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

Join the Twitter conversation at #MHRAvariations
09:00 - 09:30

Registration and refreshments

09:30 - 09:40

Welcome & Introduction

CCC a Red Tape Challenge Initiative

Elizabeth Baker, Group Manager, Licensing Division, MHRA

09:40 - 10:00

The new CCC scheme - overview and using the MHRA procedural guidance

Krystyna Fielden, Unit Manager, PLAT 2 Licensing Division , MHRA

10:00 - 10:20

How to compile your CCC application and the assessment process

Elena Razzano, Pharmaceutical Assessor PLAT 4 Licensing Division , MHRA

10:20 - 10:35

How to submit a CCC application to the MHRA

Rachel Hyde, Delivery Manager, Information Processing Unit, IMD, MHRA

10:35 - 11:10

MHRA and industry experiences from the initial pilot trial

Elena Razzano, Licensing Division, MHRA

Michelle Riddalls, Pfizer Consumer Healthcare (PAGB)

Mor Ben-Adiva Mylan (BGMA)

Marion Berthelemy

11:10 - 11:30

Refreshment break

11:30 - 11:50

PIQU submissions for CCC applications – coordinating approvals of mock-ups

Julia Coombs (Morning Session), Scientific Assessor, PIQU, VRMM

Jan MacDonald (Afternoon Session, Group Manager AIMS*, VRMM

11:50 - 12:10

Variations groupings: submitting groupings without the need for prior approval from the MHRA

Krystyna Fielden, Licensing Division, MHRA

Stephanie Millican, Unit Manager PASU**, VRMM

12:10 - 12:25

Questions, Panel discussion, industry experiences


Michelle Riddalls, Pfizer Consumer Healthcare

Mor Ben-Adiva , Mylan

MHRA Speakers

12:25 - 12:30

Seminar close

Liz Baker, MHRA

* Access and Information for Medicines and Standards Group

** Post-authorisation Signal Unit, Vigilance Intelligence and Research Group, VRMM

5th February : Session to be repeated 1:00 - 4.30 pm
6th February : Session to be repeated 09:00 – 12:30 pm