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dinsdag 22 augustus 2017

Book your place now at the MHRA Variations Masterclass and Workshop

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Book your place now 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).

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.

Date
Monday 25 September 2017
Friday 24 November 2017

Venue
MHRA Head Office
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ

Time
09.00 -17.15

Programme

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

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