When: 28-29 June 2022
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, London, E14 9GE
Also available as a virtual course, please click here for the virtual registration option
This practical CRED workshop will explain the principles of the EU Variations Regulation. This workshop will also cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation. Other critical actions for effective lifecycle management will be discussed.
Managing lifecycle topics will include:
- Post-approval commitments
- Renewals and PSUR
- PRAC/CMDh recommendations
- Regulatory activities related to change in marketing status
- plus other topics
Variations topics will include:
- Overview of the key principles of Regulations (712/2012 amending 1234/2008) and variation guideline
- Variation Types, data requirements
- Experience sharing/Practical issues for submissions with focus on centralised procedure
- Future considerations: ICH Q12, Brexit etc.
- Variation procedures and their impact on strategy and implementation
Benefits to delegates
- Meet and learn from experts in the field
- Learn by doing- participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Take a course designed by professionals for professionals with a proven track record
- Get pointers about how to strategise the submission of variations to save money and avoid invalidation.
- Gain an up-to-date overview of variation classification and procedures in the EU.
CPD: This course provides 14.50 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Download the 2021 programme.
Past presenters have come from HPRA, MHRA, Gilead, TEVA, PPD and EMA.
- Less experienced regulatory affairs professionals
- Those who are going into the area of processing/ preparing/ submitting variations
- Regulatory Professionals who would like a refresher in the subject area
Simply log in or create an account and register below.
A limited number of discounted places are available at the rates below.
Please email us at firstname.lastname@example.org for a discount code before making your booking.
|Those working for regulatory agencies, government agencies or academic institutions
|Those working for charities, patient groups or in full-time education
*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