Product Develoment
Pharmacovigilance
Evolution of Pharmacovigilance in the United Kingdom post Brexit
Medtech
How to deliver A.I thanks to the development of a medical device software?
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