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News Archive
MHRA - Good Distribution Practice Symposium 2023
2nd May 2023Held on 21-22 February 2023 - here is write up of the event.
EMA - CHMP Highlights 24 - 26 April 2023
27th April 2023Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
EMA - CVMP Meeting Highlights 18-20 April 2023
26th April 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
EMA - CTIS newsflash – 21 April 2023
26th April 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Clinical Trials Highlights 14
26th April 2023April 2023 issue of Clinical Trials Highlights.
EMA - Human Medicines Highlights Newsletter 168
26th April 2023Key information for patients, consumers and healthcare professionals.
EMA - PRAC 11-14 April 2023
26th April 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines
26th April 2023On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.
EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
26th April 2023EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).
FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
26th April 2023This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.
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