MONITORING TO GCP

							                 Good Clinical Practice Training – 22 June 2007

            The EU Directives on GCP 2001/20/EC and 2005/28/EC
              And UK Regulation on the Conduct of Clinical Trials
                    with investigational medicinal products.

09.00 Registration

09.30 Background and Development of Good Clinical Practice
      ICH and EU Directives 2001/20/EC and 2005/28/EC
      What is guidance? What is Law? - an overview of GCP Regulation.

10.45 Break

11.00 The U.K. Regulations – Medicines for Human Use (Clinical Trials) Regulations
      The three Statutory Instruments that are legal requirements in the UK for
      everyone working on clinical trials with investigational medicinal products:

        SI 1031 implemented 1st May 2004
        SI 1928 implemented 29 August 2006
        SI 2984 implemented 12 December 2006

        The implications of the two new amendments to the UK regulations (introduced
        in 2006) for sponsors and investigational sites

12.00 Ethics Committees
      Directive requirements
      Update on the UK ethics review system
      Proposed changes to the ethics review system in 2007.

12.45 Lunch

13.45 Informed Consent
      Directive requirements
      Legalities and documentation

14.30 Break

14.45 GCP Inspection
      Who are the Inspectors – and what are they looking for?
      Inspection preparation and survival!
      Trial Files and Essential Documents – the data trail
      Feedback from recent inspections

16.00   Close
Time and venue:
Between 9am and 4pm at Barnes Room, Education Suite, Queen Mary’s Hospital, London
SW15 5PN (map/ directions available on request).




About this training course:
Directive 2001/20/EC on GCP in Clinical Trials made Good Clinical Practice a legal
requirement in the EU from May 2004. The Medicines for Human Use (Clinical Trials)
Regulations 2004 (Statutory Instrument 1031) transposed this Directive into U.K. Law
from 1st May 2004. A second Directive on GCP, 2005/28 was published in April 2005
and this was transposed into U.K. Law on 29 August 2006 under Statutory Instrument
1928. A third Statutory Instrument (2984) was implemented with effect from 12
December 2006.

This one day course will provide all the latest information on the new regulations, guide
delegates through the regulations and offer practical advice on how the regulations
should be put into every day practice. This training day is of particular interest to
anyone working on clinical trials and related fields as well as Trust R & D personnel.

Course Objectives:
To ensure delegates are familiar with:

   the latest developments in Good Clinical Practice and understand the effects that
    the Directives have on current working practices within clinical research.
   The three Statutory Instruments that now form the U.K. regulations
   the proposed changes in the UK ethics review process (GAfREC) under the Warner
    Report and look at the implications for investigators and sponsor companies
   the additional requirements within the Directive in relation to consent, especially for
    ‘vulnerable groups’ and ‘Legal Representative’
   the audit/inspection process and the importance of the mandatory inspections that
    are now being conducted at sponsor premises and investigational sites by the
    Medicines and Healthcare Products Regulatory Agency (MHRA).

Prepared by Joan Perou
GCP Consultant and Trainer
April 2007




                    Funded by the London Development Agency
                    Good Clinical Practice Training – 22 June

             The EU Directives on GCP 2001/20/EC and 2005/28/EC
               And UK Regulation on the Conduct of Clinical Trials
                     with investigational medicinal products.

                                  BOOKING FORM

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                             Please return this form to:

                         Barbara Maguire, Administrator
                     Wandsworth Primary Care Research Centre
                                 Wandsworth PCT
                      Mapleton Centre, 88-92 Garratt Lane
                         Wandsworth, London, SW18 4DJ
                               Tel: 020 8812 5044
                               Fax: 020 8812 5048
                       Email: Barbara.maguire@wpct.nhs.uk