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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.
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.