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SELECTBIO Conferences Stem Cells & Cell Therapy Summit

Alison Wilson's Biography

Alison Wilson, Principle Consultant, CellData Services

Alison is an independent regulatory affairs consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 20 years experience of regulatory affairs in medicinal products, human tissue products and medical devices. Her consultancy provides strategic regulatory and development advice for a range of UK, EU and US clients seeking to commercialise advanced therapy medicinal products (ATMPs) in the EU. 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 RGM/1 – Regenerative Medicine.

Alison is a Module Advisor for TOPRA MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) and the TOPRA MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology). She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.

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ATMPs: A Regulatory Route-map

Friday, 6 September 2013 at 14:15

Add to Calendar ▼2013-09-06 14:15:002013-09-06 15:15:00Europe/LondonATMPs: A Regulatory Route-mapStem Cells and Cell Therapy Summit in London, UKLondon,

The field of cell therapy covers a huge range of concepts and therapeutic approaches. Many of these are at early stages in development, and are frequently associated with clinician-led academic groups and small spin-out companies rather than large pharmaceutical companies. The regulatory frameworks surrounding the clinical development, manufacture and approval for marketing of cell therapies are complex and may be outside the expertise of the early development teams in small organisations. The key to designing an appropriate development programme that will deliver all of the necessary data for clinical use and ultimately commercialisation of a cell therapy product is a clear understanding of how the product will be regulated.

This presentation will discuss the broad concepts that determine whether a cell therapy product will be regulated under the Advanced Therapy Medicinal Product (ATMP) Regulation, and then give an overview of the specificities of ATMP requirements within the EU’s medicinal products regulatory framework. Guidance will be given on the types of advice and support available for development of cell therapies within the ATMP regulation, and the key development stages at which scientific advice should be considered.

Add to Calendar ▼2013-09-05 00:00:002013-09-06 00:00:00Europe/LondonStem Cells and Cell Therapy SummitStem Cells and Cell Therapy Summit in London, UKLondon,