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News Archive
FDA - FDA Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical GMP
19th January 2023FDA have signed an Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice.
MHRA - Horizon Scanning Case Study
19th January 2023MHRA - Horizon Scanning Case Study
MHRA - MHRA increases UK assessment capacity for in-vitro diagnostic devices
19th January 2023MHRA increases UK assessment capacity for in-vitro diagnostic devices
MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group
19th January 2023MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group
EMA: Facilitating Decentralised Clinical Trials in the EU
11th January 2023The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
EMA: Virtual Public CTIS Event
11th January 2023The EMA are holding a virtual public CTIS event “CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023”.
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
21st December 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022
21st December 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
21st December 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
EMA - Recommendation Paper on Decentralised Elements in Clinical Trials
21st December 2022The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
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