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CHALLENGES IN IMPLEMENTING THE UPDATED RMP GUIDANCE – STAKEHOLDERS’ PERSPECTIVE
Session Chair(s)
Jordi Llinares Garcia, MS
Head of Research and Innovation
European Medicines Agency, Netherlands
Zeljana Margan Koletic
HALMED, Croatia (Hrvatska)
PRAC and Industry’s perspectives on the implementation of the updated guidance will be complemented by additional EMA guidance and advice on procedural aspects of RMP submission.
Speaker(s)
PRAC perspective on RMP guidance
Sabine Straus, MD, PhD, MSc
Medicines Evaluation Board (MEB), Netherlands
PRAC Chair, Staff Member
Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders
Emil Andrei Cochino, MD, MHS
European Medicines Agency, Netherlands
Scientific Senior Specialist (Risk Management)
Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders
Nuria Semis-Costa, MSc
European Medicines Agency, Netherlands
Scientific Specialist (Risk Management)
RMP guidance implementation – Industry perspective
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
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