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News Archive
EMA - CTIS - New Version of the Sponsor Handbook
25th January 2022Ahead of the go-live date of 31st January 2022, EMA have published a Sponsor Handbook.
EMA - Global regulators discuss path towards regulatory alignment on response to Omicron variant
25th January 2022Global regulators discuss path towards regulatory alignment on response to Omicron variant
EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022
25th January 2022Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
25th January 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
EMA - Open for Comments Guideline on the acceptability of names for human medicinal products processed through the centralised procedure
25th January 2022In December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website.
EMA - Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
25th January 2022Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
FDA - FDA publishes 2021 Year in Review
25th January 2022FDA Year in Review 2021
MHRA Consultation on proposals for legislative changes for clinical trials
17th January 2022The MHRA are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help make the UK the best place to research and develop safe and innovative medicines.
REGISTRATION OPEN - EMA - Invitation to the webinar launch event for the Regulatory Science Research needs
12th January 2022Invitation to the webinar launch event for the Regulatory Science Research needs on 18 January 2022
EMA - EMA public consultation: ICH harmonised guideline on Quality Risk Management Q9 (R1)
22nd December 2021The European Medicines Agency has published for public consultation on the ICH harmonised guideline on Quality Risk Management Q9 (R1).
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