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CMD(h) Report Progress report

CMD(h) Report Progress report. Truus Janse-de Hoog HMA meeting Budapest 28-29 April 2011. Statistics 2010/2011 Training new Members GCP IWG-CMDh mandate Future of CMDh New Pharmacovigilance legislation. Contents. Discussed in meeting of the HMA TF on resources, 2 March in Uppsala

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CMD(h) Report Progress report

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  1. CMD(h) ReportProgress report Truus Janse-de Hoog HMA meeting Budapest 28-29 April 2011

  2. Statistics 2010/2011 Training new Members GCP IWG-CMDh mandate Future of CMDh New Pharmacovigilance legislation Contents

  3. Discussed in meeting of the HMA TF on resources, 2 March in Uppsala CMDh will work together with TF and contribute to discussion on how Decentralised procedures can work better. In addition: CMDh will contribute to following topics - CMDh new tasks in relation with Pharmacovigilance legislation - Paediatric Worksharing - ad hoc group on ASMF- presented by Christa Wirthumer Concrete target suggested for implementation: reduction in number of referrals CMDh contribution to implementation on HMA Strategy 2011-2015

  4. Percentage of procedures referred in MRP since 2006

  5. Percentage of procedures referred in DCP since 2006

  6. Number of procedures Q1 2011/2010

  7. Article 45 – waves 1- 11 Updated on 11 April 2011

  8. Article 46* Worksharing per Number of Studies until end of March 2011 * Art. 46 Rapporteurs appointed by the CMDh Secretariat according to the BPG Art. 46 Updated on 11 April 2011

  9. In April for first time training new members organised with help of experienced members and CMD secretariat 13 participants: BU,BE,CY,DE,PT,RO,SL Topics: Task and mandate CMDh, organisation of meetings, Paediatric Worksharing, PSUR Worksharing, organisation of work at national agencies: acting as CMS and RMS Training new members

  10. Representatives of CMDh and GCP meet regularly to discuss GCP related issues in relation with MRP/DCP applications Annual programme for Risk based approach for routine Inspections of the CRO’s most often used for BE trials Guidance paper for cooperation and communication on outcome of inspections Proposal for Mandate CMDh-GCP IWG

  11. The group will coordinate and monitor an annual risk based programme of routine inspections of the CRO’s most often used in conduct of BE trials The group will communicate the outcome of GCP inspections on a routine basis to CMDh. In case of a negative outcome of Inspection a summary report will be presented to CMDh Mandate GCP-CMDh subgroup (1)

  12. The group will be involved in the development of Guidance papers, procedures and templates to facilitate exchange of information To provide a forum for discussion for GCP inspectors and assessors of scientific issues of common interest (eg triggers for inspection) To give feedback to the GCP IWG and CMDh Question to HMA: Can they endorse this mandate? Mandate GCP-CMDh subgroup (2)

  13. Other topics for discussion: Should CRO’s that have never been inspected always been inspected before granting marketing authorisation? No resources available at EU level for these inspections, some MSs regard this a potentially risk to public health Training needed to enlarge group of inspectors for BE trials Eudract shows that only limited number of MSs have performed Inspections on BE trials CMDh-GCP IWG

  14. WP on Future CMDh will continue to meet and discuss Implementation plans, eg from TF of self-medication New topics Update on Rules of procedure CMDh Implementation of new Pharmacovigilance requirements WP on Future of CMDh

  15. Mandate Responsible to WP on the future of CMDh to assist CMDh in the practical implementation of the new pharmacovigilance legislation To identify tasks and measures required by CMDh in readiness for the new legislation To propose a workplan to ensure that all necessary work is undertaken Ensure good liaison with the EMA/MS project teams, Project Coordination group and ERMS TF on implementation of PhVWP legislation

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