1332 results
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Clinical Trials Regulation (updated)
Last updated: 20/01/2022 -
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Union Pharmacovigilance Database: webinar on signal detection and analysis (updated)
Online, 10:00-13:00 Amsterdam time (CET), from 23/11/2021 to 24/11/2021, Last updated: 20/01/2022 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
Last updated: 20/01/2022 -
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Variations requiring assessment (veterinary medicines) (updated)
Last updated: 20/01/2022 -
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Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012 (updated)
Last updated: 20/01/2022 -
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Variations for veterinary medicines (updated)
Last updated: 20/01/2022 -
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Variations not already listed (veterinary medicines) (updated)
Last updated: 20/01/2022 -
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Variations: guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) (updated)
Last updated: 20/01/2022 -
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Variations not requiring assessment (veterinary medicines) (updated)
Last updated: 20/01/2022 -
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Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms (updated)
Online, 10:30 - 12:00 Amsterdam time (CET), 18/01/2022, Last updated: 12/01/2022 -
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Union Pharmacovigilance Database: follow up webinar on collection and recording of suspected adverse events for veterinary medicinal products (updated)
Online, 10:00-13:00 Amsterdam time (CET), 18/01/2022, Last updated: 07/01/2022 -
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Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (updated)
Last updated: 07/01/2022 -
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EudraVigilance training and support (updated)
Last updated: 06/01/2022 -
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EudraVigilance access policy for medicines for veterinary use (updated)
Last updated: 04/01/2022 -
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Info day for micro, small and medium-sized enterprises (SMEs): EMA support for SMEs under the new Veterinary Medicinal Products Regulation (updated)
Online, 28/10/2021, Last updated: 04/01/2022 -
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Pre-authorisation guidance (updated)
Last updated: 22/12/2021 -
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PRIME: priority medicines
Last updated: 21/12/2021 -
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Mock-ups for veterinary medicines
Last updated: 20/12/2021 -
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Advanced therapy classification
Last updated: 20/12/2021 -
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Summary of product characteristics for antiparasitic veterinary medicinal products
Last updated: 16/12/2021 -
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Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 16/12/2021 -
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Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 16/12/2021 -
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Guideline on the acceptability of names for human medicinal products processed through the centralised procedure
Last updated: 16/12/2021 -
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ICH Q9 Quality risk management
Last updated: 16/12/2021 -
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Last updated: 15/12/2021