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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Alastair Nixon
Senior Director, Data Strategy at GlaxoSmithKline Research & Development Limited, UK
Speaker

Profile

Alastair has worked in various roles in pharmaceutical product development, before moving into regulatory publishing at a major clinical research organisation. He then headed the International Regulatory Operations function at SmithKline Beecham and GSK, and as Director of Publishing, he led the UK based publishing team, working on the implementation of eCTD in the company. Alastair is now Director, Submission Standards at GSK, responsible for ensuring that GSK’s strategy with respect to electronic submissions and IDMP is aligned with external requirements. He is a member of the EFPIA IDMP Sub Group of ERAO and active on several European projects, such as eAF and Digital Application Dataset Integration (DADI). Alastair has a BSc (Hons) in Applied Chemistry from the University of Aston in Birmingham.

Agenda Sessions

  • Electronic Application Forms (eAF): Where Are We Now?

    15:15
  • Electronic Application Forms (eAF): Where does Web eAF fit in with intended Target Operating Model?

    09:55