Welcome | Regulations in Practice
In a change to the format of previous years, the aim of this interactive training session is to examine current and best practices in the areas of Medical Information and Pharmacovigilance. It is an opportunity to hear expert presenters and discuss current topics with other members of the industry. This training module is aimed at colleagues with knowledge of current EU guidelines who are expected to contribute to the meeting with their own experience.
Delegates may choose to attend just one or both days, and a 10% discount will be given to those booking for both days.
Topics covered:
Day 1 - Medical Information day
- Copyright & Data Protection in Medical Information
- ABPI Code in 2011
- Overview of the Blue Guide
- Impact of PV Inspections on the Medical Information Dept
- EMA Guidelines on giving Information to Patients
Day 2 - Pharmacovigilance Day
- Speaker from the MHRA, presenting on upcoming/recent changes in PV Legislation & MHRA's expectations from industry when they come into force, and recent guidelines (e.g. Green Guide).
- Speaker from the IMB presenting on inspections from a regulator's perspective and their expectations.
- Speaker from industry, presenting on outsourcing of Pharmacovigilance services - criteria to look for, potential pitfalls and ongoing management.
- Speaker from Industry presenting on PSURs
- Speaker from industry presenting on methods of monitoring quality on your safety database, source data verification and follow-ups.
To find out what previous delegates thought about this course, read the meeting report written for PIPELINE: PIPELINE Meetings Report - Regulations, Nov 2009.