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Make it Public: transparency and openness in health and social care research
3rd September 2020Why research transparency is important The UK has a thriving health and social care research environment. More people take part in research studies each year, and donations to medical research charities are on the rise. Health and social care research findings translate into better care for patients and service users, and improvements to our health and wellbeing. They also lead to economic growth. Scientific and medical publishing has become more open over recent years and new initiatives are driving towards research findings being ever more freely available. This is making research findings more accessible to researchers and others working in health and social care. However, the people who take part in research studies want to know about the findings of research too. Transparency about what research is going on, and what its findings are, is important for patients, service users and the public. It builds trust and accountability, acknowledges their contribution and encourages participation in research. It’s also essential for research and care professionals. It leads to improvements and avoids duplication of effort. It enables findings to be used to develop new and better treatments for patients and service users, and to identify the best ways for us to stay healthy and well. It also helps improve the quality of research. When research is carried out openly and transparently, everyone benefits: patients and the public can see what research is taking place or has completed, and access clear information about the results patients, service users and carers can find out about research that is relevant to them, giving them the opportunity to join studies health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions
ARSAC notes for guidance: good clinical practice in nuclear medicine
2nd September 2020Guidance on licencing and best use of radiopharmaceuticals and sealed radioactive sources in diagnosis, treatment or research.
EU: Checklist for Brexit Preparation
2nd September 2020The end of the transition period is approaching and no agreement is in sight. Having first published a Communication to prepare for the end of the transition period, the European Commission has now published a respective 'Brexit Readiness Checklist' for companies doing business with the UK. This checklist is designed to help EU companies doing business in the UK (United Kingdom; UK) and/or UK companies doing business in the EU to check exactly how well prepared they are for 1 January 2021.
MHRA - Brexit Transition
2nd September 2020Guidance for industry and organisations to follow from 1 January 2021 issued by the UK Government.
MHRA - Changes from 1st January 2021
2nd September 2020The MHRA have released lots of documents relating to Brexit and the changes that will need to implemented on 1st January 2021 so it is worth taking a look at their news area.
MHRA - List of approved countries for authorised human medicines from 1 January 2021
2nd September 2020Approved countries for batch testing and importation of medicines from 1 January 2021
MHRA - preparing to make submissions to the MHRA from 1 January 2021
2nd September 2020Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems to use from 1 January 2021.
Helping you navigate the world of medical device regulation
27th August 2020Oxford Global Guidance Helping you navigate the world of medical device regulation A digital tool to make it easier to understand how medical device regulations apply to your product.
RQA News - JSQA / RQA Collaboration Pharmacovigilance Quality Systems
27th August 2020Members Only Both Japan and the European Union have highly advanced and defined legislation and regulatory expectations for pharmacovigilance. JSQA and RQA have previously collaborated on an overview document for all pharmacovigilance requirements. In this collaboration an analysis of EU and Japan Quality Management Systems (QMS) to support pharmacovigilance as described in legislation and guidance documents is presented. In this collaborative exercise we provide a comparison of these requirements.
RQA News - PV Legislative Update
27th August 2020Members Only August 2020 Version
