pre conference course 1 · active pharmacovigilance fundamental aspects: • de"nitions. •...

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Pre Conference Course 1 Medication errors and human factors.* ARRANGED BY ANGELA CARO AND BRIAN EDWARDS *

08:00 - 08:30

10:30 - 11:00

08:30 - 09:30

09:30 - 10:30

Registration.

Coffee Break.

Brian Edwards

Thamer AlShammary

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

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

11:00 - 12:00 Good case management with advice about better coding and classification.María Mercedes Córdoba

12:00 - 13:0013:00 - 13:45

13:45 - 14:15Carlos Aceves González / Yordan Rodríguez

Ghita Benabdallah / Houda Sefiani

Lunch Break.Practical implications of Human Factors (The place of Ergonomic Checkpoints).

Medication error management from detection to risk minimization actions.

14:15 - 15:15 Sentinel events and analysis based on human factors and Metacognition (Workshop).Angela Caro / Ghita Benabdallah

15:15 - 15:45 Coffee Break.15:45 - 16:15 Interactive case study: Injecting oral medicine intravenously. (Workshop)

Brian Edwards / Angela Caro16:15 - 16:45 Hospital experience.

Helaine Capucho16:45 - 17:15 Wrap-up and Conclusions.

Brian Edwards

Welcome Cocktail and cultural show.18:00 - 20:30

Room Huila

PRE-CONFERENCEPROGRAMME

Saturday October 26th

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PRE-CONFERENCEPROGRAMMESaturday October 26th

08:00 - 08:30

11:00 - 11:30

08:30 - 09:30

09:30 - 10:15

Registration.

Coffee Break.

Ulrich Hagemann / Pedro Lima

Deirdre McCarthy / Katarina Illic

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

Industry perspective Global and local.

10:15 - 11:00 Methods in active pharmacovigilance:• Description • ExamplesNatalia Kocankova / Ulrich Hagemann

11:30 - 12:30

12:30 - 13:30Wendy Camelo

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

Lunch Break.13:30 - 14:00 Interactive case.

Pedro Lima

15:30 - 16:00 Coffee Break.

14:00 - 15:30

16:45 - 17:15

Practical workshop in active Pharmacovigilance.

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

Wendy Camelo

Deirdre McCarthy / Natalia Kocankova

16:00 - 16:45 Hospital Active Pharmacovigilance.Liliana Vargas

Room Cauca


Pre Conference Course 2Active surveillance in pharmacovigilance including

pharmacoepidemiology tools.* ARRANGED BY WENDY CAMELO *

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PRE-CONFERENCEPROGRAMME

Saturday October 26th

08:00 - 08:30

10:30 - 11:00

08:30 - 09:30

09:30 - 10:30

Registration.

Coffee Break.

Gloria Giraldo / Mariano Madurga Sanz

Gloria Giraldo

Global regulations on PV for biological and biotechnological products (FDA, HC, EMA).Strategies and actions taken as a result of the regulations. Industry problems to apply regulations.

RMP and biological and biotechnological controversies: utility in practice, in the clinic, in theregulatory agencies.

12:30 - 13:30

11:00 - 12:00

12:00 - 12:30Stephan Jarpa / Gillian Winstanley

Lunch Break.

Practical aspects of Case Management Plan focusing on naming and traceability.

Discussion panel.

13:30 - 14:30

14:30 - 15:15

15:15 - 16:00

Interchangeability and the role of pharmacovigilance. “Switch” studies.

Interactive case.

Workshop feedback.

Marco Tuccori

Marco Tuccori / Santiago Schiaffino / Mariano Madurga Sanz / Gloria Giraldo

All16:00 - 16:30 Coffee Break.16:30 - 17:15

17:15 - 17:40

Patient role and impact in public health.

Conclusions and wrap-up.Stephan Jarpa

Gloria Giraldo / Mariano Madurga Sanz

Room Tolima


Pre Conference Course 3 Biological and biotechnological product safety.* ARRANGED BY GLORIA GIRALDO AND MARIANO MADURGA *

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07:30 - 08:30

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 role in Pharmacovigilance.

Importance of Human factors in pharmacovigilance.

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) talk: assessing the impact of pharmacovigilance and interventions to minimise risk.

Coffe Break/Poster Viewing

Lunch for Delegates*Reserved area for Special Interest Groups (SIG) Meetings*

OPENING SESSION.Sten Olsson (President of ISoP)Brian Edwards (UK) Chair ISoP 2019Angela Caro (Colombia) Co Chair ISoP 2019 Claudia Vaca (Colombia) National University of ColombiaShanti Pal (WHO)

Helen Haskell / Evangelina Vásquez

Carlos Aceves González / Yordan Rodríguez

Agnes Kant

Room El Dorado

Sunday October 27thCONFERENCE PROGRAMME

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14:00 - 14:30 14:00 - 14:20

14:30 - 14:50 14:20 - 14:40

14:50 - 15:10

15:10 - 15:30

Parallel session ARoom El Dorado 1 Room El Dorado 2

Current approaches to traditional chinesemedicines.

Theater in indigenous populations andPharmacovigilance. (Teleconference)

Cannabis products: pharmacological andpharmacovigilance challenges.

Vigilance of cannabis products in Canada.

Abstract oral presentation:#52 - Current status and thoughts about heart injury

related to Traditional Chinese Medicine.

Abstracts oral presentation: #87 - Systematic Instructions for Haematological

Monitoring in Summary of Product Characteristics– what constitutes good practice.

#19 - MedSafetyWeek:joining forces on social media to raise

ADR awareness.

Herbal and traditional medicines.

Safety issue communication requirements.

Open Discussion.

Importance of Communication inPharmacovigilance.

Parallel session B

15:30 - 16:00 Coffe Break/Poster Viewing

Coordinator: Jo Barnes

Katarina Illic

Stephanie Jack

Jia-bo Wang

L.Zhang, Y.Wen, J.Huang

Coordinator: Ulrich Hagemann

Juan Miguel Palacios

Gillian Winstanley

C.Anton, J.Coleman, R.Ferner, T.New, S.Pontefract

F.Santoro, G.Norgela

14:40 - 14:55

14:55 - 15:10

15:10 - 15:30


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Room El Dorado 1 Room El Dorado 2

16:00 - 16:30 16:00 - 16:30

17:05 - 17:20 17:05 - 17:20

Moving vaccine pharmacovigilance into the 21st century.

Abstract oral presentation:#91 - Vaccines safety in children and in general

population: a pharmacovigilance study onadverse events following immunization in Italy.

Transcelerate projects in PV.

Abstract oral presentation:#143 - Creation of an Innovation Function in

Pharmacovigilance.

What’s new from North America andEuropean Union?

Safe use of Vaccines.

Chair: Gloria Giraldo

Jose Vega

Jose Vega / Fabio Lievano / Felix Arellano

S.Beauchamp, N.Tetarenko, S.Desai, R.Mockute,D.Abatemarco, B.Assuncao, M.Widdowson, E.Mingle

Rebecca Chandler

Alex Dodoo

F.Lippi, G.Crescioli, M. Del Lungo, M.Rossi, C.Azzari,R.Bonaiuti, M.Levi, P.Bonanni, N.Lombardi, S.Ricci,

A.Bettiol, L.Giovannetti, C.Ravaldi, M.Parrilli, V.Borsi

Chair: Sten Olsson

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

Parallel session C Parallel session D

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08:30 - 09:00 08:30 - 09:15

09:00 - 10:00 09:15 - 10:00

Parallel session E

Abstract oral presentation:

Risk management and Signal detection.

PV Education experience of LATAM. Symposium.Digital approaches to risk minimisation.

Biotechnological and biosimilars drugs.

Challenges in Latin-American Pharmacovigilance.

Parallel session F

10:00 -10:30 Coffe Break/Poster Viewing

Chair: Jean-Christophe Delumeau Chairs: Luis Alesso

Raquel Herrera / Jorge Machado / Adalton Ribeiro

Chair: Marco TuccoriFabio Lievano / Gillian Winstanley / Pedro Lima

Mark Perrott

H.Sefiani, I.Talibi, G.Benabdallah, L.Alj , A.Tebaa,R.Soulaymani Bencheikh

M.Forstner

P.Ryan, R.Chandler

#14 - Application of Qualitative method to detect signals and manage alerts in pharmacovigilance: Moroccan

experience.

#29 - Digital tools for the communication of riskminimization measures for medicines.

#5 - Integrated use of spontaneous reports of adversedrug reactions and observational healthcare data in

signal assessment.

Discussion.

Room El Dorado 1 Room El Dorado 2Monday October 28th

CONFERENCE PROGRAMME

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Monday October 28thCONFERENCE PROGRAMME

11:45 - 12:30

Parallel session G

Expert Panel discussion on women’s medicines.

Abstract oral presentation:#147 - How the Romanian women perceive the

advantages and risks of the contraceptives?

Parallel session H

10:30 - 10:35

10:35 - 11:10

11:10 - 11:30

11:30 - 11:45

10:30 - 11:30 Welcome and introduction.

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

(Teleconference).

Mifespristone introduction experience.

Medicines for Reproductive Health:International and local perspectives for

Latin American Women.

Panel.

Desafios de la farmacovigilancia “Spanishcommunity” Spain, Latam, USA and EU.

Chair: Mira Harrison-Woolrych

Mira Harrison-Woolrych

Sam Rowlands

Ulrich Hagemann / Raquel Herrera /Katarina Illic / Juan Carlos Vargas

Juan Carlos Vargas / Fidel Ramírez / Andres Reyes

A.Butuca, L.Rust, C.Morgovan, I.Lupse, A.Juncan,L.Vonica Tincu, F.Gligor, A.Muntean, S.Ghibu

Chair: Angela Caro / Mariano Marduga

OD.Arias Romero

S.Schiaffino, L.Rodrigues, R.Moraes, P.Santos,C.Travassos

Evangelina Vasquez (Patient vision), Pilar Lagos (Regulatory Agency)

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

#37 - Impact and Characterization of the DrugRelated Problems Reported by Polymedicated Inpatients

with Prolonged Stays.

#46 - Initiative to increase PV awareness and supportaccess to medication for the patient.

Room El Dorado 1 Room El Dorado 2* Conference language: Spanish with translation to English

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12:30 - 13:30 Lunch for Delegates*Reserved area for Chapter members Meetings*

13:30 - 14:45 ISoP GENERAL ASSEMBLY

1. Welcome and approval of Agenda and Minutes General Assembly Geneva.

3. Financial position and membership fee for 2020.

5. ISoP Advisory Board Elections 2019.

2. Fellowship awards.

4. Highlights since Geneva (governance, partnership, meetings, chapters and SIGs).

6. Planning for the future.

7. Any other business.

Room El Dorado 2


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

14:45 - 15:30 14:45 - 15:30

Parallel session I

Experience of Brazil.

Experience of Mexico.

Latin American perspective.

Asian perspective.

Industry Contribution to the developmentof effective global and national

pharmacovigilance systems.

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

Parallel session J

Chair: Katarina Illic

Helaine Capucho

Liliana Vargas Neri

T.M. Alshammari, N.Alghaythi, A.Alshammari,A.Altebainawi

C.A.Calderon Ospina, M.Galvez Bermudez, C.Lopez Cabra, F.Aristizabal Gutierrez, P.Laissue Hormaza, D.Fonseca

Mendoza, J.Rodriguez

Gillian Winstanley

Jean-Christophe Delemeau

K.Pisani, V.Hernandez

Chair: Marco Tuccori

#59 - Patient counselling practice among healthcareprofessionals in Saudi Arabia: its impact on patient safety.

#129 - Differences in Pharmacovigilance RegulatoryRequirements in Latin America countries (LATAM).

Discussion.#110 - Medication errors and genetic factors as

possible causes of therapeutic failures andadverse drug reactions in a group of

Colombian epilepsy patients.

16:00 - 16:20 Coffe Break/Poster Viewing

Room El Dorado 1 Room El Dorado 2

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16: 20 - 17:00

16: 20 - 17:00

Chapters Session

Africa Chapter

North American Chapter

Middle East Chapter

Latest news about ISoP Chapters.Chair: Brian Edwards

Sten Olsson

Veronique Kugener

Thamer AlShammaryItaly ChapterMarco Tuccori

South East Europe Chapter

Pacific Rim Chapter

Indonesia Chapter

Latam Chapter

Katarina Illic

Mira Harrison-Woolrych

Jean-Christophe Delumeau

Raquel Herrera

17:00 - 17:40

Special Interest Groups Session

SIGs Risk Communication, Medication Errors, Women’s Medicines Group Risk 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 McCarthy

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

20:00 - 24:00 Gala Dinner.

17:45 - 18:10 Movie “Going Further Together” . A film about global medicines safety from Uppsala Monitoring Centre – UMC.

Room El Dorado

Room El Dorado

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09:00 - 09:30

10:00 - 10:40

11:00 - 11:45

14:00

10:40 - 11:00

12:30 - 14:00

09:30 - 10:00

Strengthening the capacity for signal detection and management for Pharmacovigilance national centres. (Uppsala Monitoring Centre).

Smart Safety Surveillance: what, why and how.

End of the meeting.

Coffee Break

Lunch

“Bengt Erik Wiholm” Lecture.Which are the new opportunities for new generations?Mariano Madurga Sanz

Birgitta Grundmark

Shanti Pal

Tuesday October 29thCONFERENCE PROGRAMME

Room El Dorado

CIOMS Update about hepatoxicity and drug induced liver injury (DILI).Chair: Hervé Le LouëtSpeaker: Alexandre Olry

11:45 - 12:00

12:00 - 12:30

Posters and abstracts awards.

Host presentation for ISoP 2020 in Oman.

Raquel Herrera

Thamer AlShammary / Mayada Alkhakany

pre conference course 1 · active pharmacovigilance fundamental aspects: • de"nitions. •...

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