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Session 4: Post Licensing Evidence Generation – What Is It and What Is Its Purpose?
Session Chair(s)
Niklas Hedberg, MPHARM
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Post Licensing Evidence Generation – What Is It and What Is Its Purpose?
Speaker(s)
Irena Guzina, PHARMD, MPH, MSC
Medical Assessor, Coordinator of EUnetHTA WP5B PLEG Activities, HAS, France
How the PLEG Landscape Has Changed in the Past Decade – EUnetHTA perspective
Peter Mol, PHARMD, PHD
CHMP member, NL, MEB, Netherlands
Current Challenges and Gaps in PLEG and Their Implications for Regulatory and Reimbursement Decision Making
Michael Berntgen, PHD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
Utilising Different Data Sources for Post-Licensing Evidence – Opportunities and Challenges
Catherine Cohet, PHD
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
PLEG: The Perspective of Pharmaceutical Developers
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