Type of webinar

Language

Quality compliance

Driving Quality compliance improvement

Agenda covers Key definitions, triggers and risks, Solution for sustainable quality improvement, and Maturity Level Assessment
CMC

CMC Healthchek: Project Management and CMC Strategies for Successful Product Development

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
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