The objective of this short course is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:
Who should attend?
This short course is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.
At the conclusion of this course, participants should be able to:
- Describe recent developments on EU Good Pharmacovigilance Practices guidance
- Examine principles for new literature monitoring and the revised EudraVigilance Access Policy
- Discuss FAQs in signal management
- Identify important aspects in preparing risk management plans and conducting - is something missing here?
- Describe key principles for pharmacovigilance audits and inspections