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Session 1: A Year in Review
Session Chair(s)
Simon Dagenais, PHD, MSC
Asset lead, Medical evidence development, Pfizer Inc, United States
This opening session will provide attendees with an overview of key events related to RWE in the past year (2022-2023). This session will set the stage and introduce various topics that will be discussed in greater detail in other sessions later in the agenda.
To help attendees understand why the key events presented are important to the field of RWE, they will be placed in a historical context to describe how they build on previous events and contribute to the evolution of RWE. This session will focus primarily on the following groups of stakeholders:
- Biopharmaceutical companies who acquire and analyze RWD to develop RWE
- Regulatory agencies who review RWE and make regulatory decisions based on RWE
- Academic researchers who propose analytical methods and standards for the analyses of RWD
- Private industry vendors who develop, aggregate, disseminate, and analyze RWD
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify key events related to RWE in the past 1 year period
- Cite these events in a historical context to describe how they build on previous key events in RWE
- Examine how these events are interrelated and contribute to the evolution of RWE
Speaker(s)
Stefanie Prilla, DRSC
RWE Coordinator, European Medicines Agency, Netherlands
EMA Update
Rob Kalesnik-Orszulak, PHARMD
Head of Regulatory Affairs, Retro Biosciences, United States
A Short Trip Around the World: A Simple Understanding of the Complex Web of Regional Regulatory Guidances
Shahid Hanif, PHD, MSC
Managing Director, GetReal Institute, Netherlands
GetReal Institute: Developing a Multistakeholder Approach to Advance the use of RWE for Better Healthcare Decision-making
Simon Dagenais, PHD, MSC
Asset lead, Medical evidence development, Pfizer Inc, United States
Speaker
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