Course overview
This two-day course offers a thorough examination of EU Regulation (2019/6) on Veterinary Medicinal Products, alongside Veterinary Good Pharmacovigilance Practices (VGVP). In addition, we will explore the implications of The Veterinary Medicines (Amendment etc.) Regulations 2024.
Designed for professionals seeking both clarity and applicability, the course features interactive sessions where delegates can engage directly with our experienced trainer. Participants will have the opportunity to discuss current challenges, share insights, and gain practical guidance to apply in their day-to-day work.
CPD Hours: 12
Course Content
- Day 1
- The PSMF
- PSMF Appendices
- PV training
- Product safety reviews
- Company core safety information
- Compliance and PV
- PV reporting in licensing/distribution agreements
- Day 2
- Signal detection requirements - EU & VMD
- EV Vet DWH demo
- Signal detection/benefit-risk and risk management
- Audits and inspections: are you ready?
- Risk management dealing with an alert
Speakers
Declan O'Rourke
Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.
He is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec PV Consultancy Ireland specialising in pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.
He is Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School and Past President of British Cattle Veterinary Association.
