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Health Authority Session

Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network

Wednesday, September 18, 2024

9:15 AM – 10:30 AM PDT

Location/Room: 104 A

Presenter(s)

Sabine Haubenreisser, MSc, PhD

Principal Scientific Administrator
European Medicines Agency, Netherlands

Slides
Andrea Laslop, MD

Head of Scientific Office
Austrian Medicines and Medical Devices Agency, Austria
Anabela Marcal

EMA Liaison Official to FDA
European Medicines Agency

Presenter (Remote)(s)

Caroline Pothet

Head of Advanced Therapies and Hematological Diseases
European Medicines Agency, Netherlands

The Europe Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an ATMP.

Learning Objectives:

Understand and describe the centralised procedure for Marketing Authorisation.
Understand and describe the various Committees and platform to support Innovation in the EU
How to successfully navigate the European system when developing an Advanced Therapeutic Medicine and bringing this to a European Marketing Authorisation.