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News Archive
MHRA to resume on-site inspections
22nd March 2021In line with current Government advice, the inspectorate will resume an on-site UK risk-based GxP inspection programme from 29 March 2021.
MRC Article - Identifiability, anonymisation and pseudonymisation
22nd March 2021MRC - Identifiability, anonymisation and pseudonymisation article on Guidance note 5.
RSI in Clinical Trials: MHRA Findings and Tips
22nd March 2021RSI in Clinical Trials: MHRA Findings and Tips - from Safety Observer
What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
22nd March 2021An interesting article written by Harry Mingay and Dr. Rita Hendricusdottir on the classification of IVD devices taken from Oxford Global Guidance.
eClinical Forum - eCF Requirements PR2020
22nd March 2021ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
EMA - Veterinary Big Data Stakeholder Forum
10th March 2021EMA is pleased to announce a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1-2 June 2021.
MHRA - Pharmacovigilance inspection metrics April 2019 to March 2020
3rd March 2021MHRA have published Pharmacovigilance inspection metrics April 2019 to March 2020.
EMA - Highlights from CVMP Meeting 16-17 Feb 2021
23rd February 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021
EMA - Highlights from PRAC Meeting 8-11 Feb 2021
23rd February 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
EMA - Technical workshop on real-world metadata for regulatory purposes
23rd February 2021On behalf of the HMA-EMA Big Data Steering Group we are pleased to inform you of the upcoming “Technical workshop on real-world metadata for regulatory purposes” on Monday, 12 April 2021.
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