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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 GxP Data Integrity Guideline for consultation

24th July 2016

This consultation document (PDF, 207KB, 14 pages) provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.

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QA Manager - CrownBio

20th July 2016

A new opportunity has been added to the website - QA Manager at CrownBio

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New recruitment opportunity - Senior Director Regulatory Compliance

17th July 2016

A new recruitment opportunity added to the website

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Improving safety of first-in-human clinical trials

7th June 2016

The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union (EU). The review will identify which areas may need to be revised in the light of the tragic incident which took place during a Phase I first-in-human clincial trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalisation of five others.

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Public consultation on 'Risk proportionate approaches in clinical trials'

7th June 2016

Objective of the consultation With this public consultation the Directorate General for Health and Food Safety, DG SANTE, intends to seek the views of stakeholders – and other interested parties - on the document regarding "Risk proportionate approaches in clinical trials" which has been developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014. The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.

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Medical devices: deal reached on new EU rules

26th May 2016

On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices. The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

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EU Data Protection Regulation 2016/679 27 April 2016 repealing Directive 95/46/EC (General Data Protection Regulation)

9th May 2016

EU Data Protection Regulation 2016/679 27 April 2016 repealing Directive 95/46/EC (General Data Protection Regulation)

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Recruitment opportunity added to website

5th April 2016

A new recruitment opportunity has been added to the website - Senior QA Advisor

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New recruitment opportunity

10th March 2016

A new recruitment opportunity with Pfizer added to the website

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New recruitment opportunity added

25th February 2016

A new recruitment opportunity has been added to the website with Charles River

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New rules to help fight falsified medicines

15th February 2016

New rules approved by the European Parliament will require safety features on the packaging of medicines at risk of falsification

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