戻る Agenda
Session 3: The New Pharmacovigilance Regulations
Session Chair(s)
Diptee A. Gajjar, PhD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
- Pharmacovigilance assessment procedures and interactions with committees
- Pharmacovigilance System Master File
- Risk management plan
- Periodic Safety Update Report (PSUR)
- Changes to Summary of Product Characteristics (SmPC) and Package Leaflet (PL)
- Transparency and information