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.
★★★★★ "Very helpful, practical and of high quality."
9-10 October 2024
+ 13-14 February 2025, 24-25 June 2025, 15-16 October 2025 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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.
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.
Benefits of attending
- Explore the European regulatory framework and the implications of the proposed EU pharmacovigilance legislation
- Learn the key requirements of Volume IXB and a detailed description of the pharmacovigilance system (DDPS) and the pharmacovigilance system master file (PSMF)
- Gain PV training, PV reporting in licensing/distribution agreements and company core safety information compliance
- Understand product safety reviews, signal detection and benefit-risk assessments
- Look at risk management and crisis management
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.
This 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
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.
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
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)
Timings may be different for each day
Course code 13952
- GBP 1,299
- EUR 1,869
- USD 2,129
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
13-14 February 2025
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 14654
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 09 Jan
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
24-25 June 2025
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)
Timings may be different for each day
Course code 14792
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 20 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
15-16 October 2025
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)
Timings may be different for each day
Course code 14991
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 10 Sep
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
Very helpful, practical and of high quality.
Jul 2 2024
Delphine Decrouy 
Regulatory affairs Manager, Axience
Jul 2 2024
Great webinar, content and speaker
Janine Gavin 
Director, Collaborative Pharma Ltd
Jul 2 2024
Informative webinar. Recommend to those wanting to know/validate current industry practices/thinking.
Alesia Mitchell 
Associate Director, Global AH PV and RA Quality Standard, Boehringer Ingelheim Animal Health
Oct 18 2023
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!
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
Excellent
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
Excellent
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.
Hyun Jung HAN GANNEAU
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
Good.
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
- Animal and Plant Health Agency
- Animal and Plant Health Agency (APHA)
- 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
- Propharma Group
- Triveritas
- Veterinary Medicines Directorate
- Vetoquinol UK Ltd
- VRe Consulting Limited
Germany
- Argenta Global
- 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
Netherlands
- 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
France
- AB Science
- Axience
- Boehringer Ingelheim
- Ceva Santé Animale
- Merial
- Merial - Boehringer Ingelheim
- VIRBAC
Belgium
- CID Lines
- Delaval NV
- Inovet
- Reprobiol SPRL
- Versele Laga NV
- Zoetis
Denmark
- Billev Pharma ApS
- Contura International A/S
- Merial Norden A/S
- Pharmacosmos
- Pharmacosmos A/S
- PharmAdvice
Spain
- Centauri Biotech
- Laboratorios Syva S.A.
- Laboratorios Syva Sa
- LETI
- Vetpharm Ltd
- Vetpharma Animal Health, S.L.
Italy
- FATRO S.p.A
- Fatro Spa
- G.A.B.A. S.r.l.
- MSD Animal Health SRL
- Teknofarma S.r.l.
Norway
- ACD Pharmaceuticals AS
- Pharmaq AS
- Pharmaq AS, part of Zoetis
- Scan Aqua AS
Sweden
- Intervacc
- Pharmaxim AB
- Sofus Regulatory Affairs
- The Swedish Medical Products Agency
Austria
- Boehringer Ingelheim
- Boehringer Ingelheim RCV GmbH & Co KG
- RICHTER PHARMA AG
Finland
- Orion Corporation Orion Pharma
- Oy Medfiles Ltd.
- Vetcare Oy
Ireland
- Bimeda Animal Health Ireland
- Hygeia
- TriviumVet
Portugal
- Animalcare Group
- Hifarmax, Produtos e Serviços Veterinários, Lda.
- Owlpharma Consulting, Lda.
Australia
- Bayer Animal Health
- QBiotics
Czech Republic
- Cymedica s.r.o.
- Dyntec sro.
Slovenia
- Billev farmacija vzhod d.o.o
- KRKA d.d. Novo mesto
United States of America
- Boehringer Ingelheim Animal Health
- Zoetis
Bulgaria
- Primavet-Sofia
Canada
- Elanco Animal Heallth
Estonia
- Interchemie Werken De Adelaar Eesti AS
Hungary
- Boehringer Ingelheim RCV GmbH & Co KG
Lithuania
- Interchemie werken "De Adelaar" LT
Poland
- Phibro Animal Health (Poland)
Saudi Arabia
- PharmaKnowl Consulting
Switzerland
- Bayer Pharmaceuticals
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:
