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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 Apr 2022

& 5-6 Jul 2022 , 18-19 Oct 2022

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Details

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.

Programme

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

Presenter

Declan O'Rourke (More...)

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.

Book now

Book now

26-27 Apr 2022
Live webinar
26-27 Apr 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 22 Mar 22*
Enrol now
to attend
Live webinar
5-6 Jul 2022
Face-to-face, (venue not yet confirmed)
5-6 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 1,399 1,199
EUR 1,959 1,679
USD 2,182 1,870
Until 31 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
18-19 Oct 2022
Live webinar
18-19 Oct 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 13 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • ACD Pharmaceuticals
  • Animal and Plant Health Agency
  • Animlacare
  • Bayer
  • BOEHRINGER INGELHEIM - ANIMAL HEALTH FRANCE
  • Boehringer Ingelheim Danmark AS
  • Boehringer Ingelheim Vetmedica GmbH
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • Dechra Veterinary Products Deutschland GmbH
  • DONAL DONNELLY
  • DR. E. GRAEUB AG
  • Eco Animal Health Group plc
  • Greveling Holding BV
  • Grovet BV
  • Huvepharma NV
  • Knowledgepool Group Limited
  • MERIAL- GROUPE BOEHRINGER INGELHEIM
  • Pharmacovigilance Matters Limited
  • Pharmaq
  • PHARMAQ AS
  • Pharmaxim AB
  • Scanvacc AS
  • Schippers Europe B.V.
  • Swedish Medical Products Agency
  • Versele-Laga
  • Vetcare Oy
  • Veterinary Medicines Directorate
  • Zoetis Deutschland GmbH
  • ZOOPAN S.A.

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

Aimee Wright, R & D Manager (Agricultural), EVANS VANODINE INTERNATIONAL PLC, Apr 21

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, Apr 21

Covered everything I currently need.

George Winthorpe, GxP Quality Assurance Auditor, Animal and Plant Health Agency , Oct 20

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 20

Good course.

Sean O'Sullivan, Bimeda Animal Health Ireland , Oct 20

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 20

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, Nov 19

In general very interesting course.

Guy Werquin, Veterinary Doctor, Versele-Laga, May 19

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

Tom Decock, Regulatory Affairs, Versele-Laga, May 19

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 19

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 19

[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 19

interesting, experienced speaker, great overview of pharmacovigilance.

Karen Roels, Clinical Trial Manager, Huvepharma NV, Nov 18

Enjoyed method of presenting.

Lisa Glen, Project Manager, Benchmark Animal Health, Nov 18

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

Lars Speilberg, Manager R&D, Scanvacc AS, Nov 18