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21st Century Pharmacovigilance: Improving Outcome Traceability for Products Across the Complexity Continuum, From Generics to Biologics and Vaccines
Session Chair(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States
In this forum, we will focus on the rationale for and implications of revisions to current postapproval generic manufacturer accountability expectations in the United States. Also, to better understand potential gaps that may exist in the adverse event reporting process for all medications, we will hear the results of two surveys, one assessing the experience for consumers and another detailing the experience for health professionals in various settings.
Learning Objective : Discuss ways to fill the key gaps across all major methods and systems used for pharmacovigilance; Describe the rationale, advantages and disadvantages of changing regulatory responsibilities for generic drug sponsors; Discuss the consumer perspective on reporting adverse events for medicines and vaccines; Identify the gaps that exist when analyzing adverse event reporting practices and processes by heath care professional and treatment setting.
Speaker(s)
Improving Adverse Event Reporting: Insights on Reporters, Treatment Settings, and Health Information Systems
Stella Stergiopoulos, MPH, MS
EQRx, United States
Director, Health Economic and Outcomes Research
Challenges and Opportunities for Generics Postmarketing Surveillance
Leonardo Ebeling, DrMed, PhD
Dr. Ebeling & Assoc. GmbH, Germany
Managing Director
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