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Regulatory Update: Veterinary Variations in the EU

Price

£675*

Location

London, United Kingdom

Date

17 Oct 2019

Reference No: T1907364-TOP

Apply for this event

Key points about this Training Event

  • Understand how variation procedures operate for VMPs, how best to do group changes and when work-sharing can be applied
  • Understand how to classify a variation and prepare an application for submission and understand the different approaches to extension variations and how variation referral procedures operate
  • Participate in case studies and interactive sessions whilst building a network to support the rest of your career
  • Meet and learn from experts in the field in attending a course developed by professionals, for professionals - with a proven track record
Event Description

Course Outline:

The course will cover:

  • The procedures and latest developments on grouping, work-sharing and the guidelines on categorisation
  • The use of Type IA ‘annual reports’ and the involvement of CMD(v)
  • The impact of development relating to the quality dossier
  • The safety, efficacy and development to Pharmacovigilance system

When & Where?

When:
17 October 2019 09:00 - 17:00

Where:
TOPRA Office
3 Harbour Exchange
London
E14 9GE

*Cost?

TOPRA Members £550.00 plus 20% VAT
TOPRA Non Members £675.00 plus 20% VAT

Applicant Requirements
  • Those who are working for organisations operating within the European Union with marketing authorisation for veterinary products
  • Those from human regulatory affairs, who want an understanding in how variations are managed in the veterinary sector
  • New regulatory personnel
Reference No: T1907364-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.

Email info@topra.org

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