Date: Thursday 26 September 2019
Time: 12:00 - 13:00 BST (GMT+1)
- EU and USA requirements form CMC dossiers for ATMPs/ gene and cell therapy products.
- Challenges for specific advanced therapy product types.
Regulatory Professionals professionals with little or no prior knowledge of the CMC requirements for ATMPs.
Alison Wilson, Cell Data Services
Alison is an independent regulatory affairs consultant. She has over 25 years’ experience of regulatory affairs in medicinal products, cell-based therapies and medical devices, and advises a range of EU and US clients on regulatory strategy and development of ATMPs. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 - Tissue Engineered Medical Products and a member of BSI Technical Panel BTI/001 – Biotechnologies.
Alison is a Fellow of TOPRA, and has an MSc in stem cell biology and regenerative medicine.
Alexis Cockroft, Lex Regulatory Ltd
Alexis is currently an independent regulatory consultant for Lex Regulatory Ltd, specialising in CMC regulatory science for gene and cell therapy products. She has worked in CMC regulatory roles for more than 13 years and has focused exclusively on gene/cell therapy projects for the last eight years, which included five years as the CMC RA lead for the Strimvelis MAA. Her experience extends from early phase to post-authorisation and for various global markets including USA and Europe.
Alexis has a PhD in molecular biology and more than 25 years of knowledge from science-based roles.
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
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