The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge 2016 is a course that covers topics such as:
- Data/information available on the B/R ratio of a drug
- The concept of benefit/risk (B/R) ratio, also in the light of the existing EU regulations
- "gap analysis" of the existing documentation
- Different "Regulatory" and "Pharmacovigilance" documents pertaining to the different phases of the life cycle of a drug
- Different phases of the preparation of a PSUR/RMP
The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge 2016 brings together:
- Medical Departments
- Medical Affairs
- Pharmacovigilance
- Regulatory Affairs
- Medical Writing
