When: 3 October 2023
Where: Online
Time: 09:00–17:00 BST / 10:00-18:00 CEST
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
Click here for a copy of course programme.
Presenters
Presenters for this course include:
- Luisa Pachés - Knoell
- Melanie Anderson - Knoell
- Patrizia Oelker - Boehringer Ingelheim
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 |
Add membership to your booking to access the members' discount.
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%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions