Saturday October 26thPre Conference Course 1

Medication errors and human factors

- Arranged by Angela Caro and Brian Edwards -

08:00 - 08:30

08:30 - 09:30

09:30 - 10:30

11:00 - 12:00

13:00 - 13:45

Registration.

SIG Group presentation: Set the scene - medication errors terms and definitions, epidemiology.

Risk factors for medication errors: what works? Current medication errorsstrategies (ISMP, WHO, ASHP).

Good case management with advice about better coding and classification.

Extrinsic Human Factors (Working environment, Fatigue, Stress, Blame culture ) Relevance for team working, culture change, leadership.

Brian Edwards (UK)

Thamer Al-Shammary / Mayada Alkhakany

Katarina Kralova / Neslihan Mendi (Support)

Carlos Aceves González / Yordan Rodríguez

10:30 - 11:00

12:00 - 13:00

Coffee Break

Lunch Break

Saturday October 26th

Medication errors and human factors- Arranged by Angela Caro and Brian Edwards -

Pre Conference Course 1

13:45 - 14:15

14:15 - 15:15

Medication error management from detection to risk minimization actions.

Sentinel events and analysis based on intrinsic human factors and Metacognition (Workshop).

Ghita Benabdallah / Houda Sefiani

Angela Caro / Ghita Benabdallah

15:45 - 16:15

16:15 - 16:45

16:45 - 17:15

Interactive case study: Injecting oral medicine intravenously. (Workshop)

Hospital experience.

Wrap-up and Conclusions.

All

Helaine Capucho

Brian Edwards (UK)

15:15 - 15:45 Coffee Break

Saturday October 26thPre Conference Course 2

08:00 - 08:30

08:30 - 09:30

09:30 - 10:00

10:00 - 10:45

11:15 - 12:15

Registration.

Active pharmacovigilance fundamental aspects:• Definitions• Regulatory aspects: FDA,EMA and Latam

Methods in active pharmacovigilance:• Description• Examples

Methods in Pharmacoepidemiology:What do regulatory agencies do with PV Databases?Do we have a room for improvement?

Industry perspective Global and local.

10:45 - 11:15

12:15 - 13:15

Coffee Break

Lunch Break

Pedro Lima / Natalia Kocankova

Deirdre MacCarthy / Katarina Ilic

Natalia Kocankova

Wendy Camelo

Active surveillance in pharmacovigilance including pharmacoepidemiology tools- Arranged by Natalia Kovantova, Prime Vigilance -

Saturday October 26thPre Conference Course 2

13:45 - 15:15

16:45 - 17:15

13:15 - 13:45

15:45 - 16:15

16:15 - 16:45

Practical workshop.The workshop should allow participants to use the different methods described to enhance their familiarity with them.

Wrap-up and Conclusions (LATAM Implications, perspectives and new tools).

Interactive case.

Hospital setting: Active Pharmacovigilance.

A successful case study of active surveillance.

15:15 - 15:45 Coffee Break

Pedro Lima

Liliana Vargas

Carlos Maldonado

Wendy Camelo and All

Deirdre MacCarthy / Natalia Kocancova

Active surveillance in pharmacovigilance including pharmacoepidemiology tools- Arranged by Natalia Kovantova, Prime Vigilance -

Saturday October 26thPre Conference Course 3Biological and biotechnological

product safety- Arranged by -08:00 - 08:30

08:30 - 09:30

09:30 - 10:30

11:00 - 11:30

11:30 - 13:00

Registration.

Global regulations for PV of biological and biotechnological(FDA, Health Canada, EMA, ICH, WHO).Strategies and actions taken as a result of the regulations.Audit findings and improvement opportunities.Industry approaches to effectively apply regulations.

* RMP and biological and biotechnological Controversies: utility in practice, in the clinic, in the regulatory agencies. * The impact of different reference models, FDA vs EMA and WHO.* Explain basis of workshop later on the agenda.

Importance of naming and identifying precisely and accurately suspect biological product of the adverse reaction and its essential place in enabling product safety and quality.

Traceability: What is this and why is it important for monitoring patient safety, effectiveness, quality of life, adherence, etc. What are the systematic challengesand how can we address these barriers?

Gloria Giraldo / Mariano Madurga Sanz

Gloria Giraldo / Carlos Maldonado

Fabio Lievano / Gillian Winstanley / Felix Arellano

Fabio Lievano / Gillian Winstanley / Felix Arellano

10:30 - 11:00 Coffee Break

Saturday October 26thPre Conference Course 3

Biological and biotechnologicalproduct safety- Arranged by -

14:00 - 15:00

15:30 - 16:30

Interchangeability and the role of pharmacovigilance - actual experiences and how canthis be measured?: How as a patient am I involved in the decision on interchangeability?Switch studies.

Event researcher workshop:How do I proceed from the recognition of an adverse event to implementing a risk minimisation measure?How can we assess impact on the patient and the public health? Example Infliximab.

Marco Tuccori

Carlos Maldonado and All

13:00 - 14:00 Lunch Break

15:00 - 15:30 Interactive case.Carlos Maldonado

16:30 - 17:00 Coffee Break

17:30 - 17:40

17:00 - 17:30

Conclusions Workshop.

Patient role and impact public health.Stephan Jarpa

Gloria Giraldo / Mariano Madurga Sanz / Carlos Maldonado

Sunday October 27th

08:00 - 09:00

09:30 - 10:30

11:00 - 11:45

11:45 - 12:30

10:30 - 11:00

12:30 - 14:00

08:30 - 09:30

Registration.

Patients in Pharmacovigilance.

Importance of Human factors in pharmacovigilance.

ENCEPP talk: assessing the impact of pharmacovigilance and interventions to minimise risk.

Break

Lunch

OPENING SESSION. Sten Olsson (President of ISoP)Brian Edwards (UK) Chair ISoP 2019Angela Caro (Colombia) Co Chair ISoP 2019Prof. Carlos Maldonado (Colombia) Claudia Vaca (Colombia)Marie Lindquist (UMC)Shanti Pal (WHO)

Helen Haskell / Evangelina Vasquez

Carlos Aceves González / Yordan Rodríguez

Agnes Kant

Sunday October 27th

14:00 - 14:30

14:30 - 14:50

14:50 - 15:10

15:10 - 15:30

Parallel session A

Dr. Wang presentation. Theatre in indigenous populations and PV.

Cannabis Talk (Regulatory point of view)

Cannabis Talk (Clinical and safe Use)

Abstract oral presentationCurrent status and thoughts about heart injury related to Traditional Chinese Medicine Drugs.

Abstract oral presentationSystematic Instructions for Haematological

Monitoring in Summary of ProductCharacteristics – what constitutes good practice

PLUS BACK UP

MedSafetyWeek:joining forces on social media to raise

ADR awareness.

Herbal and traditional medicines SIG.

Safety issue communication requirements.

Open Discussion.

Importance of Communication inPharmacovigilance.

Parallel session B

15:30 - 16:00 Break

Coordinator: Jo Barnes

Stephanie Jack (Health Canada)

TBD

Coordinator: Priya Bahri

Juan Miguel Palacios TC

Gillian Winstanley

16:00 - 16:30

17:05 - 17:20

Feedback on UMC seminar about vaccine safety.

Abstract:Vaccines safety in children and in generalpopulation: a pharmacovigilance study on

adverse events following immunization in Italy.

Transcelerate projects in PV.

Abstract:Creation of an Innovation Function in

Pharmacovigilance.

What’s new from North America and EU? Safe use of Vaccines.

Sunday October 27th

Chair: Gloria Giraldo

Jose Vega

Jose Vega, Fabio Lievano, Felix Arellano,Gayatri Jayaraman

(Celgene)

Rebecca Chandler

Alex Dodoo

Chair: Houda Langar

16:30 - 17:05Panel Discussion. Progess with malaria vaccine.

17:30 - 18:00 Musical show at the hotel.

Parallel session C Parallel session D

Monday October 28th

08:30 - 09:00

09:00 - 10:00

Parallel session E

Abstract oral presentation.

Risk management and Signal detection.

PV Education experince of LATAM.Digital approaches to risk minimisation.

Symposium.

Biotechnological and biosimilars drugs.

Challenges in LatinamericanPharmacovigilance.

Parallel session F

10:00 -10:30 Break

Chair: Jean-Christophe Delumeau Chairs: Luis Alesso / Raquel Herrera

Raquel Herrera

Jorge Machado, Javier Uribe, Raquel Herreraand Luis Alesso

Leandro Castillo / Gillian WinstanleyPedro Lima

Mark Perrott

A comparison of cardiology medical devices recall in the United States and the European

Union for 2018.

Application of Qualitative method to detect signals and manage alerts in pharmacovigilance:

Moroccan experience.

Digital tools for the communication of riskminimization measures for medicines.

Discussion.

Monday October 28th

11:45 - 12:30

Parallel session G

Expert Panel discussion on women’s medicines.

Abstract oral presentation.How the Romanian women perceive the

advantages and risks of the contraceptives?

Parallel session H

10:30 - 11:45 Welcome and introduction.

International overview of long-acting reversible contraceptives (LARCs) for women.

Teleconference.

Mifespristone introduction experience.

Women’s Health (SIG).

Panel.

Desafios de la farmacovigilancia “Spanish community” España, Latam y SC in USA.Chair: Mira Harrison-Woolrych

Dr Mira Harrison-Woolrych

Prof Sam Rowlands

Speakers and Ulrich Hagemann

PROFAMILIA: Juan Carlos Vargas,Fidel Ramírez, Andres Reyes

Chair: Angela Caro / Mariano Marduga

Evangelina Vasquez (Patient vision), Pilar Lagos (Regulatory)Elki Sollenbring (UMC)

Stephan Jarpa (Public Health and Pharma Industry)Wendy Camelo (Pharmacoepidemiology)

Claudia Vaca (WHO)Liliana Vargas Neri (Hospital Vision)

Open panel with public.

Abstracts Oral presentation.

11:30 - 12:00

12:00 - 12:30

Impact and Characterization of the DrugRelated Problems Reported by Polymedicated

Inpatients with Prolonged Stays.

Initiative to increase PV awareness and support access to medication for the patient.

12:30 - 13:30 Lunch

13:30 - 14:45 ISoP GENERAL ASSEMBLY.

15:30 - 16:00Abstracts presentation. Abstracts presentation.

14:45 - 15:30

Parallel session I

Brazil:

Mexico:

Africa and Middle East:

Latin America perspective:

Asia:

Impact in real life: are we making a difference? (Industry vision)

Impact in real life: are we making a difference? (Hospital/community vision)

Parallel session J

Chair: Katarina Ilic

Helaine Capucho

Liliana Vargas Neri

Esteban Herrero Martínez

Gillian Winstanley

Jean-Christophe Delemeau

Chair: Marco Tuccori

Monday October 28th

The impact of Pharmacovigilance in Patient Support Programs for Orphan Diseases,

experience in Colombia.

Patient counseling practice among healthcare professionals in Saudi Arabia: its impact on

patient safety.

Differences in Pharmacovigilance RegulatoryRequirements in Latin America countries

(LATAM)

Medication errors and genetic factors aspossible causes of therapeutic failures and

adverse drug reactions in a group of Colombian epilepsy patients.

16: 20 - 17:00

Chapters Session

Africa Chapter.

Middle East:

Latest news about ISoP Chapters.Chair: Brian Edwards

Sten Olsson

Thamer AlShammary

Monday October 28th

16:00 - 16:20 Coffee

Italy Chapter: Marco Tuccori

South East Europe:

Pacific Rim Chapter:

Indonesia:

Katarina Ilic

Mira Harrison-Woolrych

Jean-Christophe Delumeau

17:00 - 17:40

Special Interest Group Session

SIGs Risk Communication, Medication Errors, Women’s Medicines GroupRisk Minimisation Methods for Asian countries, Herbal and Traditional Medicines,

PV Professional Qualification Framework, Medical Devices.

What SIGs exist, why and how can I join a SIG?Chair: Deirdre Mc Carthy

20:00 - 24:00 Gala Dinner.

19:00 - 19:30 Transportation to the Gala Dinner venue.

Monday October 28th

Tuesday October 29th

09:00 - 09:30

10:00 - 10:40

11:00 - 11:45

10:40 - 11:00

12:30 - 14:00

09:30 - 10:00

UMC project about signal detection: Strengthening the capacity for signal detection and management for national centres.

Reduction of medication error: the WHO challenge advances (WHO).

CIOMS Update about hepatoxicity and DILI - Lecture.

Break

Lunch

Bengt Erik Wiholm Lecture.Which are the new opportunities for new generations?

11:45 - 12:30 Posters and abstracts awards. Host presentation for ISOP 2020 in Oman

Mariano Madurga Sanz

Niklas Noren

Shanti Pal

Hervé Le Louët

Thamer M. AlShammary