Introduction to Veterinary Pharmacovigilance (London, United Kingdom - May 2-3, 2018)

  • ID: 4395106
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: May 2-3, 2018
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This course has been designed to provide basis training and a good introduction to those concerned with Veterinary Pharmacovigilance. New entrants, support staff we well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will be plenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject.

Benefits in attending:

  • Gain an overview of the European regulatory framework
  • Be aware of Volume IXb
  • Learn about VICH
  • Understand adverse event reporting
  • Hear about causality assessment
  • Minimise the impact of data with errors
  • Know the requirements for periodic safety update reports
  • Literature searches explained
  • Understand the implications of the proposed EU pharmacovigilance legislation and Brexit

Includes: Interactive workshop session

* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Programme Day One

Welcome and Introduction

What is Pharmacovigilance?

  • Beneficial and harmful effects of veterinary medicinal products
  • Key definitions

The Current Regulatory Framework and its Global Impact

  • Overview of European regulatory framework, including Volume IXb and implications of the proposed EU pharmacovigilance legislation
  • Implications for global environment – link to VICH
  • Practical applications of definitions

Adverse Event Reporting

  • Definitions
  • Impact of VICH guidelines
  • Expedited vs periodic
  • How to handle animal SARS
  • Understanding the wider scope of pharmacovigilance

Causality Assessment

  • The principles of causality assessment with practical examples
  • Medical evaluation of individual reports of adverse events
  • Strategies for follow up

Pharmacovigilance Case Studies

Programme Day Two

Electronic Communication in Pharmacovigilance (including VEDDRA)

Minimising the Impact of Data with Errors

Clincal Trial ADR Reporting Requirements

Literature Searches

Periodic Safety Update Reports

  •     Format and content of the PSUR
  •     Analysis of data
  •     Incidence calculation
  •     Compliance and the PSUR
  •     Addendum Reports
  •     Bridging Reports

Practical Workshops on PSURs

Discussion will take place throughout the two days

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  • Declan O'Rourke Mr Declan O'Rourke,
    Director ,
    Ortec Consultancy

    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 Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

    He is Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Senior President of British Cattle Veterinary Association and a member of the Veterinary Residues Committee and the Veterinary Products Committee (VPC).

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This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers together with regulatory affairs and personnel from registration departments will find this useful.     seminar                                                                                                                                                                                                                                                              

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The Cavendish Hotel
81 Jermyn Street
United Kingdom

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