News

MHRA seminar - last call for places

Published on 20 January 2011

The MHRA have made a last call for delegates to join their seminar in London on 28 January, entitled The New Variations Regulation - One Year on. Further details, taken from their mailling, are below;

The New Variations Regulation
One Year on Seminar

This event, to be held in London on 28 January 2011, will be the optimal time to assess how both industry and Regulatory Authorities have adapted to the new Regulation. This event will reflect on experience to date, provide an update on developments arising from Co-ordination Group for Mutual Recognition and Decentralised procedures (CMDh) as well as give an opportunity to clarify current guidance.

Why attend?

There are major benefits for industry if the new Regulation is used effectively – lower waiting queues for filing variations, clearer requirements, more flexibility and efficient management of post approval changes. This event is an opportunity to learn about current updates and gather insights from MHRA experts that will assist to improve working practices and compliance.

Benefits of attending:

  • Learn from the mistakes and successes of other organisations
  • Improve your organisation’s efficiency and facilitate rapid approval of variations
  • Learn how to submit better quality submissions first time, through examples of good practice at the event
  • Gain a greater understanding of requirements and MHRA expectations
  • Opportunity to meet, network and share experiences with colleagues and regulator

Topics to be covered include:

  • Principles of the new variations Regulation and reminder of new industry responsibilities
  • Available guidance
  • First Year’s Experience and lessons learnt from processing both European and National variations
  • Procedural and practical aspects
  • Clarification of areas of concern
  • Type IA notifications – common deficiencies
  • Latest European developments, including experience with worksharing and Article 5 procedures
  • Groupings
For further information visit mhra.gov.uk/mhra/conferences

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