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Advanced Veterinary Pharmacovigilance Training Course: face to face & live webinar

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

25-26 Nov 2020

& 23-24 Jun 2021 , 24-25 Nov 2021

Book now

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

Programme - day 1

Overview of the European regulatory framework

  • The key requirements of Volume IXB

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

Programme - day 2

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

The implications of Brexit and new EU Regulation (2019/6)

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
25-26 Nov 2020, Cavendish Hotel, London
25-26 Nov 2020 Cavendish Hotel, London GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 14 Oct*
Enrol now
Limited places

to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 14 Oct*
Enrol now
Limited places

to attend
Live webinar
23-24 Jun 2021, Venue not yet confirmed
23-24 Jun 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 12 May 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 12 May 21*
Enrol now
to attend
Live webinar
24-25 Nov 2021, Venue not yet confirmed
24-25 Nov 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 13 Oct 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 13 Oct 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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Previous customers include...

  • ACD Pharmaceuticals AS
  • Beaphar B.V.
  • Benchmark
  • Billev farmacija vzhod d.o.o
  • Boehringer Ingelheim
  • Boehringer Ingelheim Vetmedica GmbH
  • Bremer Pharma GmbH
  • Centauri Biotech
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • Delaval NV
  • FATRO S.p.A
  • G.A.B.A. S.r.l.
  • Grünenthal GmbH
  • Interchemie werken "De Adelaar" B.V
  • Interchemie werken "De Adelaar" LT
  • Interchemie Werken De Adelaar Eesti AS
  • Le Vet Pharma
  • Merial
  • MERIAL - Comptabilité Fournisseurs
  • Norbrook Laboratories Ltd
  • Norbrook Laboratories Ltd.
  • Oy Medfiles Ltd.
  • Pharmacosmos A/S
  • PharmAdvice
  • Pharmaxim AB
  • Scan Aqua AS
  • Sofus Regulatory Affairs
  • Triveritas
  • Vetcare Oy

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, Dec 19

An excellent course, well presented.

David Collins, Veterinarian, David Collins, Mar 19

Excellent, well organised.

Nathalie Frontczak, QPPV, Boehringer Ingelheim, Mar 19

Brilliant content and great speaker.

Danny Wise, Administrative Officer, Veterinary Medicines Directorate, Mar 19

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 19

Overall a good course.

Heetika Malik, QPPV, Interchemie werken "De Adelaar" B.V, Mar 19

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, Oct 18

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

Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL, Oct 18

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 18

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 18

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 18

Very knowledgeable and friendly expert!

Anna Sinjuk, Regulatory Affairs Specialist, Interchemie Werken De Adelaar Eesti AS, Mar 18

Useful for my daily tasks.

Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate, Mar 18

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, Sep 17

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

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy, Mar 17