211 results
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ICH: quality
Last updated: 01/04/2022 -
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Union Product Database: follow up webinar for marketing authorisation holders
Online, 15:00 - 16:30 Amsterdam time (CET), 25/01/2022, Last updated: 22/03/2022 -
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Seventh industry stakeholder platform on research and development support
Online, 23/11/2021, Last updated: 17/03/2022 -
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Q&A: Good clinical practice (GCP)
Last updated: 15/03/2022 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 16/02/2022 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022 -
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Regulatory science research needs launch event
Online, 10:00 - 12:00 Amsterdam time (CET), 18/01/2022, Last updated: 04/02/2022 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers
Last updated: 04/02/2022 -
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Change management for the EudraVigilance system
Last updated: 03/02/2022 -
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Clinical Trials Regulation
Last updated: 31/01/2022 -
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Novel therapies
Last updated: 28/01/2022 -
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ICH guideline Q13 on continuous manufacturing of drug substances and drug products
Last updated: 27/01/2022 -
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Union Pharmacovigilance Database: follow up webinar on signal detection, evaluation and yearly reporting
Online, 19/01/2022, Last updated: 26/01/2022 -
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EudraVigilance training and support
Last updated: 06/01/2022 -
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Classifications as minor-use-minor-species and limited-market according to former EMA policy
Last updated: 06/12/2021 -
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EudraGMDP database
Last updated: 01/12/2021 -
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CHMP opinions on consultation procedures
Last updated: 18/10/2021 -
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Paediatric investigation plans: questions and answers
Last updated: 11/10/2021 -
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Plasma Master File (PMF) submissions
Last updated: 08/10/2021 -
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Guidance for medicine developers and other stakeholders on COVID-19
Last updated: 30/09/2021 -
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Sixth industry stakeholder platform on research and development support
Online, 04/06/2021, Last updated: 23/09/2021 -
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Safety and residues: pharmaceuticals
Last updated: 25/06/2021 -
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Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need
Last updated: 22/04/2021 -
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European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021
Virtual meeting, 25/03/2021, Last updated: 14/04/2021 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
Last updated: 29/03/2021