CMC
Regulatory affairs
Connecting Pharmacovigilance to the Regulatory Affairs Landscape
Agenda: Responsibilities of the marketing authorization holder in connection to QPPV & PV; Quality management system of the MAH and requirements; Cross-functional collaboration within the Pharmaceutical company; PV and RA collaboration in Variations and referral…
CMC
Regulatory affairs
Tackling US & EU Biotech development
Agenda covered: Initial regulatory filing strategy for early phase clinical in the US and EU; Large molecule scale up; Rule 30, imports, foreign trade zone