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Friday, June 18 • 12:00pm - 1:00pm
#524 OD: How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients

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Component Type: Session
Level: Basic

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 Objectives

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.


Michael Berntgen, PhD


Overview of EMA Platforms for Interaction During Medicines Development
Iordanis Gravanis, DrMed, PhD

A Product Journey by an SME: Interacting with Regulators - A Case Study
Marie Deneux, PhD, MSc

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

HTA Perspective
Niklas Hedberg, MPharm

avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →
avatar for Iordanis Gravanis

Iordanis Gravanis

Scientififc Advice, Scientific Evidence Generation, Human Medicines, European Medicines Agency, Netherlands
Iordanis Gravanis is a medical doctor by training and has a PhD in molecular and cellular pharmacology. He has been at the European Medicines Agency for almost 13 years, having worked initially as scientific officer in the oncology office for 5.5 years managing managing new authorisations... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board; Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and... Read More →
avatar for Anja Langeneckert

Anja Langeneckert

Head EU Regulator Affairs, Product Development, F. Hoffmann-La Roche Ltd., Switzerland
Anja is currently Head of EU Regulatory Affairs at F. Hoffmann-La Roche and her group acts as a strategic and procedural advisory body on EU questions. In her 20 years with Roche she spent most of her time in Regulatory between Headquarter and affiliate role (e.g 5 years as the DRA... Read More →
avatar for Marie Deneux

Marie Deneux

Chief Regulatory Officer, Lysogene S.A., France
Marie Deneux is in charge of defining and executing the regulatory strategy for the development and registration of Lysogene’s gene therapy products. Prior to joining Lysogene, Marie Deneux spent 15 years in consulting, where she assisted life sciences companies throughout the development... Read More →

Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session