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woensdag 6 september 2017

Last few places remaining at the MHRA Variations Masterclass and Workshop

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Last few places remaining at the MHRA Variations Masterclass and Workshop

This event will give a hands-on experience with both presentations and workshops geared to enable a clear understanding of how to effectively prepare and submit a range of quality and clinical variations which include the grouping of variations, the worksharing procedure, and how to coordinate variations with changes to packaging, labelling and PIL's (PIQU changes) via the Composite Coordinated Collection' scheme (CCC).

Book now so you don't miss out

Why attend?

  • Hear about the Agency's experiences with variations, grouping, worksharing and Composite Co-ordinated Collections (CCC).
  • Gain insight and advice from agency assessors on how to submit smarter variations and how to avoid invalidation issues, Notification With Grounds letters and how to 'get it right first time'
  • Two workshops on quality and clinical variation scenarios, each split into two syndicates (12 delegates per syndicate) covering grouping of variations, 'CCC', Worksharing and Art. 61(3) procedures
  • Ask the panel of experts your regulatory questions on variations and PIQU applications.

Monday 25 September 2017
Friday 24 November 2017

MHRA Head Office
151 Buckingham Palace Road

09.00 -17.15


25 September 2017
£350.00 + VAT
24 November 2017 (this is a repeat)
£350.00 + VAT

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