Jody Gould | Senior Regulatory Affairs Director
GlaxoSmithKline

Jody Gould, Senior Regulatory Affairs Director, GlaxoSmithKline

Jody has worked in various Regulatory Affairs roles for more than 25 years, supporting pharmaceutical product development, approval, and life-cycle management.  Her experience includes small molecules, biologics, and vaccines; she was involved in the initial licensures of Remicade and Shingrix.  Jody is currently leads US Regulatory Policy and Intelligence for GSK Vaccines.

Appearances:



Day 2, April 8 @ 12:10

Can we achieve global harmonization of regulatory requirements for vaccines

  • Managing regulatory requirements and timelines while rolling out vaccine globally
  • Variability of assays and tests required internationally
  • Practicalities are very challenging – how do big pharma manage this?
  • Insurance of process control – what will satisfy regulatory bodies downstream?
  • When and how should you engage with regulatory bodies
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT
last published: 21/Feb/20 16:35 GMT

back to speakers