Advanced Veterinary Pharmacovigilance

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.

11-12 Dec 2019

& 23-24 Jun 2020 , 25-26 Nov 2020

GBP 1,399
EUR 1,959
USD 2,182

Book now

Course Overview

This could will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products as well as Brexit and their impact on pharmacovigilance.

Programme to include:

  • Overview of European regulatory framework n The DDPS and the PV Master File
  • PV training
  • Product safety reviews
  • Company core safety information
  • Compliance and PV
  • PV reporting in licensing/distribution agreements
  • Signal detection
  • Benefit-risk assessments
  • Risk management
  • Crisis management
  • Implications of the proposed EU pharmacovigilance legislation

Who should attend

This seminar will be beneficial to those who have some experience of veterinary pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance, which is also run by Management Forum. Adverse event monitoring and drug safety officers, including QPPVs and Deputy QPPVs, together with personnel from regulatory affairs and registration departments will find this seminar useful.

The course can be used as part of the training to become a QPPV or Deputy QPPV.

Programme Day One

The DDPS and the PV Master File

  • The DDPS
  • The DDPS – what happens now
  • The PV Master File – purpose and maintenance
  • Transition from DDPS to PV Master File

PV Training

  • Requirements for PV training
  • Who trains whom and when?
  • Training records, maintenance and updates
  • Role of QA and HR in training

Product Safety Reviews

  • The Safety Review Committee
  • Timings for Safety Review
  • Record keeping for Safety Review meetings

Company Core Safety Information

  • Core safety information
  • How to determine what to include and what to exclude in CSDS
  • Maintenance and development of CSDS

Compliance and PV

  • Basic principles
  • Measuring compliance
  • Quality versus quantity in safety reports

Programme Day Two

PV Reporting in licensing/distribution agreements

  • What types of Agreements exist?
  • Audits of pharmacovigilance capabilities in partners
  • What agreements need to be in place for PV reporting?
  • PV reporting agreements – what needs to be covered?
  • Monitoring PV agreements – what happens if it goes wrong?

Signal detection/benefit risk and risk management

  • The pharmacovigilance system
  • Signal detection and analysis: what is required?
  • Benefit-Risk assessments
  • Risk management/minimisation
  • Crisis Management
  • Communication with the Public

Audits & Inspections: are you ready?

  • What are inspectors looking for?
  • Inspection findings and outcomes

Discussion will take place throughout the two days


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.

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

11-12 Dec 2019
11-12 Dec 2019 Rembrandt Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
23-24 Jun 2020
23-24 Jun 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now
25-26 Nov 2020
25-26 Nov 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AB Science
  • Bayer Pharmaceuticals
  • Beaphar B.V.
  • Benchmark Vaccines Limited
  • Billev farmacija vzhod d.o.o
  • Boehringer Ingelheim Animal Health
  • Centauri Biotech
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • David Collins
  • Dechra Ltd
  • Delaval NV
  • Dopharma Research BV
  • Dyntec sro.
  • Interchemie werken "De Adelaar" B.V
  • Interchemie Werken De Adelaar Eesti AS
  • Kepro B.V.
  • Merial
  • MERIAL - Comptabilité Fournisseurs
  • MSD Animal Health SRL
  • Orion Corporation Orion Pharma
  • Oy Medfiles Ltd.
  • PharmAdvice
  • Scan Aqua AS
  • Sofus Regulatory Affairs
  • VRe Consulting Limited
  • Zoetis
  • Zoetis Deutschland GmbH

Good speaker, up to date materials and plenty of case studies. Excellent and very clear course, well delivered with plenty of opportunity for interactive discussion.

Ruth Clements, Head of Pharmacovigilance, Benchmark

Increase the number of practical/field examples. Very, very good. I like Declan's way to present and teach.

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

I am very pleased to participate in the veterinary pharmacovigilance training by an expert in the field. The course materials were very well presented and the organization of the training course was perfect.

Hyun Jung HAN GANNEAU, Pharmacovigilance Associate (Vet), AB Science

Content was appropriate for the course title, it is a great follow on from basic training. Clear presentation, good clear slides, + Declan is always articulate + has a good way of explaining things especially when room is full of non native english speakers.

Jennifer Blenkinsop, Pharmacovigilance VRO, Veterinary Medicines Directorate

Useful for my daily tasks

Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate

Very knowledgeable and friendly expert!!!

Anna Sinjuk, Regulatory Affairs Specialist, Interchemie Werken De Adelaar Eesti AS

Very thought provoking, many topics covered in detail, very friendly staff. Plenty of reading for me to do afterwards

Nadine Anderson, Pharmacovigilance VRO, Veterinary Medicines Directorate

Great speaker, very informative.

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

It is good course, covers major topics in PV.

Shahid Soomro, Head of Scientific Department , Bremer Pharma GmbH

Knowledgeable presenter with a lot of experience, nice to have regulators amongst us.

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy

I think the course is presented in a brilliant manner and contains great informative content.

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate


Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate

Great course and great speaker

Luis Marinas Pardo, Chief Scientific Officer, Centauri Biotech

Speaker speaks well and was open to our questions and concerns.

Anu Miettinen, Drug Safety Expert, Oy Medfiles Ltd.

Content – good. Presentation and speaker - good presenting and discussion over issues raised by delegates

Lynne Braidwood, Lead Monitor, Veterinary Clinical Studies, Triveritas

Interesting, engaging and very useful. I will be recommending it

Caroline Mullen, Pharmacovigilance Officer, Boehringer Ingelheim

Overall, I think it was a very complete course, presented in an orderly and clean fashion. The speaker was very open for discussion and presented the course very lively.

Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.

There was a lot of examples and experiences told. Speaker was very available.

Tina Mele, Independent Researcher Drug Safety, KRKA d.d. Novo mesto