Fionnuala O’Driscoll has a degree in Biochemistry and a Master’s Degree in Clinical Pharmacology and in Industrial Pharmacy. She has worked in Regulatory Affairs for over 25 years and is currently Director of Global Regulatory Affairs – CMC at Eli Lilly with responsibility for the global drug substance platform across Lilly’s large molecule and small molecule portfolio. Throughout her career she has worked on many different global regulatory projects in numerous companies including Johnson and Johnson (Janssen Biologics), Fournier Laboratories, Organon Laboratories, CeNeS and Newport Pharmaceuticals. She is an active member of the EFPIA MQEG Biomanufacturing working group and chairs the EFPIA satellite session at the CASSS EU Strategy Forum every year.