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Recent News

If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.

A new recruitment opportunity has been added to the website

30th June 2014

Inspection Manager, Pfizer

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Global Unique Device Identification Database (GUDID): Guidance for Industry - now available

30th June 2014

The GUDID: Guidance for Industry is now available. For questions on the guidance document please contact the FDA UDI Help Desk at www.fda.gov

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New RQA Association Manager

25th June 2014

New RQA Association Manager We are pleased to announce the appointment of Anthony Wilkinson as RQA Association Manager. Anthony suceeds former Manager David Weller, now retired, to become only the second Association Manager in the RQA's 37-year history. Anthony has had a distinguished and varied career, with an established track record of leadership across a range of industries in UK, Europe, Middle East and Asia. He previously served as Chairman of the BPFWG Technical Committee, was an active member of the BPFWG Management Council, sat on several Regulatory committees and, in 2013, was appointed Chief Executive of the FMS.

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New recruitment opportunity on website

18th June 2014

A new recruitment opportunity has been added to the site

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New EU Clinical Trial Regulation Published

17th June 2014

New EU Clinical Trial Regulation Published

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New career opportunity on site - MHRA

4th June 2014

New career opportunity on the website - MHRA GPvP Inspector

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New Gold Standard Role Profile for Responsible Person

2nd June 2014

MHRA - Launch of new Gold Standard role profile for the Responsible Person Following extensive discussion with pharmaceutical companies and the MHRA, Cogent has published a new Gold Standard role profile for the Responsible Person, which sets out an industry-agreed framework thatidentifies the skills requiired by a Responsible Person in 4 skills areas.

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New Clinical Trials Regulation published

28th May 2014

The new Clinical Trials Regulatuion EU No. 536/2014 has been published

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MHRA - New legilation on Medical Devices

7th May 2014

Revision of the Medical Devices Directives All of the current legislation regulating medical devices is in the process of being revised at European level. This will replace the existing three European directives with two European regulations.

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MHRA - Risk-based inspection FAQ version 6

6th May 2014

MHRA - Risk-based Inspection Frequently Asked Questions - Version 6 (updated April 2014)

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Risk-based inspection FAQ version 6

6th May 2014

MHRA - Risk-based inspection Frequently Asked Questions - version 6 (updated April 2014)

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MHRA - GCP Inspections Metrics Report Published

30th April 2014

GCP inspections metrics report covering the period 1 April 2012 to 31 March 2013 has been published

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MHRA - Updated definition of a critical GCP inspection finding

28th April 2014

The GCP Inspectorate has updated their definition of a critical finding to include 'where provision of the Trial Master File (TMP) does not comply with Regulation 31A 1-3. as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations'.

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EU Council approves the Clinical Trials Regulation

22nd April 2014

The EU Council has approved the Clinical Trials Regulation. This formal adoption of the Regulation means that it will enter into force 20 days after publication in the Official Journal of the European Union.

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MHRA Business Plan for 2014-15

16th April 2014

The MHRA has published its Business Plan for 2014-15. This is an important document that sets out key work over the next year to progress their 2013-18 Corporate Plan and how they will respond to challenges and opportunities ahead.

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MHRA - Managing Medical Devices

14th April 2014

Guidance on managing reusable medical devices in hospitals and community based organisations

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EU Statement on Clinical Trials Regulation

2nd April 2014

Statement by Health Commissioner Tonio Borg following the vote in Parliament on the Clinical Trials regulation

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GCP Inspection Report Metrics

25th March 2014

MHRA Report covering the period 1 April 2011 to 31 March 2012 has been added to the Good Clinical Practice section

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MHRA and NHS England in initiative to simplify adverse incident reporting

25th March 2014

MHRA and NHS England have jointly issued two patient safety alerts and supporting guidance to help simplify reporting and help healthcare providers increase incident reporting involving medication errors and medical devices.

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MHRA - GCP Inspections Report

18th March 2014

GCP Inspections Metrics Report covering the period 1 April 2010 - 31 March 2011

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New career opportunity on website - QRC Consultants

17th March 2014

A new career opportunity has just been added to the website - GCP QA Consultant at QRC Consultants

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New career opportunity on Website - Bourn Hall Clinic

27th February 2014

Senior Quality Assurance Auditor and Quality Assurance Auditor - Bourn Hall Clinic near Cambridge

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EudraGMDP improves visibility of compliance

20th February 2014

Following the launch of EudraGMDP V5.1, GMP non-compliance statements can now be viewed by the public.

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MHRA new Clinical Director of Medical Devices

11th February 2014

The MHRA today announced that Dr Neil McGuire has been appointed as its new Clinical Director of Medical Devices with effect from 3rd March 2014

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EU Clinical Trial Regulation - NEW Webinar from RQA

10th February 2014

A new webinar from RQA is now available to purchase online. EU Clinical Trial Regulation: Where are we? The RQA GCP Committee offers a 'heads up' on some of the GCP aspects of the proposed Regulation (draft 20th December 2013). Some have heralded it as the biggest change to Clinical Trials since the EU Clinical Trials Directive (2001/20/EC). The EU is dramatically changing the law regarding clinical trials and plans to repeal the existing EU Directive 2001/20/EC.

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Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products

10th February 2014

The European Commission have launched the Public Consultation on the revision of Annex 15: Qualification and Validation. Stakeholders are invited to comment on this draft by 31st May 2014 at the latest

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New and revised Draft Guidances CDER is planning to publish during 2014

6th February 2014

CDER draft Guidances planned for 2014

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Good Pharmacovigilance Practice compliance report template now available

4th February 2014

MHRA - The risk-based inspection compliance report 2013 for Good Pharmacovigilance Practice is now available.

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EU Clinical Trial Regulation - Webinar from RQA

3rd February 2014

A new webinar from RQA is now available to purchase online. EU Clinical Trial Regulation: Where are we? The RQA GCP Committee offers a 'heads up' on some of the GCP aspects of the proposed Regulation (draft 20th December 2013). Some have heralded it as the biggest change to Clinical Trials since the EU Clinical Trials Directive (2001/20/EC). The EU is dramatically changing the law regarding clinical trials and plans to repeal the existing EU Directive 2001/20/EC.

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Regulatory Guidelines for Medicinal Products for Veterinary Use Volume 6B - Presentation and Content of the Dossier - January 2014

28th January 2014

Volume 6B gives guidance to applicants for marketing authorisations for veterinary medicinal products on the presentation of the data requirements and summaries of the dossier

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Bioresearch Monitoring (BIMO) metrics 2013

27th January 2014

Bioresearch Monitoring (BIMO) metrics for 2013 now available

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Q&A: Article 31 Pharmacovigilance referral

27th January 2014

This guidance addresses a number of questions which stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 31 referral resulting from the evaluation of data from pharmacovigilance activities.

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