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DIA 2021 Global Annual Meeting


How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients

Session Chair(s)

Michael  Berntgen, PhD

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

Overview of EMA Platforms for Interaction During Medicines Development

Iordanis Gravanis, DrMed, PhD

  • Scientififc Advice, Scientific Evidence Generation, Human Medicines
  • European Medicines Agency, Netherlands
Marie  Deneux, PhD, MSc

A Product Journey by an SME: Interacting with Regulators - A Case Study

Marie Deneux, PhD, MSc

  • Chief Regulatory Officer
  • Lysogene S.A., France
Anja  Langeneckert, PhD, RPh, RAC

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

  • Head EU Regulator Affairs, Product Development
  • F. Hoffmann-La Roche Ltd., Switzerland
Niklas  Hedberg, MPharm

HTA Perspective

Niklas Hedberg, MPharm

  • Chair EUnetHTA Executive Board; Chief Pharmacist
  • Dental and Pharmaceutical Benefits Agency, TLV, Sweden