensitivity Reaction Following L-Asparaginase Administration: Skin Tests May

Be A Helpful To Confirm Diagnosis. Bouraoui Ouni, Sousse University, Tunisia

185 ISoP18-1290 Sulfasalazine Induced Drug Rash With Eosinophilia And Systemic Symptoms (Dress) Bouraoui Ouni, Sousse University, Tunisia

186 ISoP18-1396 Seizures Followings Immunization: About 27 Cases Riadh Daghfous, Centre national de pharmacovigilance de Tunis, Tunisia

187 ISoP18-1402 Side Effects Of Lipid-Lowering Agents: Case Series Of 53 Patients Riadh Daghfous, Centre national de pharmacovigilance de Tunis, Tunisia

188 ISoP18-1284 Ototoxicity Induced By Antineoplastic Therapy In Children - Review Cristiano Matos, Coimbra Health School, Portugal, Faculty of Pharmacy, University of Seville, Spain

189 ISoP18-1137 Using Who Recommendations Antibiotic Consumption Evaluation In Kazakhstan

For The Period 2012-2017 Dinara Utepova, RSE Republican Center for Healthcare Development” of the Ministry of Health of the Republic

of Kazakhstan (RCHD), Kazakhstan

190 ISoP18-1308 Hypersensitivity Adverse Drug Reactions In A Portuguese Hospital: 5-Year Retrospective Study Diogo Mendes, AIBILI, DruSER.Net – Drug Safety and Effectiveness Research Network, Portugal

191 ISoP18-1317 Pregnancy Exposure Registry/Birth Defects Surveillance Programme In The Western Cape,

South Africa: A Model For Low- And Middle-Income Countries Emma Kalk, University of Cape Town, South Africa

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192 ISoP18-1211 Analysis Of Adverse Drug Reactions Using Patient Safety Network (Psn) Severity Score Method

Compared To Naranjo Algorithm F. A. Al-Braik, Abu Dhabi Health Services, United Arab Emirates

193 ISoP18-1169 The Impact Of Sex On The Associations Between Ace Inhibitors And Cough And Angioedema:

A Systematic Review And Meta-Analysis Fawaz Alharbi, Universiteit Utrecht, Netherlands

194 ISoP18-1478 Prescribing Issues In The Swiss Hiv Infected Ageing Population Francoise Livio, Service de Pharmacologie clinique, University Hospital Lausanne, Switzerland

195 ISoP18-1464 Importance Of Pharmacovigilance In The Pediatric Population Frederique Rodieux, Geneva University Hospitals, Switzerland

196 ISoP18-1381 Time To Onset Of Adverse Reactions Induced By Artesunate And Amodiaquine

Combination In Drc. Gancia Nsimba, Clinical Pharmacology and PharmacovigilanceUnit, Congo, The Democratic Republic of the

197 ISoP18-1132 Product Confusion Errors: A Pharmacovigilance Analysis Of Vigibase™ And Canada

Vigilance Case Narratives Genaro Castillon, YOLARX Consultants, Canada

198 ISoP18-1312 Safety Of Braf And Mek Inhibitors For Treatment Of Metastatic Melanoma: Disproportionality

Analysis In Vigibase. Ghada Miremont, CHU de Bordeaux, France

199 ISoP18-1380 Reports Of Adverse Events With Levonorgestrel Iud Mirena® In France Before And After

The 2017 Media Intense Coverage Ghada Miremont-Salamé, CHU de Bordeaux, France

200 ISoP18-1399 What Happens To The Striking Cases Presented In The French Pharmacovigilance

Technical Committees? Ghada Miremont-Salamé, Bordeaux Pharmacovigilance center, Bordeaux University, France

201 ISoP18-1166 Safety And Tolerability Of Antipsychotic Drugs In Pediatric Patients: Data From An Ongoing

Active Pharmacovigilance Study In Sicily Giuseppe Cicala, University of Messina, Italy

POSTER LISTING

202 ISoP18-1351 Seizures Following The Administration Of Diphtheria + Pertusis+ Tetanus (Dtp) Containing

Vaccines: A Case Series Gurumurthy Parthasarathi, JSS Academy of Higher Education and Research, India

203 ISoP18-1310 Evaluation Of Pharmacovigilance System In Sudan Using Who Indicators Habab Elkheir, Omdurman Islamic University, University of Science & Technology, Sudan

204 ISoP18-1452 Knowledge And Attitude Of Healthcare Providers About Adverse Drug Reactions And

Pharmacovigilance In Khartoum State Habab Elkheir, Omdurman Islamic University, University of Science & Technology, Sudan

205 ISoP18-1208 Incidence, Prevalence And Risk Factors Of Hypoglycaemia In Diabetes Patients: Systematic

Review And Meta-Analysis Of Observational Studies Hassan Alwafi, University college London, United Kingdom

206 ISoP18-1188 Meningiomas And Progestins: Querying Brest Chru Data Warehouse Hélène Jantzem, CHRU de Brest, France

207 ISoP18-1442 Risk Management Plans: Implementation Of The New Pharmacovigilance Legislation In Mexicoi Hilda Duran, COFEPRIS, Mexico

208 ISoP18-1065 A Methodological Review Of Observational Studies On Central Nervous System Drugs

Use In Pregnancy And Outcomes In Children Ian Wong, University of Hong Kong, Hong Kong

209 ISoP18-1082 Medication Prescribing Practices Of Eating Disorder Consultants For The Treatment Of Young

People With Anorexia Nervosa: A Questionnaire Study Ian Wong, University of Hong Kong, Hong Kong

210 ISoP18-1084 The Efficacy And Safety Of Psychotropic Drug Treatment In Adolescents With Anorexia Nervosa:

A Systematic Review Ian Wong, University of Hong Kong, Hong Kong

211 ISoP18-1389 Safety Profile Of Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir, With Or Without Ribavirin,

In Romania: An Analysis Of Vigibase®/Who Irina Cazacu, University of Medicine and Pharmacy Iuliu Hatieganu, Romania

212 ISoP18-1313 A Model-Based Analysis On Direct Costs Of Adverse Drug Events And Related Cost-Savings

Achievable By Their Prevention In Tuscany, Italy Irma Convertino, University of Pisa, Italy

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213 ISoP18-1314 Pharmacovigilance Software Support For Belgian Community Pharmacists Dieter De Meestere, Association of Pharmacists in Belgium (APB), Belgium

214 ISoP18-1286 Drug-Related Questions From General Practitioners Submitted To A Regional

Pharmacovigilance Centre Jean Louis Montastruc, Centre de PharmacoVigilance, de Pharmacoépidémiologie et d’Informations sur

les Médicaments, Pharmacopôle Midi-Pyrénées, INSERM UMR 1027, CIC INSERM 1436, Centre Hospitalier Universitaire et Faculté de Médecine de l’Université de Toulouse, France

215 ISoP18-1175 Weight Change After Anti-Psychotic Drug Treatment: Long-Term Evidence From

A Retrospective Study Using Electronic Health Records Juan Carlos Bazo-Alvarez, University College London, United Kingdom, Universidad Catolica Los Angeles

de Chimbote (ULADECH-Catolica), Peru

216 ISoP18-1349 Post-Marketing Pharmacovigilance: Checking On Checkpoint-Inhibitors Katharina Geiling, Inselspital Bern, Switzerland

217 ISoP18-1276 What Is Risky About Risk Communications: A Case Study On Dengue Vaccine Kenneth Yu Hartigan-Go, Asian Institute of Management, Philippines

218 ISoP18-1323 The Epidemic Of Opioid Misuse, A Threat For Switzerland? A Pilot Study

At The Geneva University Hospitals Kuntheavy Ing Lorenzini, University Hospitals of Geneva, Switzerland

219 ISoP18-1494 Extra Costs Related To Serious Adverse Drug Reactions In Hospitalized Patients, The Example

Of Long Qt And Agranulocytosis Kuntheavy Ing Lorenzini, University Hospitals of Geneva, Switzerland

220 ISoP18-1300 An Evaluation Of Postmarketing Reports From Industry-Sponsored Programs

In Drug Safety Surveillance Lisa Harinstein, Food and Drug Administration, United States

221 ISoP18-1210 Physician Attitudes Toward Pharmacists Advice On The Appropriateness Of Prescribing Lourdes Garza Ocañas, Universidad Autónoma de Nuevo León, Mexico

POSTER LISTING

222 ISoP18-1163 Ototoxic Adverse Drug Reactions: A Pharmacovigilance Study Using The Italian

Spontaneous Reporting Database Maria Antonietta Barbieri, University of Messina, Italy

223 ISoP18-1120 Pharmacovigilance - Analysis Of Medication Errors Reports Received By Argentine Regulatory

Authority (Anmat) During The Period 2013-2017 Maria Gabriela Papazian, Italian Hospital University of Buenos Aires, Argentina

224 ISoP18-1274 Gynecomastia And Galactorrhea: Unlabeled Adverse Drug Reactions Of Retinoids

Used In Dermatology Marina Atzenhoffer, Hospices Civils de Lyon, France

225 ISoP18-1472 Subclinical Hypothyroidism Associated To Interferon Beta 1A Mehdi Bouhlel, National Centre of Pharmacovigilance, Tunisia

226 ISoP18-1506 Desensitization-Reintroduction Test With Anti-Tuberculosis Drugs Mehdi Bouhlel, National Centre of Pharmacovigilance, Tunisia

227 ISoP18-1155 Pharmacovigilance - Inspection And Audit - Are They The Same Or Different? Meryem Yaman, DeltaPV Ilac Danismanlik Saglik Urun ve Hizmet A.S., Turkey

228 ISoP18-1124 Statistics Trend: Vaccine Reports Regarding Pediatric People In Korea Moonjung Kim, Korea Institute of Drug Safety and Risk Management, Korea, Republic Of

229 ISoP18-1292 Adverse Drug Events Observed In Elderly Patients : Restrospective Study During Six Years Mustapha Bouatia, Mohammed V University-Faculty Of Medicine And Pharmacy- Paediatric Hospital-

Rabat- Morocco, Morocco

230 ISoP18-1076 Profile Of Adverse Events Related To Long-Lasting Insecticide-Treated Nets During Mass

Campaigns In The Democratic Republic Of The Congo Ngamasata Maleluka Therese Mpiempie, National Pharmacovigilance Centre, Congo,

The Democratic Republic of the

231 ISoP18-1480 Adverse Drug Reactions Leading To Emergency Department Admission

In A Tertiary Teaching Hospital Niayesh Mohebbi, Tehran University of Medical Sciences, Iran, Islamic Republic Of

232 ISoP18-1040 Adverse Drug Reactions Leading To Hospitalization In The Elderly Using Prospective

Identification Versus Administrative Coding Nibu Parameswaran Nair, University of Tasmania, Australia

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233 ISoP18-1449 Predictors Of Serious Adverse Events Following Immunization: 1-Year Pharmacovigilance

Study In General Population Niccolò Lombardi, University of Florence, Italy

234 ISoP18-1172 The Impact Of Antihypertensive Drugs On Serum Potassium And Sodium Levels In Patients

Electively Admitted To A Tertiary Hospital Fawaz Alharbi, Universiteit Utrecht, Netherlands

235 ISoP18-1368 Pharmacovigilance Of Herbal Medicines: A Systematic Review And Meta-Analysis Pajaree Mongkhon, Faculty of Pharmaceutical Sciences, Naresuan University, Thailand

236 ISoP18-1193 Safety Profile Of Immune Checkpoint Inhibitors: An Analysis Of Italian Spontaneous

Reporting System Database Paola Maria Cutroneo, University Hospital of Messina, Italy

237 ISoP18-1025 Sjs/Ten Induced By Carbamazepine And Oxcarbazepine: The Analysis Of Drug Injury Relief

Applications In Taiwan Pi-Hui Chao, Taiwan Drug Relief Foundation, Chinese Taipei

238 ISoP18-1134 Paritaprevir / Ritonavir / Ombitasvir And Dasabuvir Related Liver Injury In Real-World Setting:

Data From Taiwan National Adr Reporting System Pi-Hui Chao, Taiwan Drug Relief Foundation, Taiwan National ADR Reporting Center, Chinese Taipei

239 ISoP18-1471 Prevalence Study Of Adverse Effects Associated With The Use Of Medicinal Plants At The

National Institute Of Oncology (Morocco) Rachida Soulaymani, Faculté de Médecine et de Pharmacie, Morocco

240 ISoP18-1051 Adverse Effects Due To Inappropriate Use Of Topical Steroids For Common Dermatological

Disorders: Need For Public Awareness Ratinder Jhaj, All India Institute of Medical Sciences, India

241 ISoP18-1145 Drug-Drug Interactions Between ß Lactam (Amoxicillin/Clavulanic Acid And Imipenem)

And Valproic Acid In The Same Patient Riadh DAGHFOUS, National centre of pharmacovigilance, Tunisia

242 ISoP18-1162 Ecstasy-Induced Hepatitis In A Young Adult Riadh Daghfous, Centre National de Pharmacovigilance, Tunisia

POSTER LISTING

243 ISoP18-1328 Docetaxel Side-Effects Notified To The Tunisian National Centre Of Pharmacovigilance In 2017 Riadh Daghfous, Centre National de Pharmacovigilance, Université Tunis El Manar, Tunisia

244 ISoP18-1347 Palmar Keratoderma Induced By Amoxicillin Riadh Daghfous, Tunisian National Centre of Pharmacovigilance, Tunisia

245 ISoP18-1350 Autoimmune Hepatitis With Atorvastatin? Riadh Daghfous, Tunisian National Centre of Pharmacovigilance, Tunisia

246 ISoP18-1352 Hallucinations Associated With Tetanus Immunization Riadh Daghfous, centre national de pharmacovigilance, Tunisia

247 ISoP18-1375 Drug Rash With Eosinophilia And Systemic Symptoms Syndrome In Pediatric Cases Riadh Daghfous, Centre National de Pharmacovigilance, Tunisia

248 ISoP18-1378 Visual Disturbances Associated With Voriconazole Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

249 ISoP18-1387 Patch- Tests In The Exploration Of Late Toxidermias Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

250 ISoP18-1392 Dress Syndrome Associated With Amphotericin-B In A Kidney Transplant Patient Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

251 ISoP18-1405 Paclitaxel Induced Photosensitivity Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

252 ISoP18-1408 Rhabdomyolysis Associated With The Combined Use Of Levofloxacin And Colchicine

In A Renal Failure Patient With Concurrent Use Of Fenofibrate Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

253 ISoP18-1411 Recurrent Vasculitis Induced By Different Non Steroidal Anti Inflammatory Drugs Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

254 ISoP18-1413 Chemotherapy Induced Hand Foot Syndrome Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

255 ISoP18-1414 Lipoatrophy Complicating Panniculitis Secondary To Treatment By Beta-Interferon Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

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256 ISoP18-1417 Positive Patch-Test To Metronidazole Outside The Sequelae Of Fixed Drug Eruption Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

257 ISoP18-1421 Exceptional Positive Patch Test To Omeprazole To Explore Exanthema Riadh Daghfous, Pharmacovigilance National Center, Tunisia. University Tunis El Manar, Tunisia

258 ISoP18-1423 Agranulocytosis Induced By Voriconazole Riadh Daghfous, centre national de pharmacovigilance, Tunisia

259 ISoP18-1486 Angioedema Induced By Atorvastatin Riadh Daghfous, Tunisian National Centre of Pharmacovigilance, Tunisia

260 ISoP18-1357 Effect Of Ramadan Fasting On Trough Plasma Concentration Of Cyclosporine

In Renal Transplant Patients Riadh Daghfous, Tunisian National Centre of Pharmacovigilance, Tunisia

261 ISoP18-1491 Risk Assessment Of Medication Safety In Pharmacotherapeutic Practice Richard Despott, Ministry for Health, Malta

262 ISoP18-1057 Passive Enhanced Safety Surveillance In Children Receiving Fluenz® Tetra Vaccination

In England During The Early 2017-2018 Influenza Season. Saad Shakir, Drug Safety Research Unit, United Kingdom

263 ISoP18-1061 Utilisation And Safety Of Asenapine In Primary Care In England: Results From A Pass Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

264 ISoP18-1062 Utilisation And Safety Of Asenapine In Secondary Care In The Uk: Results From The

Observational Safety Evaluation Of Asenapine (Observa) Study Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United

265 ISoP18-1063 Risk Of Major And Clinically Relevant Non-Major (Crnm) Bleeding In Patients Prescribed

Rivaroxaban In Primary Care In England. Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

POSTER LISTING

266 ISoP18-1069 Multi-Level Modelling To Investigate Factors Impacting Prescribing Variability Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

267 ISoP18-1077 Incidence Of Major And Clinically-Relevant Non-Major Bleeding In Patients Prescribed

Rivaroxaban: Results From The Rose Study Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

268 ISoP18-1141 Characteristics Of Patients Started On A Reduced Dose Of Rivaroxaban For Atrial

Fibrillation - Results From The Rose Study Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

269 ISoP18-1142 Assessment Of Start Dose In Patients Prescribed Rivaroxaban For Atrial Fibrillation

With Chronic Kidney Disease-Results From The Rose Study Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

270 ISoP18-1143 Distribution Of Cha2ds2-Vasc Scores In Patients With Atrial Fibrillation Treated

With Rivaroxaban In Primary Vs. Secondary Care Settings Saad Shakir, Drug Safety Research Unit, Uni University of Portsmouth, United Kingdom ted Kingdom

271 ISoP18-1149 Impact Analyses Of European Pharmacovigilance Interventions On Public Health Burden Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

272 ISoP18-1150 Changes In Evidence Supporting Post-Marketing Withdrawal Of Marketing

Authorisation In The Eu Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

273 ISoP18-1160 A Cross-Sectional Study Of Product And Batch Traceability For Biologics In Clinical Practice

And Adverse Drug Reaction Reporting In The United Kingdom Saad Shakir, Drug Safety Research Unit (DSRU), United Kingdom

274 ISoP18-1212 Risk Factors Of Major Bleeding In Patients Prescribed Rivaroxaban In Primary Care

In England: Based On A Modified-Prescription Event Monitoring Study Saad Shakir, Drug Safety Research Unit, University of Portsmouth, United Kingdom

275 ISoP18-1167 Hepatic Adverse Drug Reactions Associated With Methylprednisolone: Analysis Of The

French Pharmacovigilance Database Sabrina Pierre, Hospices Civils de Lyon, CHU-Lyon, France

276 ISoP18-1394 Pharmacovigilance In Sudan – An Overview Sarah Hassan, National medicine and poison board, Sudan

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277 ISoP18-1228 Rebound Effect After Discontinuation Of Denosumab – Case Evaluation Of The Regional

Pharmacovigilance Center Bern In Switzerland Sarah Banholzer, Department of General Internal Medicine, Inselspital, Bern University Hospital,

University of Bern, Switzerland

278 ISoP18-1195 Cohort Event Monitoring Of Newest Antidiabetic Agents Using Patient Reported Outcomes Saskia Vorstenbosch, Netherlands Pharmacovigilance Centre Lareb, Netherlands

279 ISoP18-1196 Development And Evaluation Of A Digital Recruitment Method Of Patients For Lareb

Intensive Monitoring Saskia Vorstenbosch, Netherlands Pharmacovigilance Centre Lareb, Netherlands

280 ISoP18-1340 Exceptional Case Of Ecchymosis And Gingivorrhagia Associated With Tocilizumab Sihem El Aidli, centre national de pharmacovigilance, Tunisia

281 ISoP18-1348 Safety Profile Of Quinolone: The Experience Of Tunisian National Centre Of Pharmacovigilance Ines Souilem, centre national de pharmacovigilance, Tunisia

282 ISoP18-1419 Preventing Future Deaths From Medicines: Responses To Coroners’ Concerns Tohfa J Ahmad, West Midlands Centre for Adverse Drug Reactions, United Kingdom

283 ISoP18-1482 Role Of Adverse Drug Reaction In Transfers From Psychiatric Wards To Emergency

Unit In Geneva University Hospitals Vincent Hede, Geneva University Hospitals, Geneva University Hospitals, Switzerland

284 ISoP18-1385 Drug-Related Problems In Hospitalised Patients With Chronic Kidney Disease:

A Systematic Review Wadia Alruqayb, University of Birmingham, United Kingdom

284 ISoP18-1366a National Campaign In An Israeli Chain Of Community-Based Pharmacies To Decrease

The Risks Of Anticoagulants Rina Irene Fermont, ISOP ISRAEL Chapter, IFC Strategic Safety Consulting, Israel

284 ISoP18-1373b Effectiveness, Relationship Between Strains And Factors In Adverse Events Following

Flu Vaccination In Healthcare Workers In Chiang Mai, Thailand Kannika Thiankhanithikun, Faculty of Pharmacy, Chiang Mai University, Thailand

POSTER LISTING

WELCOME RECEPTIONSunday 11 November, 18:00 – 19:30

Venue: Exhibition / Poster Area, CICG

Open to all ISoP 2018 delegates (badge required). Drinks and canapés will be served.

We would like to invite all participants to join us for the official conference reception which will take place at the

exhibition / poster area at the CICG Geneva.

Attendees will have the opportunity to network with friends, colleagues and industry partners in a relaxed atmosphere

whilst enjoying refreshments.

SOCIAL PROGRAMME

CONFERENCE DINNERTuesday 13 November, 19:00 – Midnight

Venue: Hotel Crowne Plaza Geneva Avenue Louis-Casaï 75/77, 1216 Genève

Dress code: Smart casual

How to get there: The venue is accessible with public buses 10 and 53 from Geneva Centre.

Transfer from the ISoP 2018 venue is not provided

The networking dinner will be held at Crowne Plaza Hotel. Attendees will enjoy welcome drinks and a dinner in a casual atmosphere, which will

allow them to network and meet.

A limited number of tickets may be available to purchase onsite - please contact the

registration desk to enquire.

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GENEVAFew European tourist locales can match the charm and number of attractions of Geneva, the second-largest city in Switzerland. It’s no surprise it has won the World Travel Awards title of “the Best European City for Weekend Tours”, a title considered to be the Oscar of the tourism industry.

The inhabitants of Geneva are very cheerful. The city hosts a festive event almost every single day. Even the beginning of a new season is cause for celebration here. For instance, at the beginning of winter, there’s a celebration of Napoleon’s defeat, and the famous L’Escalade, commemorating the city’s victory against Charles Emmanuel I, Duke of Savoy’s troops. In spring, everyone goes to see Geneva’s annual motor show. In summer, the city organises international regattas, the celebration of Geneva’s entrance into the Old Swiss Confederacy, and a world-famous music festival. Rose Festival is one of the major celebrations, lasting for as long as seven days.

For a couple of centuries now, Geneva’s had a tradition to officially announce the coming of spring whenever the first leaf blooms out on the “official” chestnut tree, located outside the canton government’s windows. According to statistics, spring is usually announced in March, although there are exceptions. For instance, in 2002, the chestnut bloomed out on December 29th, and in 2007 as early as October.

Geneva’s English Garden has the world’s largest Flower Clock. Its face is five metres in diameter, and consists of 6,500 live flowers that grow and bloom at different times, making the clock periodically change in colour. The Mayor’s Office of Geneva can be visited by anyone who’s interested. Even groups of tourists can cross the corridors, marvel at the interior and sneak a peek at the meeting rooms, provided they can do so quietly. Geneva is the birthplace of Internet as we know it today.

It is home to the headquarters of the Raëlian Movement. Raëlians are people who believe in the existence of civilization on other planets, and that these civilizations can be contacted through spiritual means.

The city’s botanical garden is more than a hundred years old. Here you’ll find the rarest species of flowers and other plants from around the world.

The locals of Geneva consider the Mont Blanc Bridge, stretching over the River Rhône and Lake Geneva, to be of symbolic value. There are 27 flags of Switzerland’s regions, symbolising the country’s unity.

No matter where you put yourself up – at a hotel, a guesthouse or a camp site – you’ll be given the Geneva Transport Card, which allows you to use public transportation for free, as well as visit most tourist objects at a discount.

Ten per cent of Geneva’s population is employed by an international organisation. The University of Geneva is home to the famous Reformation Wall – a monument that honours the most famous icons of the Protestant Reformation.

One of the oldest architectural structures in Geneva – the Tavel House – has been attracting curious travellers from around the world for over nine centuries. Today, it hosts a history museum with expositions that reflect the local people’s everyday lives from the Middle Ages to the 19th century

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GENEVA - AMAZING EXPERIENCES

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GENEVA’S TOP 10

The Jet D’eau, Geneva’s Landmark

The Old Town And Its Treasures

The Birthplace Of Luxury Watchmaking: From The Flower Clock To The Watchmakers’ Shops

The Reformation Wall - A Monumental Homage

The Palais Des Nations, Symbol Of Geneva, Capital Of Peace

Cern, The World’s Accelerator Of Science

Geneva’s Extraordinary Destiny Captured In Four Museums Uniqu In The World

Carouge & It’s Bohemian Atmosphere

A Certain Art De Vivre In The Quartier Des Bains

A Getaway To Mont-Salève

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Archaeological Site

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Basilica of Notre-Dame

Bâtiment des Forces Motrices (BFM)

Broken Chair & Place des Nations

Brunswick Monument

Calvin Auditory

Cité du Temps

College Calvin

De Châteaubriand Landing Stage

Eaux-Vives Landing Stage

English Garden Landing Stage

Fusterie Church

Geneva Coach Station

Geneva Cornavin CFF Train Station

Geneva Mosque

Geneva University

Genève Aéroport & CFF Train Station

Halles de l’Île

Île Tower and Bridge

International Conference Center Geneva (CICG)

Le Corbusier Building: La Clarté

Madeleine Church

Mairie des Eaux-Vives

Maison Tavel

Molard Landing Stage

Molard Tower

29 Mont-Blanc Landing Stage

Musée Ariana, Swiss Museum for Ceramics & Glass

Musée d’Art et d’Histoire

Musée d’ethnographie de Genève (MEG)

Musée Rath

Museum of Modern & Contemporary Art (Mamco)

National Monument

Natural History Museum of the City of Geneva

Office of the High Commissioner for Human Rights (OHCHR) – Palais Wilson

Old Arsenal and canons

Opera House – Grand Théâtre

Palexpo

Pâquis Baths

Pâquis Landing Stage

Place du Bourg-de-Four

Plaine de Plainpalais

Plainpalais Cemetery

Port Noir Landing Stage

Rousseau Island

Russian Orthodox Church

Saint Germain Church

Saint Gervais Church

Sainte Trinité Church

The Frankenstein Statue

The Sissi Statue

The Smurfs Building

The United Nations High Commissioner for Refugees (UNHCR)

Town Hall

Victoria Hall

World Intellectual Property Organisation (WIPO)

World Meteorological Organisation (OMM)

Shooping Centre

Parc Aventure Geneve

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GENEVA - AMAZING EXPERIENCESPOINTS OF INTEREST Please refer to pages 54 & 55

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Adis Pharmacovigilance EXHIBITOR

Adis, part of Springer Nature, is the industry-leading provider of drug safety information and pharmacovigilance solutions, with more than 6000 customers globally.

Adis Pharmacovigilance offers solutions for regulatory literature monitoring, tailored to your specific needs. Please find more information about Adis Pharmacovigilance below.

Adis journals, newsletters and books include Drug Safety, the official journal of ISoP, and Reactions Weekly, a newsletter with up-to-the-minute summaries of the world’s adverse drug reaction news and case reports.

[email protected] www.adis.com

AB Cube EXHIBITOR

For more than 12 years now, we, AB Cube, are Making Safety Easy. By providing the international healthcare industry with intuitive and evolutive cloud-based vigilance software solutions for management of adverse events, we are THE experts of multivigilance. Our vigilance databases are all validated according to GAMP 5 and FDA 21 CFR part 11.

Always one step ahead, we truly believe in the power of SaaS which allows us to be evolutive, flexible and always compliant with the latest regulation. In November 2017 we were fully E2B (R3) native and so were all our clients.

[email protected] www.ab-cube.com

Celgene SPONSOR

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

[email protected] www.Celgene.com

COMPANY PROFILES

Making Safety Easy

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Eu2p EXHIBITOR

The “European programme in Pharmacovigilance and Pharmacoepidemiology” provides an innovative fully online academic education & training offer in Pharmacovigilance and Pharmacoepidemiology at the worlwide level:

• Master of Science: this curriculum leads to an internationally recognized Master degree

• Certificate courses: choose among 25 different Master level courses to be attended during the Master curriculum calendar and be awarded a recognized academic diploma

• Short Courses: 65 bite-sized courses designed for professionals who want to get an up-to-date, quick and solid knowledge and be certified for audit and Inspections

[email protected] www.eu2p.org

International Society of Pharmacovigilance ORGANIZER

The International Society of Pharmacovigilance (ISoP) is a global professional, independent, not-for-profit society, open to anyone with an interest in the safe and effective use of medicinal products. ISoP aims to foster science, learning and research in pharmacovigilance in all countries.

[email protected] www.isoponline.org

Pfizer SPONSOR

Pfizer is a multinational biopharmaceutical corporation, with global corporate headquarters in New York, New York, United States of America (USA), and global research headquarters in Groton, Connecticut, USA.

Pfizer’s product portfolio includes innovative and generic small molecules, biological therapies, vaccines, and consumer health and nutritional products, which are present in over 180 markets worldwide.

www.pfizer.com/partners/research-and-development

COMPANY PROFILES

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PrimeVigilance EXHIBITOR

PrimeVigilance is a long-standing global services company, established and run by former regulators, providing competent life-cycle management in pharmacovigilance, medical information, regulatory science, pharmacoepidemiology & real world evidence. We have over 500 highly qualified professionals providing expert consulting services, and competitive offshoring and nearshoring solutions which have been successfully inspected on multiple occasions. Our Mission is a world with safer drugs. Our aim is to be the leading dedicated pharmacovigilance and medical information service provider globally

[email protected] www.primevigilance.com

seQure EXHIBITOR

seQure is a niche provider of Pharmacovigilance, Quality Assurance, and Regulatory Compliance solutions. Pharmacovigilance is a core area of expertise where our team has 25+ years of experience. seQure offers a full PhV package: case processing and reporting, safety system and database implementation, QA and compliance for PhV processes with audit support. We also have EU QPPV and Eudravigilance certified staff.

seQure promises impeccable quality and tailored solutions with demonstrated expertise and exceptional understanding of GxP and industry standards and regulations.

[email protected] www.sequrelifesciences.com


Swiss Society of Clinical Pharmacology SPONSOR and Toxicology

The Swiss Society of Clinical Pharmacology and Toxicology (SSCPT) is the scientific society and professional association of clinical pharmacologists and clinical toxicologists in Switzerland. Some of these specialists working in public academic hospitals are in charge of pharmacovigilance activities at the interface with medical practice. The aims of the SSCPT are to foster research related to the application of pharmaceuticals in humans with the prospect to improve the treatment of patients, to promote the area of clinical pharmacology and toxicology with regard to education, exchange of information and practical application, to represent the interests of clinical pharmacologists and clinical toxicologists practising in Switzerland, and to maintain contacts with the corresponding societies abroad

www.swisspharmtox.ch

Takeda SPONSOR

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines.

Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation.

www.takeda.com

COMPANY PROFILES

Uppsala Monitoring Centre EXHIBITOR

Uppsala Monitoring Centre advances the science of pharmacovigilance and inspires patient safety initiatives around the world. An independent, non-profit foundation, we collaborate to build a global patient safety culture.

As a leader in the research and development of new scientific methods, we explore the benefits and risks of medicines to help minimize harm to patients, and offer products and services used by health authorities and life-science companies.

For 40 years, we have provided scientific leadership and operational support to the WHO Programme, expanding global pharmacovigilance.

[email protected] www.who-umc.org

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EXHIBITION

Poster Area

Speaker Preview

Breakout Rooms 3&4

Plenary Hall Room 2

RegistrationDesk

Access to 1st Floor Lunches

EU2PseQure

Springer

ISoP

AB Cube

UMC

PrimeVigilance

Pascoët C

hocolatie

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GVA

Tour

ism

Cash Bar

Catering

Main Entrance


SUPPORTERSWith thanks to the following companies for their unconditional support of the ISoP 2018 Annual Meeting:

NOTES

�� Making Safety Easy

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International Society of Pharmacovigilance ISoP Secretariat Ltd

140 Emmanuel Road London SW12 0HS

United Kingdom

Tel/Fax: +44 (0) 203 256 0027

Email: [email protected] Twitter: @ISoPOnline

www.isoponline.org