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Management Forum

Introduction to Veterinary Pharmacovigilance Training Course

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

26-27 June 2024
+ 2-3 October 2024 »
from £1099

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course Overview

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
Minimise the impact of data with errors
Get to grips with literature searches
Understand UK PV requirements post Brexit

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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.

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This course will cover:

Day 1
Day 2

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

Identifiable Reporter

Do vets report AEs and why?

Electronic communication in pharmacovigilance

Reporting in EV Vet
VEDDRA

EV Vet demo

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

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Declan O'Rourke
ORTEC PV Consultancy Ireland Ltd

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

26-27 June 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13716

GBP 1,299
EUR 1,869
USD 2,129

Limited places remaining

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

2-3 October 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13944

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 28 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.