Diane Wilkinson, PhD AstraZeneca

Diane Wilkinson was awarded her degree in Pharmacy from University of Nottingham, UK and her PhD in Pharmaceutical biotechnology at Manchester University, UK. Diane has a 30 year career in the Pharmaceutical Industry in formulation development and Regulatory CMC and Policy, and is currently Senior Director, Global Regulatory CMC at AstraZeneca. A strong advocate for regulatory harmonization, as well as the use of science, risk based CMC approaches and acceptance of these, to help bring accelerated access to medicines for global patients, Diane is a member of EFPIA biomanufacturing team and IDQG, was co-author of EFPIA White paper on Accelerated CMC 2017, involved in 2018 workshop with EMA/FDA on CMC acceleration strategies and continues to help drive this thinking forward. Diane is also a member of Vaccines Europe COVID CMC Team and is VE representative for CEPI COVID Manufacturing SWAT, collaborating with Gavi, WHO, Bill Gates Foundation, IFPMA and the CEPI Reg. Advisory Group, with the goal of driving thinking towards same product, same science, same assessment. When not working Diane can be found with her family on their farm in the hills, watching over her sheep and rose garden and roaming in the hills and rivers.