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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.

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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New Booklet Available

23rd September 2014

Quality in Research - Guidelines for working in non-regulated research The aim of this updated Guideline is to facilitate the stepwise and straightforward development of a value adding Quality System into any research institute. We have, in this second edition tailored our approach to help make the case for implementation essentially a 'no brainer'. In each section, we now review the risks posed by poor systems of work and exemplify, with real life examples or case studies, the consequences of non-robust research process. The potential steps which can then be taken to overcome such issues are highlighted, drawing on the original Guidelines as a basis, and then we indicate the additional benefits that good process often brings.

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Revised draft - OECD Draft Advisory Document 16 - The Application of GLP Principles to Computerised Systems

18th September 2014

The revised draft OECD DRAFT ADVISORY DOCUMENT 16- THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS Document has been posted today on OECD’s public website, and members of the public are invited to comment by 14 November, 2014. This new document will replace the 1995 OECD GLP Consensus Document number 10 - The Application of the Principles of GLP to Computerised Systems. You may of course comment independently but RQA will be sending a response so would be happy to incorporate any comment and as such please send them to RQA email address - info@therqa.com

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European Commission adopts proposals on veterinary medicinal products and medicated feed

11th September 2014

On 10 September 2014 the European Commission adopted proposals on veterinary medicinal products and medicated feed. With its proposal on veterinary medicinal products, the Commission aims to tailor legislation on veterinary medicinal products to the needs of the veterinary sector, without jeopardising public and animal health, or a safe environment.

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New recruitment opportunity added to the website

11th September 2014

QA Manager - DNDi Geneva, Switzerland

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EU Notified Body plans program of surprise audits

27th August 2014

As many as 300 unannounced audits of medical device manufacturers around the world are being planned by BSI Group, and a spokeswoman for the company said the goal is for every BSI client to have had at least one surprise inspection within the next two years. BSI, which is a notified body for CE-marked medical devices, is instituting the audits to comply with new EU medical device safety requirements. Clinical (subscription required) (8/19)

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Update to Guidance for UK manufacturer’s licence and manufacturer’s authorisation (for investigational medicinal products) holders on the use of stand alone contract laboratories

27th August 2014

An updated version of "Guidance for UK manufacturer's licence and manufacturer's authorisation (for investigational medicinal products) holders on the use of stand alone contract laboratories" has been issued.

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EMA - Pharmacovigilance Update

18th August 2014

This Update is the first in a series of documents primarily aimed at providing marketing authorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to come. Update documents will be issued quarterly.

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OECD GLP guidance on archiving documents

18th August 2014

MHRA GLP guidance on archiving documents has been withdrawn in favour of the OECD GLP advisory document No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP. The advice and guidance in the OECD document is essentially the same as the MHRA document and does not introduce any additional expectations.

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EMA Pharmacovigilance Manual - Version 1.1

4th August 2014

Pharmacovigilance Manual version 1.1 available

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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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