28th October 2016
A new recruitment opportunity has been added to the website Premier Research - Senior Auditor for Quality Assurance, Risk, and Compliance
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”.
18th September 2016
Research and Pre-Clinical Quality Senior Manager, Rixensart, Belgium
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.
7th September 2016
Metrics from pharmacovigilance inspections carried out annually.
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.
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
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:
1st August 2016
We have added a new recruitment opportunity to the website, GCP Quality Assurance Manager.
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.
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.