This course will cover the Commission Regulation (EC) No 1234/2008 for variations which has applied since 2010 to products approved via the Mutual recognition, Decentralised and Centralized procedures, and since January 2011 to nationally registered products via Directive 2009/53/EC.

This practical CRED workshop will look into the principles of the regulation for variations and the types of variation (IAin, IA, IB and II).

The workshop will cover the procedures and latest developments on grouping, worksharing and the guidelines on categorisation. The use of Type IA ‘annual reports’ and the involvement of CMD(v) will also be covered. The impact of changes relating to the quality dossier will be evaluated, and similarly the safety/ efficacy and changes to Pharmacovigilance system to be introduced will be reviewed. The potential impact on regulatory strategy and implementation will be considered.

This is an essential workshop for all companies operating within the European Union with marketing authorizations for veterinary products and is particularly useful to new regulatory personnel, or those from human RA who want to understand how variations are managed in the veterinary sector.

CPD

This course offers 5 CPD hours for successful completion

Why is Continuous Professional Development important?

As a professional in regulatory affairs you have a personal responsibility to maintain your level of knowledge and competence; you are therefore encouraged to participate in Continuous Professional Development.

CPD is important to you as; 

• It demonstrates to your employer that you have planned, updated and maintained your knowledge and experience.
• It enables you to develop your knowledge and experience for your present role and any potential future roles.

Course prices (including VAT):
Member: £510
Non-member: £600

Those working for regulatory agencies or government agencies or academic institutions: 
Member: £382.50
Non Member: £450 
For the 25% discount please contact meetings@topra.org for the code


Those working for charities, patient groups or in full time education:
Member: £127.50
Non Member: £150 
For the 75% discount please contact meetings@topra.org for the code

Please note the number of discounted places may be limited.
All fees are shown in Pounds Sterling and include VAT 

- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £100 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.