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Introduction to Veterinary Pharmacovigilance Training Course: face to face

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*

12-13 Oct 2020

& 14-15 Oct 2020 , 20-21 Apr 2021 , 22-23 Apr 2021 , 12-13 Oct 2021 , 14-15 Oct 2021

Book now

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.

Declan 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 Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

Declan is also an Honarary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Past President of British Cattle Veterinary Association and a member of the Veterinary Products Committee (VPC).

Book now

Book now

12-13 Oct 2020
Face-to-face, Rembrandt Hotel London
12-13 Oct 2020
Face-to-face
Rembrandt Hotel London
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 31 Aug*
Enrol now
to attend
Face-to-face
Rembrandt Hotel London
  • 2 days of 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
14-15 Oct 2020
Live webinar
14-15 Oct 2020
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 2 Sep*
Enrol now
to attend
Live webinar
20-21 Apr 2021
Live webinar
20-21 Apr 2021
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 9 Mar 21*
Enrol now
to attend
Live webinar
22-23 Apr 2021
Face-to-face, (venue not yet confirmed)
22-23 Apr 2021
Face-to-face
(venue not yet confirmed)
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 11 Mar 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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
12-13 Oct 2021
Live webinar
12-13 Oct 2021
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 31 Aug 21*
Enrol now
to attend
Live webinar
14-15 Oct 2021
Face-to-face, (venue not yet confirmed)
14-15 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 2 Sep 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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

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

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
  • Bayer
  • Beaphar BV
  • Benchmark Animal Health
  • Boehringer Ingelheim Danmark AS
  • Boehringer Ingelheim Denmark A/S
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • Dechra Veterinary Products Deutschland GmbH
  • DR. E. GRAEUB AG
  • Eco Animal Health Group plc
  • Greveling Holding BV
  • Grovet BV
  • Huvepharma NV
  • Intervacc AB
  • Jacobsen Pharma & MedTech Advice A/S
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd
  • Pharmacosmos A/S
  • Pharmacovigilance Matters Limited
  • Pharmaxim AB
  • Salfarm Danmark A/S
  • Scanvacc AS
  • SSCL Animal and Plant Health Agency
  • Swedish Medical Products Agency
  • Triveritas Limited
  • Veterinary Medicines Directorate
  • Zoetis Deutschland GmbH

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 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, Norbrook Laboratories Ltd, 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

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

Maud Christelle Ricatti, DVM, ACD Pharmaceuticals, May 18

Very good

Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL, May 18

Interesting and informative course. Enthusiastic and informative speaker.

Hannah Robbins, Pharmacovigilance VRO, Veterinary Medicines Directorate, May 17

Very good

Felicity Caddick, veterinary technical advisor, Animlacare, May 17

Overall I was very impressed with the course

Lee Smith, Pharmacovigilance E9O, Veterinary Medicines Directorate, May 17

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 16