戻る Agenda
Novel Approaches to Pharmacovigilance Collaboration
Session Chair(s)
Jose Vega, MD
Chief Safety Officer
Moderna, United States
Following the success of its clinical initiatives, TransCelerate launched its first pharmacovigilance projects in 2017, which are now actively engaging with health authorities and delivering both near-term and long-term value. This session will feature a panel of leaders from TransCelerate’s pharmacovigilance teams, as they discuss the future of pharmacovigilance (challenges associated with globalization, data automation, new PV requirements, etc.) and discuss initiatives that TransCelerate has undertaken to address these challenges.
Learning Objective : Describe expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges.
Speaker(s)
Industry Collaboration to Improve Patient Safety: TransCelerate’s Long-Term Vision to Address Pharmacovigilance Challenges
Jose Vega, MD
Moderna, United States
Chief Safety Officer
Evaluating the Value of Safety Information Data Sources: Gathering Evidence to Illustrate a Hierarchy of Value
Peter Verdru, MD
UCB Biopharma S.P.R.L., Belgium
Vice President, Head of Patient Safety
Interpretation of PV Regulations
Ajay B. Singh
GlaxoSmithKline, United States
Team Leader, Safety Evaluation and Risk Management
Value of Safety Information Data Sources
Jeremy Jokinen, PHD, MS
Argenx, United States
Vice President and Head Global Patient Safety
FDA Perspective
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER