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05 Days
115 Speakers
Conference Schedule
Thursday
October
03
07:30
Registrations
08:00 | 📍CMR Theatre Symposia
Opening Ceremony
Angela Caro, ISoP President, Colombia
.
Omar Aimer, LOC Chair, Canada
Maribel Salas, SC Chair, USA
08:30 |📍CMR Theatre Symposia
P1: Current Status of Pharmacovigilance in the Digital Era Around the World
Omar Aimer, NASoP President, Canada
Panel
Kelly Robinson, Health Canada
Shanthi Pal, WHO, Switzerland
Narayan Nair, US FDA, USA
Hisham S. AL Jadhey, SFDA, KSA
Thomas Stammschulte, SwissMedic
Alison Cave, MHRA, United Kingdom
Luis Pinheiro, EMA, Netherlands
10:00
Coffee Break
10:30 |📍CMR Theatre Symposia
S1: Artificial Intelligence in Pharmacovigilance from the Industry Perspective.
Felix Arellano, Roche, Spain
Patrick Caubel, Pfizer, USA
Applicability of Large Language Models (LLM)
to case weighting and taxonomic data extraction in Pharmacovigilance
Veronique Kugener, Takeda, USA
Algorithms for causality assessments and predictive signal detection, pro and cons
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.
Yvonne Nanciu, Bayer, Germany
Christine Dabrowski, GSK, USA
Immunotherapy and how It has changed the PV landscape
Michael von Forstner, Mesama, Switzerland
Signal Detection and Management for innovative therapies – utilizing RWD and AI
Mircea Ciuca, Organon, Switzerland
An overview of the high unmet need in immunotherapy and beyond from the women´s health perspective
Oral presentations
Safety profile of Immune Checkpoint Inhibitors: an Updated Analysis of the Italian Spontaneous Reporting System Database. Paola Maria Cutroneo
Literature analysis on immune checkpoint inhibitors-related hemophagocytic lymphohistiocytosis. Shenao Jing
Parallel
10:30 |📍CMR International
S3: Digital transformation of pharmacovigilance in pregnancy.
Ushma Mehta, Cape Town University, South Africa
Ushma Mehta, Cape Town University, South Africa
Innovations in Pregnancy PV
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.
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
Oral presentation
Assessing the Involvement of Pregnant Women in Reporting Adverse Events Following Vaccination in Uganda. Victoria Prudence Nambasa
12:00
Lunch
13:30 |📍CMR Theatre Symposia
S4: RWE to identify, assess or monitor safety signals in digital era.
Gianluca Trifiro, Verona University, Italy
Darmendra Ramcharran, GSK, USA
Can AI improve RWEgeneration for safety signal management?
Stefania Spila-Alegiani/Marco Massari, National Institute of Health, Italy
Large scale distributed database networks for postmarketing surveillance of drugs and vaccines: the Italian experience
Luis Pinheiro, EMA, Netherlands
How RWE can support informed regulatory decision making? The European Medicine Agency -promoted Darwin- EU project
Niklas Noren, UMC, Sweden
Recommendations for the use of RWE to inform decision-making throughout pharmacovigilance signal management
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 International
S6: Review of policy/ legislation/ regulation that can influence ecopharmacovigilance.
Joseph Mitchell, UMC, Sweden
Dr. Ratinder Jhaj, AIIMS Bhopal, India
Ecopharmacovigilance: Introduction and overview
Joseph Mitchell, UMC, Sweden
A Description of Environment-Related Reporting for Medicines in VigiBase
Soko Setoguchi, Rugters , USA
Interplay Between Medication Use and Climate Change: How Use of Medications Impact Health Outcomes and Planetary Health in Era of Climate Change
Oral Presentation
Targeted detection of pharmaceutical residues in fish and macroinvertebrates around the wastewater treatment at Yaounde University Teaching Hospital , Cameroon, Tchadji Mayoudom Vanessa Edwige
15:00
Coffee Break
15:30 |📍CMR Theatre Symposia
S7: Collaborative Initiatives for Safer Medications: Unifying Global Pharmacovigilance in the joint mission to prevent errors
Alem Zekarias, UMC, Sweden
Global patterns and trends in medication error reporting: a descriptive analysis of VigiBase
Rita Jew, ISMP, USA
Impact of label design on medication errors
Brian Edwards & Angela Caro, ISoP
ISoP’s contributions to tackling medication errors
Comfort Ogar, ISoP Africa Chapter
Medication error experiences, reflections from the African region
Carolyn Hoffman, ISMP Canada
The Essential Voice of Patients and Families in Advancing Medication Safety
Parallel
15:30 |📍CMR Cartier
S8: Unleashing the potential of digitalization in empowering patient engagement.
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
Oral Presentations
Standardized Approach Using Focus Groups to Obtain Healthcare Professionals feedback on Design and Content of Additional Risk Minimization Measures. Fadi Alanazi
Consumer versus Healthcare Worker Spontaneous Reporting of Adverse Events Following Immunization in sub-Saharan Africa: Insights from Uganda’s National Pharmacovigilance Database. Ronald Kiguba
Parallel
15:30 |📍CMR International 1
S9: Digital tools in Pharmacovigilance and how they can be improved.
Mark Perrott, Axian, UK
Introduction to the factors driving the adoption of digital approaches in risk management
Jean-Christophe Delumeau, Institute of Pharmacovigilance, Canada
How ISoP is responding to digital risk management opportunities
Liza Rodriguez, BMS, USA
Digital Innovation Effectiveness in Risk Management: Leveraging Technology to Mitigate and Manage Risks
Robert Massouh, GSK, UK
Challenges and Opportunities in measuring the effectiveness of Risk Minimisation Measures
Priya Bahri, EMA, Netherlands
Digital support to risk minimisation – a perspective from pharmacovigilance in a changing world
Oral Presentation
A Decision-Support Platform Powered by AI and Humans-in-the-Loop Boosts Efficiency and Assures Quality in FDA’s Pharmacovigilance. Taxiarchis Botsis
Parallel
French Session
15:30 |📍CMR International 2
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 and French Network of Regional Centers of Pharmacovigilance , 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
Oral Presentations
Signal Amplification in Pharmacovigilance Using Hospital Clinical Data Warehouse: A Case Study of PCSK9 Inhibitors and Tendinopathy. Clément Cholle
Association between major cardiovascular events and esketamine: A disproportionality analysis in the WHO pharmacovigilance database. François Montastruc
17:00
End of day
17:30 Student Meet & Greet
Friday
October
04
07:00 – 8:00 |📍CMR International
Nitin Joshi, Editor-in-Chief of the ISoP's official journal Drug Safety
Meet-the-editor Session
08:30 |📍CMR Theatre Symposia
Rebecca Chandler, CEPI, Sweden
P2: Preparedness for the next disaster
Eileen Farnon, Brighton Collaboration, USA
Tools and guidance to support robust and efficient generation of evidence of safety
Bruce Carleton, University of British Columbia, Canada
Genomics of vaccine safety
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 Symposia
S10: Opioids
Rania Mouchantaf, Health Canada
Introduction
Bic Nguyen, US FDA, USA
US Perspective
Rania Mouchantaf, Health Canada
Canadian Perspective
Deusdedit Mubangizi, WHO, Uganda
WHO Perspective
Eilaine Morrato, DrPH MPH CPH - Loyola University, USA
Panel
Luis Pinheiro, EMA, Netherlands
Panel
Parallel
10:30 |📍CMR Cartier
S11: PV Training Needs and PV Professional Certification.
Jan Petracek, iVigee, Czech Republic
ISoP Global Pharmacovigilance Professional Certification – lessons learned
Nadja Jastrebova, UMC, Sweden
Current pharmacovigilance training needs among WHO PIDM members
Ghita Benabdallah, Centre National de Pharmacovigilance, Morocco
Involvement in Developing PV in LMIC through capacity building
Omar Aimer, NASoP President, Canada
Pharmacovigilance and Drug Safety training in Canada
Oral Presentation
Strengthening Signal Detection and Causality Assessment Capacity Among National Pharmacovigilance Centre Staff: A Stepwise Pedagogical Approach for UMC’s Hybrid Course. Elki Sollenbring
Parallel
10:30 |📍CMR International
S12: CIOMS Guidelines on Benefit-Risk, RWE, and Artificial Intelligence.
Niklas Noren, UMC, Sweden
Manal Younus, Iraqi PV Centre, Iraq
Introduction
Ana Claudia Ianos, Pfizer, USA
CIOMS XII: Benefit-Risk balancefor medicinal products
Taxiarchis Botsis, Johns Hopkins University USA
CIOMS XIV: Artificial Intelligence in Pharmacovigilance
12:00
Lunch
13:30 |📍CMR Theatre Symposia
General Assembly
Angela Caro, ISoP President, Colombia
Executive Committee Presentation
SIGs Update
Chapters Update
Brian Edwards, ISoP Vice-President, UK
Executive Committee Presentation
Monica Tarapués, ISoP General Secretary, Ecuador
Executive Committee Presentation
Omar Aimer, ISoP Treasurer, Canada
Executive Committee Presentation
15:00
Coffee Break
15:30 |📍CMR Theatre Symposia
S13: Registries and other cohorts utilising artificial intelligence in PV: Principles and examples.
Ushma Mehta, Cape Town University, South Africa
Western Cape Provincial Health Data Centre (PHDC) a pharmacovigilance resource in South Africa
Katarina Ilic, Celldex Therapeutics, USA
Basic overview of registries
Leyla Sahin, US FDA, USA
FDA perspectives on registries for PV including AI
Kristian Thorlund, AI, Canada
Artificial intelligence (AI) for augmenting post-market surveillance of serious drug-induced adverse events.
Oral Presentation
Multiple gestation births and perinatal outcomes in pregnancies secondary to clomiphene citrate treatment: a nationwide cohort study. Laurent Chouchana
Parallel
15:30 |📍CMR Cartier
S14: Pharmacogenomics in PV.
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 International 1
S15: Automation in PV.
Francesco Salvo, Université de Bordeaux, France
Intelligent automation and artificial Intelligence in PV: strengths and limits
Mehdi Benkebil, ANSM, France
Use Cases of Artificial Intelligence in the French Pharmacosurveillance System
Ryan Walker, Oxford University, UK
Automation in LMIC
Humaira Qurashi, Qinecsa, UK
Ushering the New Era of Pharmacovigilance
Oral Presentations
Abstract presentation: An improved method for identifying duplicates in global databases of adverse event reports for medicines and vaccines, Jim Barrett
Enhancing Local Literature Screening in Pharmacovigilance with an Automated Approach, Artem Horilyk
Parallel
Spanish session
15:30 |📍CMR International 2
Avances y retos en Farmacovigilancia en la region de Latino América (Advances and Challenges in Pharmacovigilance in the Latin American Region)
Patricia Zuluaga, Colombia
Introduction and framework
Diego Alexander Salas. Fifarma, Mexico
Regulatory harmonization in Latin America: the issues and impact in PV
Paul Alfonzo Perez, Head of Pharmacovigilance and Technovigilance for the Medifarma S.A. Company
Pharmacovigilance in traditional medicine in Latin America: State of Art
Salvador Alvarado, UMC, Sweden
Advances in the implementation of international standards in different countries of Latin America.
Angela Caro, ISoP President, Colombia
PV engagement in Latin America: some successful strategies for patient and healthcare professional engagement
Oral Presentation
Exploring the Relationship Between Medication Use and Falls Among Older Patients in Peru: A Retrospective Observational Study, Teodoro Oscanoa
Effectiveness of an automated tool for COVID-19 mRNA vaccine ESAVIs: data collection analysis and regulatory compliance in Mexico during pandemic, Betty Duarte
17:00
End of day
Conference Dinner
Saturday
October
05
08:30 |📍CMR Theatre Symposia
P3: Advancing Safety with New Technologies in Medical Devices and Combination Products
Marina Malikova, Boston University, USA
Samina Qureshi, MSSO, USA
Role of MedDRA for Medical device safety reporting
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 Symposia
P4: The Future of Pharmacovigilance. Challenges and opportunities in a fast-changing environment from different angles
Maribel Salas, Bayer, USA
Monica Munoz, US FDA, USA
US FDA perspective
Shanthi Pal, WHO, Switzerland
WHO perspective
Alex Dodoo, Ghana Standards Authority, Ghana
PV in African region perspective
Luis Pinheiro, EMA, Netherlands
EMA perspective
Peter Hjelmström, UMC, Sweden
Global standardization for safer use of medicines and vaccines
Alexander Biedermann, Bayer, Germany
Pharmaceutical industry perspective
11:10 |📍CMR Theatre Symposia
P5: Bengt Erik Wiholm Lecture
Brian Edwards, ISoP Vice President, UK
The system to optimise use of medicines and devices ultimately depends on human performance
12:00 |📍CMR Theatre Symposia
Closing Ceremony
Angela Caro, ISoP President, Colombia
Closing remarks
Omar Aimer, ISoP, Canada
Thank you notes
Maribel Salas, ISoP, USA
Thank you notes
Hadir Rostom, ISoP Egypt Chapter
Presentation of ISoP 2025
13:00
Lunch
End of the Conference
