Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. During that time Frank led projects from pre-clinical development through to lifecycle management and divestment of commercial products. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/ Medimmune. Frank has presented at a number of International conferences on implementation of QbD including DIA, ISPE, PDA and more recently a major EMA/EFPIA workshops on learning from implementation of ICH Q8-11 and opportunities for ICH Q12. 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.