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How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients
Session Chair(s)
Michael Berntgen, PHD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The European Medicines Agency offers medicine developers various platforms for dialogue and interaction. This session will provide an overview of such platforms and for which type of product developments they could be more suited and beneficial.
Learning Objective : Discuss EMA’s offers to support developers in early stages of their programmes; Describe value of early interaction for future successful marketing authorisation application; Identify opportunities to involve other stakeholders such as patients, health technology assessment bodies and payers; Describe the opportunities to engage with other international regulators at the same time.
Speaker(s)
Iordanis Gravanis, DrMed, PHD
Scientififc Advice, Scientific Evidence Generation, Human Medicines, European Medicines Agency, Netherlands
Overview of EMA Platforms for Interaction During Medicines Development
Marie Deneux, PHD, MSC
Chief Regulatory Officer, Lysogene S.A., France
A Product Journey by an SME: Interacting with Regulators - A Case Study
Anja Langeneckert, PHD, RPH, RAC
Head EU Regulator Affairs, Product Development, F. Hoffmann-La Roche Ltd., Switzerland
Value of Early Interaction with EMA, Also for Successful Steps Toward Access, i.e. HTA and Payers Involvement: A Case Study
Niklas Hedberg, MPHARM
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTA Perspective
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