Presented by
Management Forum

Introduction to Veterinary Pharmacovigilance

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 Apr 2022 + 2 more dates

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

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
  • Be aware of Volume IXb
  • Learn about VICH
  • Understand adverse event reporting
  • Hear about causality assessment
  • Minimise the impact of data with errors
  • Know the requirements for periodic safety update reports (PSURs)
  • Get to grips with literature searches
  • Understand the implications of the proposed EU pharmacovigilance legislation and Brexit

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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The Introduction to Veterinary Pharmacovigilance course will cover:

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, including Volume IXB and implications of the proposed EU pharmacovigilance legislation
  • Implications for global environment – link to VICH
  • Practical applications of definitions

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

  • Format and content of the PSUR
  • Analysis of data
  • Incidence calculation
  • Compliance and the PSUR
  • Addendum reports
  • Bridging reports

Practical workshop on PSURs

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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.

More details

Book Introduction to Veterinary Pharmacovigilance Live online/Classroom training

26-27 Apr 2022

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 11599

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 22 Mar

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5-6 Jul 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11405

  • GBP 1,199 1,399
  • EUR 1,679 1,959
  • USD 1,870 2,182

Until 31 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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18-19 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11725

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 13 Sep

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Reviews of IPI's Introduction to Veterinary Pharmacovigilance training course


Very informative and interesting webinar. Well explained by the speaker, who was very knowledgeable and experienced.

Apr 20 2021

Aimee Wright
R & D Manager (Agricultural), EVANS VANODINE INTERNATIONAL PLC

Apr 20 2021

I am pleased with the webinar. I feel like I learned a lot. For now I will try to get some real experience with writing PSUR and adverse events and then I would like to proceed with the advanced webinar on veterinary pharmacovigilance.

Natascha van Heugten-Cappelle
QPPV, Aesculaap BV

Oct 14 2020

Good course.

Sean O'Sullivan
Bimeda Animal Health Ireland

Oct 14 2020

Thoroughly enjoyed this 2-day interactive training course. Presentation content was very comprehensive and informative. Declan has a wealth of experience and shared practical knowledge/approach on how to handle common PV scenarios.

Oluwafemi Odugbesan
Boehringer Ingelheim Vetmedica GmbH

Oct 14 2020

Content: quite good. Too many abbreviations in the first two lectures, for newbies this is very frustrating. Presentation was way above expectations given the nature of it (webinar). Speaker also good, knew what he was talking about, mostly knew his audience and extreme level of intensity throughout the course.

Stian Mørch Aaen
Research Manager, Aqua Pharma Group

Oct 14 2020

Covered everything I currently need.

George Winthorpe
GxP Quality Assurance Auditor, Animal and Plant Health Agency

Nov 5 2019

Very informative, interactive course with room for questions and discussion. I learned a lot of practical things and points to consider.

Marjolijn Verweij-Heemskerk
Junior Consultant Pharmacovigilance, DADA Consultancy BV

May 15 2019

[The speaker was] enthusiastic, clear and easy to understand. The material was relevant and well explained.

Donal Donnelly
Clinical Veterinary Surgeon and Deputy QPPV, DONAL DONNELLY

May 15 2019

A good course to get a general introduction to Veterinary Pharmacovigilance, for those new to pharmacovigilance. The speaker, Declan O'Rourke, is very experienced and very enthusiastic in his presentation.

Anders Hessellund Bisgaard
QA & RA Assistant, Salfarm Danmark A/S

May 15 2019

Very good course. Personally I would have needed more time on PSURs and signal detection and less on cases assessment. Very informative and enthusiastic.

Claire Biener-Milard
Pharmacovigilance Manager, Merial - Boehringer Ingelheim

May 15 2019

Good general overview about pharmacovigilance. Talented and passionate speaker. Many practical examples.

Tom Decock
Regulatory Affairs, Versele-Laga

May 15 2019

In general very interesting course.

Guy Werquin
Veterinary Doctor, Versele-Laga

May 2 2018

Very good

Luciano Gobbi
Associate Director Regulatory Affairs, MSD Animal Health SRL

May 2 2018

Structured, logical and critical approach to a complex case handling.

Maud Christelle Ricatti
DVM, ACD Pharmaceuticals

Nov 7 2018

Well updated, easy to understand for a person with non-english mother tongue.

Lars Speilberg
Manager R&D, Scanvacc AS

Nov 7 2018

Enjoyed method of presenting.

Lisa Glen
Project Manager, Benchmark Animal Health

Nov 7 2018

interesting, experienced speaker, great overview of pharmacovigilance.

Karen Roels
Clinical Trial Manager, Huvepharma NV

May 3 2017

Overall I was very impressed with the course

Lee Smith
Pharmacovigilance E9O, Veterinary Medicines Directorate

May 3 2017

Very good

Felicity Caddick
veterinary technical advisor, Animlacare

May 3 2017

Interesting and informative course. Enthusiastic and informative speaker.

Hannah Robbins
Pharmacovigilance VRO, Veterinary Medicines Directorate

Nov 1 2016

Very interesting program, well organized, with a very experienced speaker, with good presentation technique and with a good ability to capture the interest of the participants. the presentations were clear and interesting.

Marlene Delgado
QPPV, ZOOPAN S.A.

Nov 1 2016

I think that this course is great for people looking for more insight into pharmacovigilance and would recommend it

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Nov 1 2016

Relevant, good course

Katrine Underlien
Drug Safety Coordinator, Pharmacosmos

Nov 1 2016

Good knowledge sharing, open dialogue, not all slides in the binder up to date, overall very positive

Angela van der Salm
Director Pharmacovigilance, DADA Consultancy

UK

  • Animal and Plant Health Agency
  • Animlacare
  • Benchmark Animal Health
  • Boehringer Ingelheim Denmark A/S
  • DONAL DONNELLY
  • Eco Animal Health Group plc
  • EVANS VANODINE INTERNATIONAL PLC
  • IAHJ - International Animal Health Journal
  • Knowledgepool Group Limited
  • Norbrook Laboratories Limited
  • Norbrook Laboratories Ltd
  • Pharmacovigilance Matters Limited
  • SSCL Animal and Plant Health Agency
  • TBC
  • Veterinary Medicines Directorate

Netherlands

  • Aesculaap B.V.
  • Aesculaap BV
  • Avimedical BV
  • Beaphar BV
  • DADA Consultancy
  • DADA Consultancy BV
  • Greveling Holding BV
  • Grovet BV
  • Schippers Europe B.V.

Norway

  • ACD Pharmaceuticals
  • Aqua Pharma Group
  • Pharmaq
  • PHARMAQ AS
  • Scanvacc AS
  • Seacalx AS

Denmark

  • Boehringer Ingelheim Danmark AS
  • Jacobsen Pharma & MedTech Advice A/S
  • Pharmacosmos
  • Pharmacosmos A/S
  • Salfarm Danmark A/S

Belgium

  • Huvepharma
  • Huvepharma NV
  • Inovet
  • Versele-Laga

France

  • Boehringer Ingelheim
  • Merial - Boehringer Ingelheim
  • Triveritas France

Germany

  • Boehringer Ingelheim Vetmedica GmbH
  • Dechra Veterinary Products Deutschland GmbH
  • Zoetis Deutschland GmbH

Sweden

  • Pharmaxim AB
  • Swedish Medical Products Agency

Australia

  • Jurox Pty Limited (Australia)

Austria

  • Boehringer Ingelheim RCV GmbH & Co KG

Finland

  • Vetcare Oy

Ireland

  • Bimeda Animal Health Ireland

Italy

  • MSD Animal Health SRL

Portugal

  • ZOOPAN S.A.

Switzerland

  • DR. E. GRAEUB AG

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy