Course Overview

Partnerships between pharmaceutical companies to develop and market products are becoming increasingly common. Due to the stringently regulated environment for pharmacovigilance activities and responsibilities, particularly in Europe, all parties to licensing agreements need to be fully aware of, and compliant with, the pharmacovigilance requirements that are often detailed in separate safety agreements. In the EU, the expectations for Marketing Authorisation Holders (MAHs) to ensure fulfilment of pharmacovigilance obligations when entering into contractual arrangements with Third Parties are provided in EU Good Pharmacovigilance Practice guidelines.

Our Pharmacovigilance in Products Subject to Licencing Agreements course provides delegates with an overview of the nature and types of relationships and agreements between such partners. Delegates will be equipped with practical advice on how partners should remain compliant with legal requirements. In addition, the course will provide an overview of other relationships where safety language may be appropriate in other contracts/agreements and things to consider in documenting such relationships in the Pharmacovigilance System Master File.

The Pharmacovigilance in Products Subject to Licensing Agreements course is a balanced mix of presentations and workshops facilitated by speakers with experience in these areas.

*Please note that the course dates and programme may be subject to change.

This course is aimed at:

• Pharmaceutical industry personnel from areas including pharmacovigilance, drug safety, regulatory affairs, clinical research and legal departments
• Staff from regulatory authorities