CRED: Life Cycle Management - Variations

Aims and Course Content

‘The new Commission Regulation (EC) No 1234/2008 issued on 24th November 2008 for variations applies from 1st January 2010 to products approved via the Mutual recognition, Decentralised and Centralized procedures. The scope is further broadened to include nationally registered products via Directive 2009/53/EC issued on 18th June 2009 such that they comply from 20th January 2011. This revised practical CRED workshop will look into the principles of the new Regulation for variations and the new types of variation (IAIN, IA, IB and II). The workshop will cover the new procedures on grouping, worksharing and the guidelines on categorisation. The use of Type IAIN ‘annual reports’ and the involvement of CMD(h) 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. The day will include a practical workshop based around a case study where attendees will be split into small groups to work upon possible real life examples of how to use and interpret the new variation regulation and guidelines. This is an essential workshop for all companies operating within the European Union with marketing authorizations for human and veterinary products.

Who should attend?

• The less experienced Regulatory Professional who requires comprehensive information on a subject
• The experienced professional who is a newcomer to a particular regulatory aspect
• Anyone who wishes to update their knowledge in a particular subject area.

Speakers

Speakers include Sonia Ribeiro of the EMEA, Merete Schmiegelow, Novonordisk,
Denmark and Krystyna Fielden, Senior Pharmaceutical Assesor, MHRA, UK