Jody Gould | Senior Regulatory Affairs Director
GlaxoSmithKline

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

Jody Gould, Senior Regulatory Affairs Director, GlaxoSmithKline

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Jody Gould / Can we achieve global harmonization of regulatory requirements for vaccines

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. ...

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Richard Pelt, Director, Vaccines Cmc Regulatory Affairs, Pfizer

Charles Kline, Distinguished Scientist, Merck

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Charles Kline / Can we achieve global harmonization of regulatory requirements for vaccines

Charles Kline, Distinguished Scientist,
Merck

A passionate believer in the value vaccines bring to society, Charles has served in the vaccines industry for 25 years, including 14 years in Regulatory Affairs CMC.  His career has afforded the opportunity to support a wide range of vaccine products from both a technical and regulatory...

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