OR WAIT null SECS
Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.
September 02, 2022
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
August 15, 2022
A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.