Advanced Veterinary Pharmacovigilance

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

23-24 Jun 2020

& 25-26 Nov 2020

GBP 1,399 1,199 *
EUR 1,959 1,679 *
USD 2,182 1,870 *
* When you book before 10 Apr

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 One

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 Two

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 & 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)

Practical and interactive discussion sessions will take place throughout the two days

Presenter

Declan O'Rourke

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

23-24 Jun 2020
23-24 Jun 2020 Holiday Inn London - Kensington Forum, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 10 Apr*
Enrol now
25-26 Nov 2020
25-26 Nov 2020 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

* 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
  • Bayer Pharmaceuticals
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health
  • Centauri Biotech
  • DADA Consultancy
  • DADA Consultancy BV
  • David Collins
  • Dechra Ltd
  • Delaval NV
  • Dyntec sro.
  • Elanco Animal Heallth
  • FATRO S.p.A
  • Grünenthal GmbH
  • Interchemie werken "De Adelaar" B.V
  • Interchemie Werken De Adelaar Eesti AS
  • Kepro B.V.
  • Merial
  • MERIAL - Comptabilité Fournisseurs
  • MERIAL- GROUPE BOEHRINGER INGELHEIM
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd.
  • Orion Corporation Orion Pharma
  • Pharmacosmos
  • Pharmacosmos A/S
  • PharmAdvice
  • SCP.KANGA-OLAYE & ASSOCIES
  • Sofus Regulatory Affairs
  • Veterinary Medicines Directorate
  • VRe Consulting Limited

It was overall a good course.

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

Excellent, well organised

Nathalie Frontczak, QPPV, Boehringer Ingelheim

Brilliant content and great speaker.

Danny Wise, Administrative Officer, Veterinary Medicines Directorate

An excellent course well presented

David Collins, Veterinarian, David Collins

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

Andrea Smith, Pharmacovigilance Team Leader, Boehringer Ingelheim Animal Health GmbH

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

Increase the number of practical/field examples. Very, very good. I like Declan's way to present and teach.

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

Useful for my daily tasks

Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate

Very knowledgeable and friendly expert!!!

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

I am very pleased to participate in the 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

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

Jennifer Blenkinsop, Pharmacovigilance VRO, Veterinary Medicines Directorate

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

Good.

Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate

It is good course, covers major topics in PV.

Shahid Soomro, Head of Scientific Department , Bremer Pharma GmbH

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

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

Great speaker, very informative.

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

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

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy

Great course and great speaker

Luis Marinas Pardo, Chief Scientific Officer, Centauri Biotech

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.

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

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

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

Anu Miettinen, Drug Safety Expert, Oy Medfiles Ltd.

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

Caroline Mullen, Pharmacovigilance Officer, Boehringer Ingelheim

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

Lynne Braidwood, Lead Monitor, Veterinary Clinical Studies, Triveritas