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News Archive
FDA - Guidance Snapshots/Podcasts highlight the agency’s commitment to improve the diversity of participants in clinical trials
25th May 2023The FDA have published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials.
WHO - WHO issues urgent call for global climate action to create resilient and sustainable health systems
25th May 2023Today (24th May) at the World Health Organization (WHO), panelists made an impassioned plea for urgent climate action as it hosted a Strategic Roundtable on the Role of the Health Communities in Climate Action: taking stock and moving forward at the World Health Assembly.
ICH - ICH E6(R3) Principles, Annex 1 and Annex 2
23rd May 2023ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.
EMA - Annual report 2022 published
17th May 2023EMA published its annual report 2022 on 15th May 2023. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
EMA - 3-year work plan for the Quality domain
17th May 2023The GMDP IWG 3-year workplan is developed with a focus on the Network Strategy and Regulatory Science Strategy (RSS) goals, with a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain.
EMA - CTIS newsflash – 12 May 2023
17th May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Human Medicines Highlights Newsletter 169
17th May 2023Edition 169
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
17th May 2023Highlights from 10 - 12 May 2023 meeting
EMA - eAF-PMS NEWSLETTER 3
17th May 2023News, views and interviews for the informed stakeholder. Published four times a year by the European Medicines Agency
EMA - recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact
17th May 2023EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.
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