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 perspective, including bacterial, inactivated virus, recombinant protein, polysaccharide conjugate, mRNA, and combination products. Charles currently leads a team of talented CMC scientists focused on commercial supply of bacterial and recombinant vaccines, as well as supporting vaccine programs in development using novel adjuvants.
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: 05/Mar/20 10:35 GMT
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