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ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course for Singapore’s Health Sciences Authority (HSA) in November.
Stuart Finnie
Gilead Sciences
Senior Director, CMC RA
Dr Stuart (Stu) Finnie is a Regulatory Affairs professional with over 25 years of experience within the Pharmaceutical Industry and is currently with Gilead Sciences Inc. as a Senior Director in their CMC Regulatory Affairs Policy, Advocacy and Intelligence group. Working within the field of Chemistry, Manufacturing and Controls (CMC) he has developed experience of both synthetic and biological molecules from development through to life-cycle management. He is a member of EFPIA’s Manufacturing & Quality Expert Group and the Environment and Chemicals Expert Group. He has been part of a number of advocacy initiatives, including EFPIA’s initiative around accelerated product development, various initiatives around ICH Q12 and the EFPIA teams supporting various ICH initiatives including ICH M4Q(R2) and ICH M16, both of which aim to transform the way in which we interact with agencies in the CMC area. He is also an active member of ISPE and leads the ISPE PQLI ICH Q12 and the “Science and Risk-based Specifications” teams.
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ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.
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Cell and gene therapy (C>) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...