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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.

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

16th March 2015

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry.

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Use of Electronic Informed Consent in Clinical Investigations Questions and Answers Guidance for Industry

15th March 2015

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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Quality Assurance Associate

3rd March 2015

New vacancy on the recruitment area of the RQA website - Vernalis are looking to recruit a Quality Assurance Associate, see website for further details

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Another new recruitment opportunity - Pfizer - Director, Inspection Manager

26th February 2015

Pfizer are looking for a Director, Inspection Manager. Details on our recruitment page.

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New recruitment opportunity - Senior QA Advisor

25th February 2015

A new vacancy placed on our website, see our website for further details.

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New vacancy - Senior Specialist

24th February 2015

CSL Behring are looking to recruit, see RQA recruitment page for further details.

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Medical devices: conformity assessment and the CE mark

27th January 2015

How to conform with the legal requirements for placing medical devices on the market.

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Medical devices: guidance for manufacturers on vigilance

26th January 2015

Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.

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HRA and MHRA - Clinical Trial Regulation

22nd January 2015

HRA and MHRA welcome public consultation on application of transparency rules of EU Clinical Trial Regulation

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New recruitment position - Quality and Compliance Manager

15th January 2015

New position posted on the Recruitment section of our website - Quality and Compliance Manager

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Out of date information on new MHRA website

13th January 2015

The RQA GCP Committee have found a number of out of date GCP documents on the new MHRA website - www.gov.uk. The MHRA have advised that some documents may not be up to date compared with the old site - www.MHRA.gov.uk. but the GCP Inspectorate will review the documents in the GCP areas over the next few weeks to ensure that they are up to date. Click on Read more to visit the old site

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EMA - Functional specifications for the EU portal and EU database to be audited

23rd December 2014

The new Clinical Trial Regulation (EU) No 536/2014 (hereinafter “the Regulation) establishes a harmonised approach to submission, assessment and reporting of clinical trials (CTs) with theimplementation of consistent rules throughout the Member States (MSs). These processes are to be supported by a EU portal and EU database which will ensure a centralised workflow with monitoring by the relevant parties.

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New recruitment opportunity - QA/GCP Auditor

17th December 2014

PSI are looking for a QA/GCP Auditor, further details below

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EMA Classification and analysis good clinical practice (GCP) inspection findings of GCP inspections 01Dec2014 (Inspection reports to EMA (2000-2012)

12th December 2014

Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of the Committee for Medicinal Products for Human Use (CHMP)

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New recruitment opportunity - QA Manager - QASMC

10th December 2014

New recruitment opportunity on our website - see recruitment section for further details.

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Recently posted details of the FY2014 inspection observations

10th December 2014

Inspection Observations FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

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New Vacancy - QA Manager/Senior QA Auditor

5th December 2014

Celerion are looking for a QA Manager/Senior QA Auditor, details in recruitment section of our website.

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Department of Health triennial of arm's length bodies

2nd December 2014

The Department of Health (DH) reviews its arm's length bodies once every 3 years. This review is looking at what MHRA, the British Pharmacopeia and the Commission on Human Medicines do and how. DH has sent out a public call for evidence to support the reviews: Britsh Pharmacopeia Commission: triennial review Commission on Human Medicines: triennial review MHRA: triennial review

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New recruitment opportunity - GLP Inspector

2nd December 2014

New vacancy placed on our website - MHRA - GLP Inspector

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HRA Protocol template released for consultation in use

24th November 2014

In collaboration with a wide range of partners, the HRA has published a template and guidance for protocols for clinical trials of investigational medicinal products (CTIMPs). This is the first in a suite of templates for health research. The templates will be particularly valuable to new researchers, but the main aim is to provide clarity about the information that reviewers need to assess research projects, and that research teams need to conduct the project effectively.

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Major investment in life sciences

24th November 2014

New investment into life sciences announced alongside a review into how we develop medicines and medical technology.

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New recruitment opportunity - GCP Quality Specialist

7th November 2014

New opportunity added to the website - GCP Quality Specialist - Imanova

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New Recruitment Opportunity - Associate Director

3rd November 2014

A new recruitment opportunity has been added to the website. Associate Director, PPD

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Quality Assurance Manager

29th October 2014

Vacancy for Quality Assurance Manager, UCL Cancer Institute

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Office of Pharmaceutical Quality

22nd October 2014

Office of Pharmaceutical Quality officially launched. This is a new office within CDER that creates a single unit dedicated to product quality

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New recruitment opportunity added to website - Global CRO

16th October 2014

Senior QA Auditor - GCP - Global CRO

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Recruitment opportunity on website

9th October 2014

Manager, Quality Assurance - Harlan

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New OECD guidance on the requirements for peer review of histopathology

7th October 2014

The OECD working group on Good Laboratory Practice have published the advisory document Guidance on the GLP Requirements for Peer Review of Histopathology (external link) as part of the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring.

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