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Presented by
Management Forum

Advanced Veterinary Pharmacovigilance Training Course

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

★★★★★ "Excellent and engaging content using some 'real life' examples which offered context for greater ins... more (44)"

2-3 July 2024
+ 9-10 October 2024 »

from £1099

Need help?  Enrol or reserve

Course overview

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. The programme will also consider the potential impact of Brexit on pharmacovigilance and the implications of the proposed EU Regulation (2019/6) on Veterinary Medicinal Products.

Interactive sessions throughout the two days will give delegates the opportunity to discuss key issues of current concern with our experienced trainer.

Programme to include:

  • Overview of European regulatory framework
  • The key requirements of Volume IXB
  • The detailed description of the pharmacovigilance system (DDPS) and the pharmacovigilance system master file (PSMF)
  • 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

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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 event useful.

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

Enrol or reserve

The Advanced Veterinary Pharmacovigilance course will cover:

The DDPS and the PSMF

  • The DDPS
  • The DDPS – what happens now?
  • The PSMF – purpose and maintenance
  • Transition from DDPS to PSMF

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 a company core data sheet (CCDS)
  • Maintenance and development of a CCDS

Compliance and PV

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

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 and inspections: are you ready?

  • What are inspectors looking for?
  • Inspection findings and outcomes
  • Implications of the proposed EU pharmacovigilance legislation

Risk Management Dealing with an Alert

Enrol or reserve

Declan O'Rourke
ORTEC PV Consultancy Ireland Ltd

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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

2-3 July 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13792

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 28 May

View basket 

Not ready to book yet?

for 7 days, no obligation

9-10 October 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13952

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 04 Sep

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Advanced Veterinary Pharmacovigilance training course

Excellent and engaging content using some 'real life' examples which offered context for greater insight, delivered by an experienced presenter who was able to provide additional depth when further questions were asked. I thoroughly enjoyed it thank you!

Oct 18 2023

Claire Francis
LRRP and Regulatory Affairs Officer, Vetoquinol UK Ltd

Oct 18 2023

Every item, but especially the topics of signal management & audits and inspections. I am grateful for the advise giving on how to approach audits/inspections.

Charlotte Lindorf Eriksen
Head of Pharmacovigilance, QPPV, Billev Pharma ApS

Nov 21 2022

Extremely satisfied to have participated in this training. The information shared will be very useful for improving the management of the PV system. The speaker's experience is intended to spark a debate on the management of PV operations following the entry into force of Regulation 2019/6. Declan is a perfect trainer.

Alessio Giannelli
Regulatory Science Liaison, Inovet

May 4 2022

Great for anyone looking to build on their PV Vet knowledge - for beginners and more experienced PV professionals especially in line with the new EU Veterinary Regulations

Oluwafemi Odugbesan
Boehringer Ingelheim Vetmedica GmbH

May 4 2022

Great content and discussion. Very good presentation style... Very worthwhile presentation

Justine Campbell
Senior Technical Services Veterinaria, QBiotics

May 4 2022

Declan is an excellent speaker and gave a good presentation.

Brendan Moran
Technical Director, Hygeia

Nov 24 2021


Hind Almaneaa
Pharmacovigilance specialist , PharmaKnowl Consulting

Nov 24 2021

The course covered all the areas I needed but it was the practical experience shared by the speaker that provided most valuable both in relation to engagement and understanding of the content...was filled with relevant, current experience between companies and regulators.

Serenia Horgan
Head of Quality Assurance, TriviumVet

Jun 23 2021

This was a very valuable course which I would highly recommend to other professionals in the industry. I couldn't have asked for a better speaker to be honest. I found Declan very honest and forthcoming with information and opinions. He provided clear and concise responses to any queries (I had a few haha) and was very approachable. The presentations were thorough and it was clear that a lot of effort was put in to ensure that all areas were covered. The webinar organisation and customer service is fantastic. Staff are extremely attentive and a pleasure to deal with.

Kiera Hamilton
Pharmacovigilance Manager, Norbrook Laboratories Limited

Nov 24 2021

Best you can get from a webinar. Speaker as well tried to motivate the audience to give input, does not always work but thats not up to speaker.

Eva-Maria Karg
Regulatory Affairs Specialist, Boehringer Ingelheim RCV GmbH & Co KG

Jun 23 2021

Very informative. The course lived up to all my expectations.

Marianne Valentin Hansen
Drug Safety Specialist, Pharmacosmos

Nov 25 2020

I really enjoyed the webinar and Declan did a really really good job! I really appreciated all the cases and examples he gave to us of his own experience.

Julia Urich
Veterinarian, Richter Pharma AG

Nov 25 2020

The webinar was very well organized. We got all needed information in advance, the speaker was amazing and the presentation focused on all aspects of PV.

Jan Subert
New Business Development Manager, Cymedica s.r.o.

Nov 25 2020

Not easy to make such 2 days-training not face 2 face, but the sharing of a lot of examples, and experiences kept my focus on !

Fanny Bellebeau-Barbier
Local responsible of pharmacovigilance, Boehringer Ingelheim

Nov 25 2020

Very good

Tone Madsen
Regulatory Affairs Manager / QPPV, Pharmaq AS, part of Zoetis

Nov 25 2020

Good, enjoyed it and learned a lot.

Lisa Glen
Project Manager, Benchmark Animal Health

Nov 25 2020

Very Good. Excellent topic and well prepared.

Sean O'Sullivan
Bimeda Animal Health Ireland

Nov 25 2020


Gaultier Purper
QP, Reprobiol SPRL

Nov 25 2020

I am very happy for having joined the course and for getting very good materials (presentations) and references from it, very didactic.

Maria Bermudez Espinosa
Doctor, LETI

Dec 11 2019

I really enjoyed this course. The interactions with other participants and the flexibility of the speaker to engage in real-world scenarios helped to put the course content into perspective. It was nice to know that other companies face similar challenges, and get practical solutions and advice from the speaker.

Amanda Dwyer
Pharmacovigilance Manager, North America, Elanco Animal Heallth

Mar 13 2019

Excellent, well organised.

Nathalie Frontczak
QPPV, Boehringer Ingelheim

Mar 13 2019

Brilliant content and great speaker.

Danny Wise
Administrative Officer, Veterinary Medicines Directorate

Mar 13 2019

The course was really useful, contained good information and moved at an appropriate pace.

Andrea Smith
Pharmacovigilance Team Leader, Boehringer Ingelheim Animal Health GmbH

Mar 13 2019

An excellent course, well presented.

David Collins
Veterinarian, David Collins

Mar 13 2019

Overall a good course.

Heetika Malik
QPPV, Interchemie werken "De Adelaar" B.V

Oct 2 2018

Excellent. The course was enjoyable, had lots of relevant examples and contained a variety of industry background which also added further benefits and learning opportunities, particularly through group discussions.

Jennifer Hynes
Site Head of Quality, Benchmark Vaccines Limited

Oct 2 2018

Very, very good. I liked Declan's way of presenting and teaching.

Luciano Gobbi
Associate Director Regulatory Affairs, MSD Animal Health SRL

Oct 2 2018

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

Mar 21 2018

I am very pleased to participate in this 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.

Pharmacovigilance Associate (Vet), AB Science

Mar 21 2018

Very knowledgeable and friendly expert!

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

Mar 21 2018

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

Jennifer Blenkinsop
Pharmacovigilance VRO, Veterinary Medicines Directorate

Mar 21 2018

Useful for my daily tasks.

Raffaella Focosi-Snyman
Pharmacovigilance HSO, Veterinary Medicines Directorate

Sep 26 2017

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

Mar 8 2017

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

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Mar 8 2017

It is good course, covers major topics in PV.

Shahid Soomro
Head of Scientific Department , Bremer Pharma GmbH

Mar 8 2017

Great speaker, very informative.

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Mar 8 2017

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

Angela van der Salm
Director Pharmacovigilance, DADA Consultancy

Mar 8 2017


Elisa Ursich
Pharmacovigilance - VRO, Veterinary Medicines Directorate

Sep 21 2016

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

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

Sep 21 2016

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

Caroline Mullen
Pharmacovigilance Officer, Boehringer Ingelheim

Sep 21 2016

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

Lynne Braidwood
Lead Monitor, Veterinary Clinical Studies, Triveritas

Sep 21 2016

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.

Sep 21 2016

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

Anu Miettinen
Drug Safety Expert, Oy Medfiles Ltd.

Sep 21 2016

Great course and great speaker

Luis Marinas Pardo
Chief Scientific Officer, Centauri Biotech

United Kingdom

  • Agrimin Ltd
  • Animalcare
  • Benchmark
  • benchmark Animal Health
  • Benchmark Vaccines Limited
  • Benchmark Vaccines Ltd
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health
  • Clinpharma
  • Collaborative Pharma Ltd
  • Cross Vetpharm Group UK Ltd
  • Cyton Biosciences Ltd
  • David Collins
  • Dechra Ltd
  • Eco Animal Health Ltd
  • Norbrook Laboratories Limited
  • Norbrook Laboratories Ltd
  • Triveritas
  • Veterinary Medicines Directorate
  • Vetoquinol UK Ltd
  • VRe Consulting Limited


  • Argenta Munich
  • Bayer AG
  • Bayer Animal Health
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim Vetmedica GmbH
  • Bremer Pharma GmbH
  • MSD Animal Health
  • MSD Animal Health Innovation GmbH
  • Zoetis Deutschland GmbH


  • Beaphar B.V.
  • Beaphar BV
  • DADA Consultancy
  • DADA Consultancy BV
  • Dopharma Research B.V.
  • Dopharma Research BV
  • Interchemie werken "De Adelaar" B.V
  • Kepro B.V.
  • Kepro BV
  • Le Vet Pharma


  • AB Science
  • Axience
  • Boehringer Ingelheim
  • Ceva Santé Animale
  • Merial
  • Merial - Boehringer Ingelheim


  • CID Lines
  • Delaval NV
  • Inovet
  • Reprobiol SPRL
  • Versele Laga NV
  • Zoetis


  • Billev Pharma ApS
  • Contura International A/S
  • Merial Norden A/S
  • Pharmacosmos
  • Pharmacosmos A/S
  • PharmAdvice


  • Centauri Biotech
  • Laboratorios Syva S.A.
  • Laboratorios Syva Sa
  • LETI
  • Vetpharm Ltd
  • Vetpharma Animal Health, S.L.


  • FATRO S.p.A
  • Fatro Spa
  • G.A.B.A. S.r.l.
  • MSD Animal Health SRL
  • Teknofarma S.r.l.


  • ACD Pharmaceuticals AS
  • Pharmaq AS
  • Pharmaq AS, part of Zoetis
  • Scan Aqua AS


  • Intervacc
  • Pharmaxim AB
  • Sofus Regulatory Affairs
  • The Swedish Medical Products Agency


  • Boehringer Ingelheim
  • Boehringer Ingelheim RCV GmbH & Co KG


  • Orion Corporation Orion Pharma
  • Oy Medfiles Ltd.
  • Vetcare Oy


  • Bimeda Animal Health Ireland
  • Hygeia
  • TriviumVet


  • Bayer Animal Health
  • QBiotics

Czech Republic

  • Cymedica s.r.o.
  • Dyntec sro.


  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • Owlpharma Consulting, Lda.


  • Billev farmacija vzhod d.o.o
  • KRKA d.d. Novo mesto


  • Primavet-Sofia


  • Elanco Animal Heallth


  • Interchemie Werken De Adelaar Eesti AS


  • Boehringer Ingelheim RCV GmbH & Co KG


  • Interchemie werken "De Adelaar" LT


  • Phibro Animal Health (Poland)

Saudi Arabia

  • PharmaKnowl Consulting


  • Bayer Pharmaceuticals

United States of America

  • Boehringer Ingelheim Animal Health

Enrol or reserve

Run Advanced Veterinary Pharmacovigilance Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749