Welcome | Regulations in Practice
A 2 day course appropriate for all Medical Information and Pharmacovigilance professionals.
Areas covered will include:-
- Understanding regulations that apply to the Pharmaceutical Industry
- Basic Device Regulations
- New ABPI Code of Practice - one year on
- Safety surveillance - role of PSURs, Signal Detection, Risk Management
- Copyright overview
- Pharmacovigilance legislation / electronic AE reporting
- PV Inspections - the involvement of Medical Information & PV departments
- Validation of databases
- Data protection and freedom of information
To find out what previous delegates of the Regulations in Practice course thought about it, read the meetings report written for PIPELINE: PIPELINE Meeting Report - Regulations in Practice 2007.
