Advanced Veterinary Pharmacovigilance

Including the main requirements of Volume IXB, an update on the proposed EU regulation for veterinary medicinal products and the impact of Brexit

11-12 Dec 2019

& 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 20 Sep

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 implications of the proposed EU Regulation for Veterinary Medicinal Products as well as Brexit and their impact on pharmacovigilance.

Programme to include:

  • Overview of European regulatory framework
  • The key requirements of Volume IXB
  • The 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

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 CSDS
  • Maintenance and development of CSDS

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

Discussion 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

11-12 Dec 2019
11-12 Dec 2019 Rembrandt Hotel, 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 20 Sep*
Enrol now
23-24 Jun 2020
23-24 Jun 2020 Venue not yet confirmed GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
25-26 Nov 2020
25-26 Nov 2020 Venue not yet confirmed 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...

  • AB Science
  • ACD Pharmaceuticals AS
  • Beaphar B.V.
  • Benchmark
  • Billev farmacija vzhod d.o.o
  • Boehringer Ingelheim Animal Health
  • Bremer Pharma GmbH
  • Centauri Biotech
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • David Collins
  • Delaval NV
  • Interchemie werken "De Adelaar" B.V
  • Interchemie werken "De Adelaar" LT
  • Interchemie Werken De Adelaar Eesti AS
  • Kepro B.V.
  • MERIAL - Comptabilité Fournisseurs
  • Merial Norden A/S
  • MERIAL- GROUPE BOEHRINGER INGELHEIM
  • MSD Animal Health SRL
  • Orion Corporation Orion Pharma
  • Pharmacosmos A/S
  • PharmAdvice
  • Pharmaxim AB
  • SCP.KANGA-OLAYE & ASSOCIES
  • Triveritas
  • Vetcare Oy
  • Veterinary Medicines Directorate
  • VRe Consulting Limited
  • Zoetis

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

Excellent, well organised

Nathalie Frontczak, QPPV, Boehringer Ingelheim

It was overall a good course.

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

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

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

Very knowledgeable and friendly expert!!!

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

Useful for my daily tasks

Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate

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

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

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy

It is good course, covers major topics in PV.

Shahid Soomro, Head of Scientific Department , Bremer Pharma GmbH

Good.

Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate

Great speaker, very informative.

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

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

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

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.

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

Lynne Braidwood, Lead Monitor, Veterinary Clinical Studies, Triveritas

Great course and great speaker

Luis Marinas Pardo, Chief Scientific Officer, Centauri Biotech

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

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

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