Advanced Veterinary Pharmacovigilance
The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXB, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company. The programme will also consider the potential impact of Brexit on pharmacovigilance and the implications of the proposed EU Regulation (2019/6) on Veterinary Medicinal Products.
Interactive sessions throughout the two days will give delegates the opportunity to discuss key issues of current concern with our experienced trainer.
Programme to include:
- Overview of European regulatory framework
- The key requirements of Volume IXB
- The detailed description of the pharmacovigilance system (DDPS) and the pharmacovigilance system master file (PSMF)
- PV training
- Product safety reviews
- 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
Upcoming start dates
Request information - obligation free
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Reviews by course attendees
Average rating 4.6
Declan is an excellent speaker and gave a good presentation.
Great content and discussion. Very good presentation style... Very worthwhile presentation
Extremely satisfied to have participated in this training. The information shared will be very useful for improving the management of the PV system. The speaker's experience is ...