Frank Montgomery


Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He is now Global Head Regulatory CMC for AstraZeneca.

Frank is a member of ICH Expert Working Group (EWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management working alongside ICH regulatory agency members drafting the guideline. He has been a member of the EWG since its initiation in 1994 and has been responsible for leading teams drafting several sections of the guideline.

He has presented and organised several international conferences on implementation of QbD & ICH Q12 for DIA, ISPE, PDA, CASSS, facilitated training activities for regulatory agencies including NMPA/CCFDIE and joint workshops with regulatory agencies EMA/EFPIA on learning from implementation of ICH Q8-11 and opportunities for ICH Q12.