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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)
Overview of EMA Platforms for Interaction During Medicines Development
Iordanis Gravanis, DrMed, PhD
European Medicines Agency, Netherlands
Scientififc Advice, Scientific Evidence Generation, Human Medicines
A Product Journey by an SME: Interacting with Regulators - A Case Study
Marie Deneux, PhD, MSc
Lysogene S.A., France
Chief Regulatory Officer
Value of Early Interaction with EMA, Also for Successful Steps Toward Access, i.e. HTA and Payers Involvement: A Case Study
Anja Langeneckert, PhD, RPh, RAC
F. Hoffmann-La Roche Ltd., Switzerland
Head EU Regulator Affairs, Product Development
HTA Perspective
Niklas Hedberg, MPharm
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTACG Co-Chair & Chief Pharmacist
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