62 results
Topic
SME Remove SME filter
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Withdrawn application: Somnena
buprenorphine, date of withdrawal: 29/01/2016, Initial authorisation, Last updated: 14/09/2017 -
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Withdrawn application: Oxapex
date of withdrawal: 13/03/2012, Initial authorisation, Last updated: 25/06/2012 -
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Withdrawn application: Paccal Vet
paclitaxel, date of withdrawal: 02/03/2012, Initial authorisation, Last updated: 25/04/2012 -
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Newsletters (updated)
Last updated: 30/05/2023 -
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EIC / EMA Info Day: Regulatory support for the development of innovative medicines and technologies
Online, 09:00 - 12:30 Amsterdam time (CET), 31/01/2023, Last updated: 23/03/2023 -
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Regulatory and scientific virtual conference on RNA-based medicines
Online, 09:00 - 16:30 Amsterdam time (CET), 02/02/2023, Last updated: 24/02/2023 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
Last updated: 01/02/2023 -
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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
Online, 28/10/2021, Last updated: 04/01/2022 -
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Applying for SME status
Last updated: 07/12/2021 -
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Support to SMEs
Last updated: 07/12/2021 -
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SME Regulation and reports
Last updated: 07/12/2021 -
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Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
Online, 09:00-13:30 Amsterdam time (CET), 29/11/2021, Last updated: 25/11/2021 -
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SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 1
Virtual event, 22/02/2021, Last updated: 30/06/2021 -
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SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2
Virtual event, 04/03/2021, Last updated: 26/05/2021 -
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EMA roundtable with stakeholders on the 15-year anniversary of the SME Regulation
Virtual meeting, 27/11/2020, Last updated: 15/12/2020 -
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Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
Virtual meeting, 11/12/2020, Last updated: 11/12/2020 -
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Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers
European Medicines Agency, London, UK, 26/10/2018, Last updated: 21/02/2019 -
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Info day for micro, small and medium-sized enterprises: supporting innovative medicines' development and early access
European Medicines Agency, London, UK, 17/11/2017, Last updated: 13/02/2018 -
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News: New action plan to support SMEs as drivers of pharmaceutical innovation
Last updated: 31/05/2017 -
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SME info day on the new clinical trial regulation
European Medicines Agency, London, UK, 20/03/2017, Last updated: 30/03/2017 -
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Workshop for micro-, small- and medium-sized enterprises: statistical perspectives in regulatory clinical development programmes
European Medicines Agency, London, UK, 05/02/2016, Last updated: 14/11/2016 -
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News: Regulatory information – Updated SME user guide now available
Last updated: 19/10/2016 -
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Supporting SMEs
Last updated: 21/07/2016 -
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Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects
European Medicines Agency, London, UK, 03/10/2016, Last updated: 19/05/2016 -
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News: Supporting innovative SMEs as major drivers of new pharmaceutical developments
Last updated: 11/05/2016