Course overview

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
• Variations
• Renewals and PSUR
• PRAC/CMDh recommendations
• Regulatory activities related to change in marketing status

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

Very informative and well structured. I'd recommend this course for someone new to Regulatory.”  – 2020 delegate

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. 

Programme

Presenters

Past presenters have come from Biogen, Gilead, Malta Medicines Authority, MHRA, , Pharmalex, TEVA and EMA. Presenters for this course will be announced closer to the start.

Suitable for

• 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

Pricing  

Standard

• Member: £925+VAT*
• Non-member: £1,095+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:
  • Members: £693.75+VAT*
  • Non-members:  £821.25+VAT*
• Those working for charities, patient groups or in full-time education:
  • Members: £462.50+VAT*
  • Non-members: £547.50+VAT*

Terms and conditions

Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.