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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

21-22 Nov 2022

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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

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


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 (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.

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.

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NEW higher discounts for booking multiple places - 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
21-22 Nov 2022
Live webinar
UK (London)
21-22 Nov 2022
Live webinar
UK (London)
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 17 Oct*
Enrol now
to attend
Live webinar

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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

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...

  • AB Science
  • Bayer Animal Health
  • Bayer Pharmaceuticals
  • Benchmark
  • benchmark Animal Health
  • Benchmark Vaccines Limited
  • Bimeda Animal Health Ireland
  • Boehringer Ingelheim Animal Health
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Clinpharma
  • Cross Vetpharm Group UK Ltd
  • Dopharma Research B.V.
  • Dopharma Research BV
  • Grünenthal GmbH
  • Interchemie werken "De Adelaar" LT
  • Intervacc
  • Kepro B.V.
  • MSD Animal Health Innovation GmbH
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd
  • Norbrook Laboratories Ltd.
  • Owlpharma Consulting, Lda.
  • PharmAdvice
  • PharmaKnowl Consulting
  • Pharmaq AS
  • Scan Aqua AS
  • Teknofarma S.r.l.
  • TriviumVet
  • Vetcare Oy

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

Justine Campbell, Senior Technical Services Veterinaria, QBiotics, May 22

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 22

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, Nov 21


Hind Almaneaa, Pharmacovigilance specialist , PharmaKnowl Consulting, Nov 21

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, Nov 21

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, Jun 21

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

Marianne Valentin Hansen, Drug Safety Specialist, Pharmacosmos, Jun 21

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 20

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 20

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, Nov 20


Gaultier Purper, QP, Reprobiol SPRL, Nov 20

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 20

Very Good. Excellent topic and well prepared.

Sean O'Sullivan, Bimeda Animal Health Ireland , Nov 20

Good, enjoyed it and learned a lot.

Lisa Glen, Project Manager, Benchmark Animal Health, Nov 20

Very good

Tone Madsen, Regulatory Affairs Manager / QPPV, Pharmaq AS, part of Zoetis, Nov 20