Session objectives:
- Share high-level overview of Facilitated Product Introduction & TGA’s Regulatory Strengthening Program
- Provide platform for greater understanding of ACCESS Consortium (how it works, future plans, industry experience, etc.)
Dr Leonard Both recently joined Swissmedic`s ATMP unit. He previously worked for 10 years at another ACCESS Consortium agency, namely the UK’s MHRA, where he used to be Team Leader, Senior Quality Assessor for Biologicals, Principal Assessor to MHRA’s Vaccines Expert Working Group (EWG), and MHRA’s Licensing lead for the ACCESS Consortium.
Leonard has been a board member of the Control Programme Board (CPB) at the National Institute of Biological Standards and Controls (NIBSC) and has served on WHO, EDQM and EMA expert groups.
Leonard has scientific degrees from universities in Germany and two legal degrees from the UK, including a Master’s Degree in Law (LLM with Merit). He has a strong interest in international collaboration and regulatory convergence.
Session objectives:
