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Introduction to Veterinary Pharmacovigilance Training Course: face to face & live webinar
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*
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 - day 1
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
Programme - day 2
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
| attend Face to face | attend Live webinar | ||||
| 14-15 Oct 2020, Rembrandt Hotel, London | |||||
| 14-15 Oct 2020 | Rembrandt Hotel, London |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 2 Sep* |
Enrol now
to attend Face to face |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 2 Sep* |
Enrol now
to attend Live webinar |
| 20-21 Apr 2021, Venue not yet confirmed | |||||
| 20-21 Apr 2021 | Venue not yet confirmed |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 9 Mar 21* |
Enrol now
to attend Face to face |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 9 Mar 21* |
Enrol now
to attend Live webinar |
| 12-13 Oct 2021, Venue not yet confirmed | |||||
| 12-13 Oct 2021 | Venue not yet confirmed |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 31 Aug 21* |
Enrol now
to attend Face to face |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 31 Aug 21* |
Enrol now
to attend Live webinar |
Learn more about our different training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
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- Registration of Animal Feed Additives in the EU
- How to Improve Accuracy and Attention to Detail
- Registration of Veterinary Vaccines in the USA and Canada
- Advanced Veterinary Pharmacovigilance
Previous customers include...
- ACD Pharmaceuticals
- Animal and Plant Health Agency
- Animlacare
- Aqua Pharma Group
- Bayer
- Benchmark Animal Health
- Boehringer Ingelheim Danmark AS
- Boehringer Ingelheim Denmark A/S
- Boehringer Ingelheim RCV GmbH & Co KG
- DADA Consultancy
- DADA Consultancy BV
- Eco Animal Health Group plc
- Grovet BV
- Huvepharma NV
- Jacobsen Pharma & MedTech Advice A/S
- Jurox Pty Limited (Australia)
- Knowledgepool Group Limited
- Norbrook Laboratories Ltd
- Pharmacosmos A/S
- Pharmacovigilance Matters Limited
- PHARMAQ AS
- Pharmaxim AB
- Scanvacc AS
- Seacalx AS
- SSCL Animal and Plant Health Agency
- Swedish Medical Products Agency
- Versele-Laga
- Vetcare Oy
- Veterinary Medicines Directorate
- ZOOPAN S.A.
“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
“[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
“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
“interesting, experienced speaker, great overview of pharmacovigilance.”
Karen Roels, Clinical Trial Manager, Huvepharma NV, Nov 18
“Well updated, easy to understand for a person with non-english mother tongue.”
Lars Speilberg, Manager R&D, Scanvacc AS, Nov 18
“Enjoyed method of presenting.”
Lisa Glen, Project Manager, Benchmark Animal Health, Nov 18
“Very good”
Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL, May 18
“Structured, logical and critical approach to a complex case handling. ”
Maud Christelle Ricatti, DVM, ACD Pharmaceuticals, May 18
“Interesting and informative course. Enthusiastic and informative speaker. ”
Hannah Robbins, Pharmacovigilance VRO, Veterinary Medicines Directorate, May 17
“Overall I was very impressed with the course”
Lee Smith, Pharmacovigilance E9O, Veterinary Medicines Directorate, May 17
“Very good”
Felicity Caddick, veterinary technical advisor, Animlacare, May 17
“Relevant, good course”
Katrine Underlien, Drug Safety Coordinator, Pharmacosmos, Nov 16