Type of webinar


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
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…