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Wednesday, June 19 • 3:15pm - 4:15pm
#367: EMA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-667-L04-P; CME 1.00; RN 1.00

The European Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an Advanced Therapy Medicinal Product (ATMP).

Learning Objectives

Describe the assessment procedure and the role of CHMP and rappoteur; Describe platforms to support developers; Discuss a successful submission of an ATMP.

Chair

Steffen Thirstrup, MD, PhD

Speaker

Panelist
Sabine Haubenreisser, PhD, MSc

Panelist
Anabela Marcal, PharmD

Panelist
Evdokia Korakianiti, PhD, MSc


Speakers
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum