MHRA variations seminars: new CCC scheme for co-ordinating variation and PIQU applications
5th & 6th February 2015

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Who Should Attend?

This conference is must attend event for all pharmaceutical companies and their agents involved in submitting variations to marketing authorisations and those involved in regulatory affairs.

Why attend?

There are major benefits for industry if the CCC scheme is used effectively - coordinated assessments of variations and PIQU applications, submission of one consolidated label/PIL mockup (reduced costs and timelines), more flexibility and efficient management of post approval changes. This event is an opportunity to learn about using new procedures, grouping changes more effectively and gather insights from MHRA experts that will assist to improve working practices and compliance.

Benefits of attending

  • Learn about using the CCC scheme to coordinate your variations and PIQU applications.
  • Improve your organisation’s efficiency in implementing SmPC and label/leaflet changes and facilitate rapid approval of variations.
  • Understand how to make better use of grouping variations through examples of good practice.
  • Discuss experiences gained with the CCC scheme during the pilot with MHRA experts and industry representatives.

Topics to be covered include

  • An overview of the new CCC scheme for the coordinated submission and assessment of multiple concurrent variations and PIQU applications.
  • How to use the MHRA’s published procedural guidance on CCC to submit an application– practical experiences and examples from the MHRA’s pilot phase.
  • Administrative and technical requirements for submitting a CCC application to the MHRA via the Sentinel portal or CESP.
  • Required content of a CCC application.
  • How to improve efficiency by grouping variations effectively.
  • Guidance on PIQU submissions.