Volume IXb is the new key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company. It will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products and its impact on pharmacovigilance.
PROGRAMME TO INCLUDE
- Overview of European regulatory framework
- PV Training
- Product Safety Review
- Company Core Safety Information
- Compliance and PV
- PV Reporting in Licensing/Distribution Agreements
- Signal Detection
- Benefit-Risk Assessments
- Risk Management
- Crisis Management
- Implications of the proposed EU Pharmacovigilance legislation
This course will be beneficial to those who have some experience of Veterinary Pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance course run by Management Forum. Adverse event monitoring and drug safety offices together with regulatory affairs and personnel from registration departments will find this seminar useful.
For more information about this conference visit https://www.researchandmarkets.com/research/jxf553/two_day_advanced?w=4