
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.
Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.
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.
Published: August 16th 2022 | Updated: