Introduction to Veterinary Pharmacovigilance in the EU Training Course (ONLINE EVENT: June 26-27, 2024 and On-Demand)
Dublin, June 18, 2024 (GLOBE NEWSWIRE) -- The "Introduction to Veterinary Pharmacovigilance Training Course" conference has been added to ResearchAndMarkets.com's offering.
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
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.
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:
Declan O'Rourke
Director
Ortec PV Consultancy Ireland
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.
For more information about this conference visit https://www.researchandmarkets.com/r/cjgx6d
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