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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.

UK EU Life Sciences Transition Programme

23rd September 2016

Following the outcome of the EU referendum, George Freeman MP, formerly Life Sciences Minister, announced the formation of the UK EU Life Sciences Steering Group to oversee and manage the transition for the life sciences sector and consider “how the UK can seize the opportunity to define a new relationship with the EU”.

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New vacancy added to website

18th September 2016

Research and Pre-Clinical Quality Senior Manager, Rixensart, Belgium

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New vacancy

8th September 2016

There are new vacancies on the recruitment area of our website, check them out if you're looking for a new opportunity.

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Pharmacovigilance inspection metrics, 2009 to present

7th September 2016

Metrics from pharmacovigilance inspections carried out annually.

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Good Laboratory Practice for Nonclinical Laboratory Studies

24th August 2016

The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System.

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European Commission publishes Pharmacovigilance Report

10th August 2016

On August 8, 2016, the European Commission (EC) announced the publication of a three-year report that highlights the collaboration between the European Medicines Agency (EMA), the EC, and European Union Member States in the implementation of pharmacovigilance legislation. The report emphasizes that the collaboration has “enhanced the monitoring of the safety of human medicines throughout their lifecycle, for the benefit of patients.” The report describes the activities of the EU system for monitoring drug safety from July 2012, when new pharmacovigilance legislation came into effect, until July 2015. According to EMA, the report shows that the new system has been successful at quickly detecting safety issues and is effectively engaging patients and healthcare professionals

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Clinical Trial Regulations - have your say

2nd August 2016

The Medicines and Healthcare products Regulatory Agency invites interested parties to provide feedback on Clinical Trial Regulation guidance documents. This consultation seeks the views of stakeholders – and other interested parties – on the document regarding “Risk proportionate approaches in clinical trials”. 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. There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014:

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New GCP recruitment opportunity

1st August 2016

We have added a new recruitment opportunity to the website, GCP Quality Assurance Manager.

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10th IMDRF Meeting in Brazil

31st July 2016

All interested parties are invited to attend DITTA Workshop on September 12th and International Medical Device Regulators Forum (IMDRF) Stakeholders Forum on September 14th. See Program Part for the details, including a brief description of the events. During these events, participants will be invited to discuss continuous improvements to device safety and performance, and emerging challenges in medical device regulation. Stakeholder input is important for global regulatory convergence, and the IMDRF Management Committee greatly appreciates your participation and contribution.

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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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