戻る Agendas
BENEFIT/RISK- PRAGMATIC LIFECYCLE MANAGEMENT
Session Chair(s)
June Raine, MD, MSC, FRCP
Chief Executive
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety
Eli Lilly and Company Ltd, United Kingdom
The benefit/risk profile of a medicinal product must be favorable to gain and maintain marketing authorisation. From a pragmatic view, however, different approaches and proportionality are needed to assess and manage the benefit-risk balance across a product’s lifecycle in a resource-appropriate manner. This session will address practical aspects of benefit-risk management from First-In-Human studies through late-cycle product maturation. Different lines of evidence, challenges in their evaluation, and triggers for PASS and PAES will be discussed in a pragmatic context, considering both patient safety and the changing realities of data across a product’s lifecycle.
Speaker(s)
How is the Regulatory Framework Helping?
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Will the New PROTECT Tools Make a Difference?
Shahrul Mt-Isa, PHD
MSD, United Kingdom
Associate Principal Scientist, HTA Statistics, BARDS Europe
Assessment of Benefit/Risk in the Lifecycle of Biologics
Isma Linda Benattia, MD
Amgen Inc., United States
Vice President Global Patient Safety
Panel Discussion
Tomas Salmonson, DrMed, PHD
Critical Path Institute, Netherlands