This Focus Group was formed to bridge the gap between the science and regulation of medicines,
and to facilitate discussion and consideration of regulatory aspects relevant to the development of
new and improved medicines. There is considerable overlap between the specialist scientific areas
covered by APS Focus Groups and the key operations for which the MHRA has regulatory
The Regulatory Focus Group was formed in 2014 and consists of a steering committee which
currently has representation from industrial scientists at Pfizer, GSK, AstraZeneca and Bristol-Myers
Squibb, academics from the University of Bath, a regulatory consultant in product development and
regulators from MHRA.
Colm Reddington, MPharm, MSc, is Director CMC Regulatory Affairs at AstraZeneca, Cambridge, UK. He joined the CMC Regulatory Team in AstraZeneca in 2020, supporting the development and roll out of biological medicines to patients worldwide. He is currently leading global filings and post approval changes for antibody drug conjugate products from a CMC Regulatory perspective. He has previously worked for over 10 years at the UK Medicines and Healthcare Products Regulatory Agency (NHRA) as a senior pharmaceutical assessor and most recently, Assessment Unit Manager for Cardiovascular and Diabetic products..
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