InTouch
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, PhD
Gilead Sciences
Senior Director, CMC RA
Stuart Finnie, PhD, is Senior Director of CMC Regulatory Affairs for Gilead Sciences. He has many years of experience in regulatory affairs, also having held positions with AstraZeneca, Amgen, and in the consulting arena. He currently serves as the Chair of the ISPE PQLI Patient Centric Specifications Team and Co-Chair of the ISPE PQLI ICH Q12 Implementation Team. He joined ISPE in 2021.
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iSpeak Blog
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...