EMA - Highlights from CHMP 22-25 Feb 2021

22nd March 2021

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting.

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EMA - Management Board – highlights of March 2021 meeting

22nd March 2021

EMA Management Board – highlights of March 2021 meeting Share

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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021

22nd March 2021

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021

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MHRA to resume on-site inspections

22nd March 2021

In line with current Government advice, the inspectorate will resume an on-site UK risk-based GxP inspection programme from 29 March 2021.

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MRC Article - Identifiability, anonymisation and pseudonymisation

22nd March 2021

MRC - Identifiability, anonymisation and pseudonymisation article on Guidance note 5.

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RSI in Clinical Trials: MHRA Findings and Tips

22nd March 2021

RSI in Clinical Trials: MHRA Findings and Tips - from Safety Observer

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What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?

22nd March 2021

An interesting article written by Harry Mingay and Dr. Rita Hendricusdottir on the classification of IVD devices taken from Oxford Global Guidance.

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eClinical Forum - eCF Requirements PR2020

22nd March 2021

ABOUT 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.

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EMA - Veterinary Big Data Stakeholder Forum

10th March 2021

EMA is pleased to announce a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1-2 June 2021.

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MHRA - Pharmacovigilance inspection metrics April 2019 to March 2020

3rd March 2021

MHRA have published Pharmacovigilance inspection metrics April 2019 to March 2020.

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