Advanced Veterinary Pharmacovigilance

Advanced Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.

13-14 Mar 2019

& 1-2 Oct 2019

GBP 1,399
EUR 1,959
USD 2,182

Book now

Course Overview

Volume IXb is the new key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company. It will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products and its impact on pharmacovigilance.

Why you should attend

PROGRAMME TO INCLUDE

  • Overview of European regulatory framework
  • PV Training
  • Product Safety Review
  • 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 course 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 course run by Management Forum. Adverse event monitoring and drug safety offices together with regulatory affairs and personnel from registration departments will find this seminar useful.

Programme Day One

09.00 Registration and Coffee

09.30 Welcome and Introductions

The DDPS and the PV Master File

  • The DDPS
  • The DDPS – What happens now
  • The PV Master File – purpose and maintenance
  • Transition from DDPS to PV Master File

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, what to exclude in CSDS
  • Maintenance & development of CSDS

Compliance and PV

  • Basic principles
  • Measuring compliance
  • Quality versus quantity in safety reports

17.00 End of Day One

Programme Day Two

09.00 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 & 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

16.30 End of Day Two

Presenter

Declan O'Rourke (13-14 Mar 2019)

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 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

13-14 Mar 2019
13-14 Mar 2019 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
1-2 Oct 2019
1-2 Oct 2019 Venue not yet confirmed GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AB Science
  • ACD Pharmaceuticals AS
  • Bayer Pharmaceuticals
  • Beaphar B.V.
  • Benchmark
  • Benchmark Vaccines Limited
  • Boehringer Ingelheim
  • Boehringer Ingelheim Vetmedica GmbH
  • Bremer Pharma GmbH
  • Centauri Biotech
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • Dechra Ltd
  • Delaval NV
  • Dyntec sro.
  • Eco Animal Health Group plc
  • G.A.B.A. S.r.l.
  • Interchemie werken "De Adelaar" LT
  • Interchemie Werken De Adelaar Eesti AS
  • Kepro B.V.
  • Merial Norden A/S
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd.
  • Orion Corporation Orion Pharma
  • SCP.KANGA-OLAYE & ASSOCIES
  • Sofus Regulatory Affairs
  • Triveritas
  • Vetcare Oy
  • VRe Consulting Limited
  • Zoetis

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

Useful for my daily tasks

Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate

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 knowledgeable and friendly expert!!!

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

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

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, Pharmacovigilance - AO, Veterinary Medicines Directorate

Good.

Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate

Great speaker, very informative.

Jamie Jardine, Pharmacovigilance - AO, Veterinary Medicines Directorate

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

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy

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

Caroline Mullen, Pharmacovigilance Officer, Boehringer Ingelheim

Great course and great speaker

Luis Marinas Pardo, Chief Scientific Officer, Centauri Biotech

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

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

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

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

Anu Miettinen, Drug Safety Expert, Oy Medfiles Ltd.