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EC - Good Lay Summary Practice
7th December 2021The European Commission (EC) has published a guideline on Good Lay Summary Practice"(GLSP). The guideline was adopted by the Clinical Trials Expert Group (CTEG) of the EU Commission, which is composed of representatives of ethics committees and national competent authorities.
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
7th December 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
MHRA - UK PSMF
7th December 2021Additional guidance on requesting a UK PSMF number was added on 30th November 2021.
EMA - Publication of Article on Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
26th November 2021EMA - Publication of Article on Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
11th November 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
11th November 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
EMA - Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021
11th November 2021Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021
EMA - Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia
11th November 2021Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia
MHRA - GLPMA Stakeholder Meeting Minutes May 2021
11th November 2021The UK GLPMA hold periodic meetings with stakeholders. The minutes of the last meeting can be found here UK GLPMA Consultative committee meeting minutes May 2021
MHRA - Medicines: licensing time-based performance measures
11th November 2021Medicines: licensing time-based performance measures
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