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05 Days

30 Speakers

Conference Schedule

Thursday
October

03

07:30

Registrations

08:00 | 📍CMR Theatre

Opening Cermeony

Angela Caro, ISoP, Colombia

Panel
Omar Aimer Co-Chair

Omar Aimer, ISoP, Canada

Omar Aimer Co-Chair

Maribel Salas, Bayer, USA

08:30 |📍CMR Theatre

P1: Current Status of Pharmacovigilance in the Digital Era Around the World

Omar Aimer Co-Chair

Omar Aimer, ISoP, Canada

Panel
Omar Aimer Co-Chair

Pamela Aung-Thin, Health Canada

Omar Aimer Co-Chair

Shanthi Pal, WHO, Switzerland

Patrizia Cavazzoni, US FDA, USA

Omar Aimer Co-Chair

Hisham S. AL Jadhey, SFDA, KSA

Georgy Genov, EMA, Netherlands

10:00

Coffee Break

10:30 |📍CMR Theatre

S1: Artificial Intelligence in Pharmacovigilance from the Industry Perspective.

Omar Aimer Co-Chair

Felix Arellano, Roche, Spain

Omar Aimer Co-Chair

Patrick Caubel, Pfizer, USA

Applicability of Large Language Models (LLM)
to case weighting and taxonomic data extraction in Pharmacovigilance

Omar Aimer Co-Chair

Veronique Kugener, Takeda, USA

Algorithms for causality assessments and predictive signal detection, pro and cons

Omar Aimer Co-Chair

Mariette Boerstoel, BMS, USA

Gen AI in PV: Hallucination or Reality?

Parallel

10:30 |📍CMR Cartier

S2: PV of innovative oncology-targeted therapies and immunotherapy.

Omar Aimer Co-Chair

Yvonne Nanciu, Bayer, Germany

Heather Stein, GSK, USA

Immunotherapy and how It has changed the PV landscape

Omar Aimer Co-Chair

Michael von Forstner, SOBI, Switzerland

Signal Detection and Management for innovative therapies – utilizing RWD and AI

Mircea Ciuca, CSL Behring, Switzerland

An overview of the high unmet need in immunotherapy and beyond from the women´s health perspective

Parallel

10:30 |📍CMR Inrernational

S3: Digital transformation of pharmacovigilance in pregnancy.

Omar Aimer Co-Chair

Ushma Mehta, Cape Town University, South Africa

Miriam C. J. M. Sturkenboom, University Medical Center Utrecht, Netherlands

Towards sustainable global collaboration on medicines safety in pregnancy and lactation? Lessons learned from ConcePTION and CONSIGN.

Omar Aimer Co-Chair

Anick Berard, Université de Montréal, Canada

The Canadian Mother-Child Initiative on Drug Safety in Pregnancy (CAMCCO).

Agnes Kant, Lareb, Netherlands

Lareb Pregnancy Drug Register

Leyla Sahin, US FDA, USA

Updates on FDA’s ongoing development of a framework to optimize the use of post approval pregnancy safety studies

12:00

Lunch

13:30 |📍CMR Theatre

S4: RWE to identify, assess or monitor safety signals in digital era.

Omar Aimer Co-Chair

Gianluca Trifiro, Verona University, Italy

Andrew Bate, GSK, UK

Omar Aimer Co-Chair

Robert Platt, McGill University, Canada

Omar Aimer Co-Chair

Patrice Verpillat, EMA, Netherlands

Parallel

13:30 |📍CMR Cartier

S5: Safety Challenges of New-Generation Therapeutic.

Jeremy Jokinen, BMS, USA

Dr. Dirk Mentzer, MD, Paul-Ehrlich-Institut Germany

Challenges and specific aspect of pharmacovigilance of biomedicines and genetherapy

Kaori Nomura Ph.D, MPH, Teikyo Heisei University, Japan

How Japan’s approach promotes evaluation and vigilance on cell and gene therapy products

Parallel

13:30 |📍CMR Inrernational

S6: Review of policy/ legislation/ regulation that can influence ecopharmacovigilance.

Jerin Jose Cherian, ICMR, India

Dr. Ratinder Jhaj, AIIMS Bhopal, India

Review of policy/ legislation/ regulation that can influence ecopharmacovigilance

Simon Burns, Vial

Artificial intelligence in discovery of environmentally friendly medicines

John Wilkinson, University of York, UK

Artificial intelligence in monitoring environmental levels of pharmaceuticals

15:00

Coffee Break

15:30 |📍CMR Theatre

S7: Collaborative Initiatives for Safer Medications: Unifying Global Pharmacovigilance in the joint mission to prevent errors

Omar Aimer Co-Chair

Alem Zekarias, UMC, Sweden

Brian Edwards, ISoP, UK

Rita K. Jew, ISMP, USA

Artificial intelligence in discovery of environmentally friendly medicines

Parallel

15:30 |📍CMR Cartier

S8: Unleashing the potential of digitalization in empowering patient engagement.

Omar Aimer Co-Chair

Mayada Alkhakany, Boehringer Ingelheim, UAE

Patient engagement SIG: The impact of e-pharmacovigilance on amplifying patient voices

Eva Villalba, Quebec Cancer Coalition, Canada

Patient confidentiality and consent in times of digitalization.

Alison Cave, Healthcare products Regulatory Agency UK

How digital tools can empower patients and create value for all

Parallel

15:30 |📍CMR Inrernational 1

S9: Digital tools in Pharmacovigilance and how they can be improved.

Mark Perrott, Axian, UK

Jean-Christophe Delumeau, Institute of Pharmacovigilance, Canada

Digital Health in Pharmacovigilance

David Lee Scher

Aranka Anema

Artificial Intelligence (AI)-Enabled Approaches to Sex/Gender-based Adverse Event Monitoring

Parallel

15:30 |📍CMR Inrernational 2

S10: L’évaluation clinique des signaux en pharmacovigilance (The clinical evaluation of signals in pharmacovigilance)

Ghita Benabdallah, Centre National de Pharmacovigilance, Morocco

Dr. Houda Sefiani, Anti-poison and Pharmacovigilance Centre, Morocco

La qualité de la notification pour l’analyse en pharmacovigilance

Dr. Marie-Blanche Valnet Rabier, CHU de Besançon, France

Évaluation du signal “Troubles de l’audition associé au vaccin ARN messager”

Dr. Edinam Amavi, WHO, Africa

Processus d’élaboration des consensus des définitions des EIPV graves et des diagnostics différentiels

17:00

End of day
Student Meet & Greet

 

Friday
October

04

08:30 |📍CMR Theatre

P2: Preparedness for the next disaster

Omar Aimer Co-Chair

Rebecca Chandler, CEPI, Sweden

Robert T Chen, Brighton Collaboration, Canada

Tools and guidance to support robust and efficient generation of evidence of safety

Omar Aimer Co-Chair

Jim Buttery, Global Vaccine Data Network

Global collaboration in the conduct of vaccine safety studies 

Danielle Craig, CEPI

Regulatory preparedness in support of generation for robust evidence with the use of vaccines in public health responses.

Alexander Precioso, CEPI

Building pharmacovigilance capacity in vaccine manufacturing partners in the Global South

10:00

Coffee Break

10:30 |📍CMR Theatre

S11: Opioids

Rania Mouchantaf

Rania Mouchantaf, Health Canada

Introduction

Eilaine Morrato

Mohammed Adinoyi Usman

African Perspective

Luis Pinheiro, EMA, Portugal

Parallel

10:30 |📍CMR Cartier

S12: PV Training Needs and PV Professional Certification.

Jan Petracek, Ivigee, Czech

Magnus Ekelo, UMC, Sweden

Training Needs

Rachida Soulaymani/Ghita, Centre National de Pharmacovigilance, Morocco

Morocco

Veronique Kugener, Takeda, USA

Am2P

Omar Aimer, InnoVigilance, Canada

Canadian Training

Parallel

10:30 |📍CMR Inrernational

S13: CIOMS Guidelines on Benefit-Risk, RWE, and Artificial Intelligence.

Niklas Norén

Niklas Noren, UMC, Sweden

Ana Claudia Ianos, Pfizer, USA

Real-World Data and Real-World Evidence in Regulatory Decision Making

Juhaeri Juhaeri, Sanofi, USA

Benefit-Risk Balance for Medicinal Products

Taxiarchis Botsis, Johns Hopkins University USA

Artificial Intelligence in Pharmacovigilance

12:00

Lunch

13:30 |📍CMR Theatre

General Assembly

Angela Caro, ISoP, Colombia

Executive Committee Presentation
SIGs Update
Chapters Update
15:00

Coffee Break

15:30 |📍CMR Theatre

S14: Principles and examples of registries and alternatives using artificial intelligence in pharmacovigilance.

Omar Aimer Co-Chair

Ushma Mehta, Cape Town University, South Africa

Pregnancy registry in Africa

Luis Pinheiro, Portugal

Miriam C.J.M.Sturkenboom, University of Utrecht, Netherlands

Parallel

15:30 |📍CMR Cartier

S15: Pharmacogenomics in PV.

Bruce Carleton

Bruce Carleton, University of British Columbia, Canada

Pharmacogenomic research using pharmacovigilance data: finding solutions to drug safety problems

Qun-Ying Yue, UMC, Sweden

Pharmacogenomics in Pharmacovigilance: methodology from signal detection to medicinal products labeling

Jacques Turgeon, GalenusRx, USA

Pre-emptive pharmacovigilance in the context of pharmacogenetics using biosimulations and real-world polypharmacy drug claims data from large populations

Parallel

15:30 |📍CMR Inrernational 1

S15: Automation in PV.

Francesco Salvo, Université de Bordeaux, France

Intelligent automation and artificial Intelligence in PV: strengths and limits

Ryan Walker, Oxford University, UK

Automation in LMIC

Alison Cave, MHRA, UK

Tina Bostic, Novavax, USA

Parallel

15:30 |📍CMR Inrernational 2

S16: Avances y retos en Farmacovigilancia en la region de Latino América (Advances and Challenges in Pharmacovigilance in the Latin American Region)

Liliana Vargas, MOH Mexico

  • Pharmacogenomics today: understanding the application in drug safety evaluation
  • Risk management plans
  • Strategies to engage patients in patient safety
17:00

End of day
Conference Dinner

 

Saturday
October

05

08:30 |📍CMR Theatre

P3: Advancing Safety with New Technologies in Medical Devices and Combination Products

Omar Aimer Co-Chair

Marina Malikova, Boston University, USA

Jeffrey Siracuse, Boston University, USA

Managing risks and safety in clinical trials involving special populations with medical devices.

Juan Daccach, Merz, USA

The role of physicians in risk management for medical devices

Marina Malikova, Boston University, USA

Risk-based quality and safety management in clinical trials with medical devices as combination products

09:40

Coffee Break

10:10 |📍CMR Theatre

P4: The Future of Pharmacovigilance. Challenges and opportunities in a fast-changing environment from different angles

Omar Aimer Co-Chair

Maribel Salass, Bayer, USA

Monica Muñoz

Monica Munoz, US FDA, USA

US FDA perspective

Omar Aimer Co-Chair

Patrick Caubel, Pfizer, USA

Drug development- Pharma industry perspective

Shanti Pal, WHO, Switzerland

WHO perspective

Alex Dodoo, Africa

PV in African region perspective

Luis Pinheiro, EMA, Portugal

EMA perspective

Peter Hjelmström, UMC, Sweden

Global standardization for safer use of medicines and vaccines

11:10 |📍CMR Theatre

Special Session: Beje Wiholm lecture

Brian Edwards, ISoP, UK

The system to optimise use of medicines and devices ultimately depends on human performance

12:00 |📍CMR Theatre

Closing Ceremony

Angela Caro, ISoP, Colombia

Closing remarks

Monica Tarapues, ISoP, Equador

Award winners

Omar Aimer Co-Chair

Omar Aimer, ISoP, Canada

Thank you notes

Maribel Salas, ISoP, USA

Thank you notes

Hadir Rostom, ISoP, Egypt

Presentation of ISoP 2025

13:00

Lunch
End of the Conference

 

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