This two-day event has been designed to provide an essential overview of veterinary pharmacovigilance and will offer practical guidance and basic training for all those working in drug safety in the EU.
Our experienced trainer will clarify roles and responsibilities, explain commonly used terminology and take participants through all the key aspects of this complex subject. There will be plenty of time for interaction and questions and answers to enable participants to get a good understanding of the issues involved. The use of industry case studies will demonstrate real-life scenarios to help embed learning.
Benefits of attending:
- Gain an overview of the European regulatory framework
- Understand the requirements of the new EU pharmacovigilance legislation
- Learn about VICH
- Understand adverse event reporting
- Hear about causality assessment
- Minimize the impact of data with errors
- Get to grips with literature searches
- Understand UK PV requirements post-Brexit
Certifications
- CPD: 12 hours for your records
- Certificate of completion
Agenda
What is pharmacovigilance?
- Beneficial and harmful effects of veterinary medicinal products
- Key definitions
The current regulatory framework and its global impact
- Overview of European regulatory framework, the EU pharmacovigilance legislation
- Implications for global environment - link to VICH
- Practical applications of definitions
- Role of the MAH
- Role of the NCA/EMA
- Role of the QPPV
Adverse event reporting
- Definitions
- Impact of VICH guidelines
- Expedited vs periodic
- How to handle animal SARs
- Handling human SARs
- Understanding the wider scope of pharmacovigilance
Causality assessment
- The principles of causality assessment with practical examples
- Medical evaluation of individual reports of adverse events
- Strategies for follow-up
Pharmacovigilance case studies
Electronic communication in pharmacovigilance
- Reporting in EV Vet
- VEDDRA
Minimising the impact of data with errors
- Consistent assessment and coding
Clinical trial AE reporting requirements
- Post-authorisation safety studies
- Phase IV studies
Literature searches
- Peer-reviewed worldwide literature
- Local journals and magazines
PSURs
- VMD (UK), VDD (Canada) and APVMA (Australia) requirements
- Format and content of the PSUR
- Analysis of data
- Incidence calculation
- Compliance and the PSUR
Practical workshop on PSURs
Speakers
Mr Declan O'Rourke,
Director ,
Ortec PV Consultancy IrelandDeclan 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.
Who Should Attend
The course will be beneficial to those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers, together with regulatory affairs and personnel from registration departments, will also find this seminar useful.
