DIA 2026 Global Annual Meeting: Full Schedule

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11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?

Monday June 15, 2026 11:00am - 12:15pm EDT

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25

This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care.

Learning Objectives

Describe the changes in availability and use of different data sources for safety surveillance across the healthcare landscape in the future; Identify the challenges for data collection, monitoring and assessment of safety data from evolving real world use of healthcare products; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.

Chair

Alison Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Forum | 03: Data-Tech-AI, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Data Management & Data Standards
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2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

Monday June 15, 2026 2:30pm - 3:30pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00

The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.

Learning Objectives

Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports; Describe a practical framework for critically appraising of AI models and systems, with focus on risk based approaches, human oversight, validity and robustness, transparency, data privacy, fairness and equity and governance.

Chair

Phil Tregunno

Speaker

Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC

Panelist
Beth Anne MacEntee Pileggi, BSN, MBA

Panelist
Walter Straus, DrMed, MD, MPH, FACP

Speakers

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden

Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States

Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →

Walter Straus

Vice President, Safety and PV, Moderna, United States

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
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4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning

Monday June 15, 2026 4:00pm - 5:00pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00

This session shares US, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female, young and older patients) in local contexts.

Learning Objectives

Describe needs and methods for tailoring risk minimization interventions to special patient populations; Recognize challenges and opportunities of digital support to implementing risk minimization interventions with examples; Discuss experiences from around the globe with localization of risk minimization interventions and reliance.

Chair

Priya Bahri, PHD

Speaker

Panelist
Shelley Gandhi, MS

Localisation of risk minimisation interventions – Low- and middle-income countries and global reliance
Jean-Christophe Delumeau, MD, PHD

Tailoring risk minimisation interventions - Applying implementation science and user-testing
Meredith Yearsley Smith, MPA, FISPE

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda

Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic

Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Rare Disease & Special Populations
Feature Topics Patient-Centered Design and Experience
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