News Archive

OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP

30th August 2022

OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP

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OECD - Position Paper on Quality Improvement Tools and GLP

30th August 2022

OECD - July 2022 Position Paper on Quality Improvement Tools and GLP

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MHRA - Decommission of eSUSAR

5th August 2022

The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products.

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EDQM - Stakeholder consultation – Draft guidelines for medication review

3rd August 2022

Stakeholder Consultation

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EMA - Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making

3rd August 2022

EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).

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EMA - Annual Report 2021

3rd August 2022

EMA release their 2021 Annual Report

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EMA - Big data use for public health: publication of Big Data Steering Group workplan 2022-25

3rd August 2022

The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its PDF icon third workplan that sets key actions to be delivered between 2022–25.

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