When: 17 October 2019
Where: TOPRA, 3 Harbour Exchange, London, E14 9GE
Time: 09:00 – 17:00 BST
Course overview
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
Benefits to delegates
- 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
- Understand the different approaches to extension variations and how variation referral procedures operate
- Understand the strategic aspects of variations, how to balance the time until approval against the cost and resources
- Learn by doing - participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Meet and learn from experts in the field
- Take a course developed by professionals, for professionals - with a proven track record
CPD: This course provides 8 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
The latest programme can be downloaded here.
Presenters
Beate Gasser - Austrian Federal Office for Safety in Health Care - BASG (Austria)
Wiebke Godow - Federal Office of Consumer Protection and Food Safety - BVL (Germany)
Gavin Hall - VMD
Luisa Pachés - Cyton Biosciences (UK)
Kevin Yount - Bayer Animal Health (Germany)
Suitable for
- 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
Pricing
Course *fees:
| Type |
Member |
Non-member |
| Standard |
£550+VAT |
£675+VAT |
Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
|
Those working for regulatory agencies, government agencies or academic institutions
|
£412.50+VAT
|
£506.25+VAT |
Those working for charities, patient groups or in full-time education
|
£275+VAT |
£337.50+VAT |
|
*VAT, if applicable, is charged at the rate of 20%
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Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions