Course Overview

EU pharmacovigilance regulations and guidance (Good Pharmacovigilance Practice, GVP) govern the requirements of pharmacovigilance of medicinal products in the European Union. They describe the structures, obligations, procedures, roles and activities of the various stakeholders. These are detailed for the collection, verification, presentation and interpretation of adverse reports to exchange information within the EU, to monitor safety products on the market in the EU, to proactively manage safety concerns and to guarantee continuous surveillance of the benefit risk profile of such drugs.

The EU and UK Regulations and Guidelines for Pharmacovigilance course will cover the development and current requirements of Good Pharmacovigilance Practices. The course will also cover other aspects of the current legislation including new requirements for pharmacovigilance in UK following the end of the Brexit transition period. The course will provide delegates with a professional working knowledge of EU and UK Pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance.

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

Our courses are recognised by PharmaTrain. 

This course is aimed at:

• Pharmaceutical industry personnel from areas including drug safety, clinical research, medical affairs, medical writing, regulatory, and medical information
• Staff from regulatory authorities