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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

24-25 Nov 2021

& 1-2 Feb 2022 , 4-5 May 2022 , 1-2 Aug 2022 , 21-22 Nov 2022

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Details

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

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

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.

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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Book now

24-25 Nov 2021
Live webinar
24-25 Nov 2021
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 20 Oct*
Enrol now
Limited
places

to attend
Live webinar
1-2 Feb 2022
Face-to-face, (venue not yet confirmed)
1-2 Feb 2022
Face-to-face
(venue not yet confirmed)
GBP 1,399 1,199
EUR 1,959 1,679
USD 2,182 1,870
Until 28 Dec*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
4-5 May 2022
Live webinar
4-5 May 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 30 Mar 22*
Enrol now
to attend
Live webinar
1-2 Aug 2022
Face-to-face, (venue not yet confirmed)
1-2 Aug 2022
Face-to-face
(venue not yet confirmed)
GBP 1,399 1,199
EUR 1,959 1,679
USD 2,182 1,870
Until 27 Jun 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
21-22 Nov 2022
Live webinar
21-22 Nov 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 17 Oct 22*
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

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
  • ACD Pharmaceuticals AS
  • Bayer AG
  • Bayer Pharmaceuticals
  • Benchmark Vaccines Limited
  • Bimeda Animal Health Ireland
  • Bremer Pharma GmbH
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • DADA Consultancy BV
  • David Collins
  • Dechra Ltd
  • Delaval NV
  • Dopharma Research B.V.
  • Dopharma Research BV
  • Eco Animal Health Ltd
  • G.A.B.A. S.r.l.
  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • Interchemie Werken De Adelaar Eesti AS
  • LETI
  • Orion Corporation Orion Pharma
  • Oy Medfiles Ltd.
  • Pharmacosmos A/S
  • PharmAdvice
  • Reprobiol SPRL
  • RICHTER PHARMA AG
  • Scan Aqua AS
  • SCP.KANGA-OLAYE & ASSOCIES
  • Triveritas
  • VRe Consulting Limited

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

Excellent

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

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

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

Brilliant content and great speaker.

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

An excellent course, well presented.

David Collins, Veterinarian, David Collins, Mar 19