EMA and EATRIS present: Navigating the Regulatory Requirements for ATMPs

Date & Time 29 November 2021 at 13.00-14.00 CET
Location Webinar

In this webinar we will discuss a non-linear development programme and share developmental scientific and regulatory issues commonly encountered in ATMP dossiers.

Developers of ATMPs face challenges due to the complexity of these products and may encounter challenges in navigating – and complying with – regulatory requirements. The development programme can differ substantially from that of chemical and simpler biologicals, and existing guidelines may not apply or have additional requirements.

Host: David Morrow, EATRIS

David Morrow is Programme Manager Translational Medicine & Drug Development at EATRIS. David received a BSc (Hons) in Molecular Biology from University College Dublin in 2001 and a PhD in Vascular Biology from Dublin City University in 2006. This was followed by an American Heart Association Postdoctoral Fellowship at the University of Rochester Medical Center, NY from 2006-08 which resulted in an American Heart Association Young Investigator Award in 2008. From 2009-2015 he was an NIH/American Heart funded Principal investigator heading multiple projects in Cardiovascular disease and Cancer. David also holds an MBA in health science management and has worked as a consultant and in technology transfer in life sciences.

Speaker: Charlotte Bakker, EMA

Charlotte Bakker works as seconded national expert in the Translational Sciences Office of the European Medicines Agency (EMA). As medical doctor, she gained experience in pediatrics and in the intensive care unit. In 2015-2020 she worked as research physician and project leader conducting mainly early phase clinical trials investigating symptomatic treatments of neurodegenerative diseases. Additionally she investigated methodologies that can be applied to early phase clinical trials. During this period she learned the importance of non-linear drug development. In addition to her work as a scientist, she has obtained qualifications in clinical pharmacology.

 

The webinar is hosted by the ADVANCE Programme and EATRIS  in collaboration with the European Medicines Agency.

Registration is open here.