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Essential Steps to Achieving Quality and Compliance - 14th October
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News Archive
EMA - CTIS Newsflash 25th February 2025
26th February 2025This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
UKRI - Report calls for action to tackle decline in clinical researchers
26th February 2025Urgent action is required to address falling numbers of clinical researchers and meet the needs of the nation’s health and economy, according to a new report
EMA - certification for its environmental efforts
24th February 2025Eco-Management and Audit Scheme (EMAS) certificate is a mark of environmental excellence in the EU
MHRA Blog - New Leadership and a focus on Software
24th February 2025Rob Reid, 21 February 2025
MHRA - Updates to PV Exceptions and Modifications Document
20th February 2025Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
EMA - CTIS Newsflash 11th Feb 2025
19th February 2025This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Clinical Trials Highlights Feb 2025
19th February 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
EMA - Human Medicines Highlights Feb 2025
19th February 2025The newsletter for patients, consumers and healthcare professionals
EMA - Regular procedure for scientific advice on certain high-risk medical devices
12th February 2025Manufacturers can request advice on their medical device clinical development programme
FDA - Institutional Review Board (IRB) Written Procedures
12th February 2025Guidance for Institutions and IRBs OHRP's and FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes OHRP's and FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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