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Virtual

May 26, 2021 6:45 PM - May 28, 2021 12:15 AM

(Central Europe Standard Time)

3rd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU

Supporting you in navigating the complex regulatory and access landscape.

Back to Agenda

Session 2: Early Interaction with Regulators, Scientific Advice and PRIME Scheme

Session Chair(s)

Maren von Fritschen, PharmD

Maren von Fritschen, PharmD

Head EU Regulatory Policy

Moderna, Netherlands

Topics explored in this Session:

  • How to meet patients’ expectations for early access to ATMPs
  • PRIME scheme: achievements and future improvements
  • How to foster global expedited pathways for ATMPs - industry perspective

Speaker(s)

Jordi Llinares Garcia, MS

PRIME achievements and future improvements

Jordi Llinares Garcia, MS

European Medicines Agency, Netherlands

Head of Research and Innovation

Jacquelyn Awigena-Cook, MSc

How to foster global expedited pathways for ATMPs - industry perspective

Jacquelyn Awigena-Cook, MSc

Bristol Myers Squibb, United Kingdom

Director, Global Regulatory Policy & Intelligence

Sam Ringle, PhD

Experiences from Early Interactions with Regulators

Sam Ringle, PhD

CSL Behring Innovation Gmbh, Germany

EU Regulatory Affairs Manager

Bettina Ziegele, MA

Simultaneous National Scientific Advice (SNSA) Pilot – first experiences and the way forward

Bettina Ziegele, MA

Division Major Policy Issues, Paul-Ehrlich-Institut, Germany

Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer,

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