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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)
How the PLEG Landscape Has Changed in the Past Decade – EUnetHTA perspective
Irena Guzina, PharmD, MPH, MSc
HAS, France
Medical Assessor, Coordinator of EUnetHTA WP5B PLEG Activities
Current Challenges and Gaps in PLEG and Their Implications for Regulatory and Reimbursement Decision Making
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Utilising Different Data Sources for Post-Licensing Evidence – Opportunities and Challenges
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
PLEG: The Perspective of Pharmaceutical Developers
Catherine Cohet, PhD
European Medicines Agency, Netherlands
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force
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