Response to TOPS

Please see link to letter by Richmond Pharmacology in response to the earlier TOPS article by Boyce et al.

Berelowitz et al A pan-European registration system for volunteer participation is within sight

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MHRA GCP Consultative Committee Meeting

The GCP inspectorate organises a GCP consultative committee with relevant interested parties, and answering any queries. For example, relating to GCP issues, GCP inspections and also parliamentary questions. The GCP Inspectorate holds symposia every year, in which updates from the inspection programme and new issues that may impact on the conduct of research (e.g. new legal requirements) are reviewed.

The AHPPI are collecting comments and queries from members to be raised at the next MHRA GCP Consultative Committee meeting. Please ensure that you provide your comments to info@ahppi.org.uk by 20 July 2012 so that we can compile an AHPPI document by the deadline of 10 August 2012.

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New AHPPI Committee

Following recent nominations there is a new committee. Malcolm stepped down as chair but John Kelly, Corinthia Joseph, Ulrike Lorch, Mike Hammond and Peter Dewland were returned for another term of office. A new member is welcomed in the form of  Keith Wesnes, a veteran of the CRO industry!  Welcome Keith.

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AHPPI has a new Chair

The new committee of AHPPI has elected Peter Dewland as their new Chairperson. Peter takes over from Malcolm Boyce who has ably held this role over the past years.  A huge debt of thanks is due to Malcolm who has guided AHPPI forward.  Peter hopes to be able to follow in his footsteps.

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HEALTH RESEARCH AUTHORITY

The new Health Research Authority has been launched this month.  For more information please see http://www.dh.gov.uk/health/2011/12/creation-hra/

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Presentations: Personalised Medicine – Will it work?

We are delighted to announce the availability of the presentations from our recent annual meeting.

They can be found by following this link.

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MHRA Updated Phase I Accreditation Scheme and Guidance

The AHPPI has collected members’ feedback for the MHRA on the updated Phase I guidance – which replaces the FAQs – and the consolidated comments document with the actions completed and the updated tracked changes proposal to update the Scheme itself, moving to a single type.

You can view the AHPPI response to MHRA Phase 1 Accreditation proposed changes.

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MHRA GCP FORUM

Please note that MHRA has launched its GCP Forum which can be accessed at:  http://forums.mhra.gov.uk/forumdisplay.php?1-Good-Clinical-Practice-(GCP)

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NRES NEWS

All NRES Training courses can be viewed on their website at

http://events.npsa.nhs.uk/nres

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