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Press release: Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects
PRAC, Last updated: 05/10/2018 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018
PRAC, Last updated: 05/10/2018 -
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News: Shaping regulatory science to 2025
Last updated: 17/10/2018 -
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News: Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications
Last updated: 20/11/2018 -
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News: Workshop: advancing regulatory science to 2025 for veterinary medicines
Last updated: 29/11/2018 -
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News: Data from patient registries to replace clinical trials in previously untreated haemophilia patients
Last updated: 30/11/2018 -
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News: Revised guideline to assess risk of human medicines for the environment
Last updated: 30/11/2018 -
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Press release: Regulatory Science to 2025 – launch of six-month public consultation
Last updated: 19/12/2018 -
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News: The role of regulators in establishing added benefit of novel therapies
Last updated: 11/04/2019 -
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News: COVID-19: developers of medicines or vaccines to benefit from free scientific advice
Last updated: 13/03/2020 -
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News: First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
Last updated: 18/03/2020 -
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Press release: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
Last updated: 20/03/2020 -
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Press release: Advancing regulatory science in the EU – new strategy adopted
Last updated: 31/03/2020 -
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News: COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
Last updated: 01/04/2020 -
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News: International regulators discuss available knowledge supporting COVID-19 medicine development
Last updated: 03/04/2020 -
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News: Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data
Last updated: 16/04/2020 -
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Press release: COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
Last updated: 04/05/2020 -
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Press release: Global regulators commit to cooperate on observational research in the context of COVID-19
Last updated: 20/05/2020 -
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Press release: EMA calls for high-quality observational research in context of COVID-19
Last updated: 26/05/2020 -
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Press release: EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines
Last updated: 27/05/2020 -
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Press release: Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic
Last updated: 09/06/2020 -
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News: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
Last updated: 21/07/2020 -
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News: Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
Last updated: 31/07/2020 -
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News: Global regulatory workshop on COVID-19 real-world evidence and observational studies
Last updated: 31/07/2020 -
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News: Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
Last updated: 14/09/2020