Membership is open to all those with an interest in the quality and integrity of scientific research and development and those working with, or interested in, Good Laboratory, Clinical or Manufacturing Practice regulations or Pharmacovigilance, be they from industry, government, academia or contract research and wherever in the world they are based.
Welcome to the RQA website
As an Association dedicated to informing and advancing its members, we provide status and visibility for individuals concerned with the quality of research in pharmaceuticals, agrochemicals, chemicals and medical devices. Since its beginnings in 1977, the Association has grown and developed to reflect regulatory changes, the impact of regulatory inspection and the changing structure and needs of industry. RQA's purpose is to drive quality and integrity in scientific research and development.
RQA 2016 Annual Conference
The 2016 RQA Annual Conference will be held at the Hilton Hotel Brighton during the 9-11 November 2016.
Latest News Items
Improving safety of first-in-human clinical trials
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.
Public consultation on 'Risk proportionate approaches in clinical trials'
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.