Executive Director Global CMC Regulatory Affairs
Diane Wilkinson was awarded her degree in Pharmacy from University of Nottingham, UK and her PhD in Pharmaceutical Biotechnology at Manchester University, UK. Following a 35 year career in the Pharmaceutical Industry in formulation development and Regulatory CMC and Policy, Diane is currently Executive Director, CMC Global Regulatory Affairs at AstraZeneca, enjoying their exciting science and development of life saving medicines. Diane is a strong advocate for regulatory convergence and harmonisation, 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 the 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, to get life-saving products to patients as soon as we safely can. Diane also participated in the first ICMRA CMC meeting in July 2021.