Séverine Allard

Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.


Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions

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.