About

We are pleased to announce two dates for this event ‘The Variations Masterclass and Workshop’ which will provide a detailed overview for Regulatory Affairs staff responsible for the preparation and submission of both national and MR variations and Article 61(3) procedures (PIQU). 

The 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). Understand how to make better use of these procedures through examples of good practice. Learn how best to avoid invalidation issues, Notification With Grounds (NWG’s) letters and how to ‘get it right first time’ and improve your strategy for submitting multiple changes.

An additional Variations Masterclass will take place in early 2018 (date TBC)

Questions to the panel

Once you have registered, you have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. You will be issued with login details on your registration confirmation email. The team will endeavour to answer as many of these questions as they can at the event. Please include in your submission the name of the speaker you wish to address your question to.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.

Agenda

  • Registration & refreshments

  • Welcome and Introduction

    • Elizabeth Baker, Group Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • The variations system

    -       Basis
    -       Current challenges

    • Keith Pugh, Expert Assessor, CMDh subgroup, PLAT 6, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • Agency experiences (Quality):

    - rules for grouping and worksharing
    - applying a risk-based approach to your variation strategy
    - experiences shared

    • Dr Krystyna Fielden, Unit Manager, PLAT 2, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • Refreshments

  • Agency experiences (Clinical & PIQU)

    • Dr Stephanie Millican, Unit Manager, VRMM, Medicines and Healthcare products Regulatory Agency
    • Dr Julia Coombes, Manager, PIQU, VRMM, Medicines and Healthcare products Regulatory Agency
  • Using the CCC scheme to co-ordinate submission and assessment of variations and PIQU applications

    • Elena Razzano, Pharmaceutical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • Summary and instructions for the workshop

    • Elizabeth Baker, Group Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • Lunch break

    Groups of 4 syndicates (A, B, C & D)

  • Workshops

    • Keith Pugh, Expert Assessor, CMDh subgroup, PLAT 6, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Krystyna Fielden, Unit Manager, PLAT 2, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Elena Razzano, Pharmaceutical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Stephanie Millican, Unit Manager, VRMM, Medicines and Healthcare products Regulatory Agency
    • Dr Julia Coombes, Manager, PIQU, VRMM, Medicines and Healthcare products Regulatory Agency
    • Quality workshop

      Syndicate A & B

      Syndicate C & D

  • Workshops

    • Keith Pugh, Expert Assessor, CMDh subgroup, PLAT 6, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Krystyna Fielden, Unit Manager, PLAT 2, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Elena Razzano, Pharmaceutical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Stephanie Millican, Unit Manager, VRMM, Medicines and Healthcare products Regulatory Agency
    • Dr Julia Coombes, Manager, PIQU, VRMM, Medicines and Healthcare products Regulatory Agency
    • Clinical workshop

      Syndicates A & B

      Syndicates C & D

  • Feedback from delegates on the workshops with panel discussion

    B & D present back on the Clinical

    A & C present back on the Quality

    • Elizabeth Baker, Group Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Keith Pugh, Expert Assessor, CMDh subgroup, PLAT 6, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Krystyna Fielden, Unit Manager, PLAT 2, Licensing Division, Medicines and Healthcare products Regulatory Agency
    • Dr Stephanie Millican, Unit Manager, VRMM, Medicines and Healthcare products Regulatory Agency
    • Dr Julia Coombes, Manager, PIQU, VRMM, Medicines and Healthcare products Regulatory Agency
    • Elena Razzano, Pharmaceutical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency
  • Close

    • Elizabeth Baker, Group Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency

Meet The Speakers

Elizabeth Baker photo

Elizabeth Baker

Group Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency

Elizabeth Baker (Liz) is a pharmacist with an MSc in Biophar...
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Keith Pugh photo

Keith Pugh

Expert Assessor, CMDh subgroup, PLAT 6, Licensing Division, Medicines and Healthcare products Regulatory Agency


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Krystyna Fielden photo

Dr Krystyna Fielden

Unit Manager, PLAT 2, Licensing Division, Medicines and Healthcare products Regulatory Agency

Dr Krystyna Fielden is a pharmacist with a PhD in Pharmaceut...
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Stephanie  Millican photo

Dr Stephanie Millican

Unit Manager, VRMM, Medicines and Healthcare products Regulatory Agency

Dr Stephanie Millican joined the MHRA in 1996 following a ca...
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Julia Coombes photo

Dr Julia Coombes

Manager, PIQU, VRMM, Medicines and Healthcare products Regulatory Agency

Dr Julia Coombes completed her BSc in Physiology and PhD at...
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Elena Razzano photo

Elena Razzano

Pharmaceutical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency

Ms Elena Razzano is a pharmacist working as a Pharmaceutical...
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Venue

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

Register Your Interest

An additional meeting has been scheduled to take place on 19th March 2018. To register your interest in this event please enter your details and you will be contacted in due course when further information is available and when bookings are opened.

Register Your Interest

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