DIA EUROPE 2021

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ATMP Regulation 2.0 – Is the System Fit as is?

Session Chair(s)

Ana Hidalgo-Simon, DrMed

Head of Advanced Therapies

European Medicines Agency, Netherlands

In this session we will look at the specificities of ATMPs and the needs of their developers. We will explore the current regulatory framework flexibility to be fit for purpose – its ups and downs.

Learning Objective : - Understand how current regulation is applied to ATMPs in the EU - Identify main regulatory challenges and how they can be addressed when developing ATMPs - Present practical examples of good and bad fits aspects of the current regulation for ATMPs development, from different stakeholders’ points of view - Design successful plans for multipurpose (including regulatory) evidence generation

Speaker(s)

Challenges and Opportunities Regarding Regulatory/ Environmental Framework with GMO Containing IMPs - an Industry Perspective

Myra Widjojoatmodjo, PhD

Janssen Vaccines & Prevention B.V., Netherlands

Director

The RSS and the future of ATMP development in Europe – regulator perspective

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

Early Development of ATMPs by Academic Institutions – Academic Perspective

Pauline Meij

Department of Clinical Pharmacy and Toxicology, Leiden Univ, Netherlands

Head of Production ATMP / Qualified Person

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