戻る Agendas
LIFECYCLE OF REGULATORY/HTA ADVICE
Session Chair(s)
Spiros Vamvakas, MD
Scientific Advior on Human Medicines
European Medicines Agency, Netherlands
This session will focus on the experience of the new approaches of interaction among regulators, HTAs and companies during drug development throughout the life-cycle of medicinal products. Furthermore, the session will address new concepts currently under exploration of approaching the lifecycle of medicinal products such as adaptive licensing and post-authorisation efficacy studies.
Speaker(s)
State of the EMA Adaptive Pathways Pilot Project
Hans Ovelgoenne
Medicines Evaluation Board, Netherlands
EMA-HTA Scientific Advice
Judith Creba, PHD
Novartis Pharma AG, Switzerland
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
HTA Perspective on Early Engagement in New models of Scientific Advice
Leeza Osipenko, PHD, MSC
National Institute for Health and Care Excellence (NICE), United Kingdom
Head of Scientific Advice