The Signal and Risk Management in Pharmacovigilance MasterClass covers topics such as:
- Effective risk communication
- Global guidelines on risk management
- Signal detection in EVDAS
- RMP for Biosimilars and biologicals
- From Signal to Label (interface with Regulatory Affairs)
The Signal and Risk Management in Pharmacovigilance MasterClass brings together:
- Qualified Persons responsible for Pharmacovigilance (QPPVs)
- Risk communication experts
- Risk management planning
- Individuals involved in pharmacovigilance, safety database, signal management, and information management
- Post-authorization safety studies
- Risk minimization development
- MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
- MAAs / MAHs for generic products
