198 results
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Guidance for medicine developers and other stakeholders on COVID-19
Last updated: 27/11/2020 -
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GMP/GDP Inspectors Working Group
Last updated: 23/11/2020 -
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Multidisciplinary: vaccines
Last updated: 19/11/2020 -
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Paediatric investigation plans: questions and answers
Last updated: 13/11/2020 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 11/11/2020 -
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Scientific advice
Last updated: 09/11/2020 -
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Compassionate use
Last updated: 26/10/2020 -
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Requesting scientific advice or protocol assistance from EMA
Last updated: 19/10/2020 -
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Qualification of novel methodologies for medicine development
Last updated: 19/10/2020 -
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Submitting annual reports on medicine development
Last updated: 02/10/2020 -
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Orphans: Regulatory and procedural guidance and forms
Last updated: 28/09/2020 -
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Parallel consultation with regulators and health technology assessment bodies
Last updated: 17/09/2020 -
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Good clinical practice (GCP) inspection procedures
Last updated: 10/06/2020 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020 -
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European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting
Virtual meeting, 02/06/2020, Last updated: 05/06/2020 -
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Innovation in medicines
Last updated: 18/05/2020 -
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EudraVigilance: electronic reporting
Last updated: 23/04/2020 -
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Submission deadlines for orphan designations
Last updated: 20/04/2020 -
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Paediatric investigation plans: Templates, forms and submission dates
Last updated: 14/04/2020 -
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EudraVigilance: how to register
Last updated: 27/03/2020 -
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Biostatistics
Last updated: 25/03/2020 -
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Rewards and incentives for paediatric medicines
Last updated: 11/02/2020 -
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Quality of medicines questions and answers: Part 1
Last updated: 05/02/2020 -
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Advice on impacts of using antimicrobials in animals
Last updated: 28/01/2020 -
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Applying for orphan designation
Last updated: 16/01/2020