Series of half day events, to be held in MHRA head office in London on 5th and 6th February 2015 will provide instruction on using the new 'CCC' scheme for Composite Coordinated Collections published on the MHRA’s website that is an outcome of the Red Tape Challenge. This is a one-stop-shop allowing the coordinated submission and assessment of multiple parallel variations and PIQU applications which impact on the SmPC and label/patient information leaflet. One beneficial feature of the CCC scheme is the ability to submit one consolidated label/leaflet mock-up covering all changes applied for within a CCC application. Additionally the seminar gives an opportunity to clarify current guidance on variations grouping and PIQU submissions to make best use of current flexibilities and newly published MHRA guidance.
This is a must attend event for all those working in regulatory affairs and those involved in submitting variations to marketing authorisations - book your place now to avoid disappointment!
The events will be held at MHRA Head Office, London.
For more information about other MHRA events please visit the conference and education section of the MHRA website: www.mhra.gov.uk.
MHRA have appointed Glasgows to organise the events and host the online registration process. If you have any questions or require assistance with your registration please contact Glasgows via email: firstname.lastname@example.org or telephone: 01772 767778.