Dr. Carolyn Gordon, AstraZeneca - Qepler Summits And Conferences

Dr. Carolyn Gordon

Director, Regulatory CMC, Global Regulatory Affairs
United Kingdom
AstraZeneca - Research-Based BioPharmaceutical Company

Carolyn brings wide ranging experience across Global Regulatory Affairs and Pharmaceutical Development, covering multiple Therapy Areas (Infection, Oncology, CV, Diabetes). Carolyn graduated from Edinburgh University with a PhD in peptide chemistry. She started her career with AstraZeneca in the Pharmaceutical Development department, working on early product development. After joining Regulatory CMC, Carolyn was involved with the creation of one of the first AZ marketing applications authored using ‘Quality by Design’ (QbD) principles.

Carolyn’s current focus is on the CMC content of global marketing applications, including strategies to manage post approval change for a complex, multi-market, drug-device combination product. As a result of this, she has led technical discussions with international Regulatory agencies such as ANVISA (Brazil) and CDE (China). Her current interests cover small and medium sized molecules, polymers, sterile processing and combination products.

Related Sessions:

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
CASE STUDY: Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment

CMC dossier content strategy and device Post-approval change management

  • Device specific content strategy for DDC’s
  • Annex I MDR vs MDD – additional requirements
  • A view on post approval change management
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