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Protection of personal data and commercially confidential information (CCI) for documents uploaded and published in the Clinical Trials Information System (CTIS): Workshop on draft guidance
Online, 10:00-17:00 Amsterdam time (CEST), 14/07/2022, Last updated: 12/09/2022confidential information (CCI) for documents uploaded and published in … confidential information (CCI) for documents uploaded and published in … confidential information (CCI) in documents submitted or uploaded via … -
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Committee for Medicinal Products for Human Use (CHMP) Biologics Working Party (BWP) stakeholders' meeting on the Guideline on the requirements for quality documentation concerning biological investigational medicinal products (IMP) in clinical trials
European Medicines Agency, London, UK, 16/06/2011, Last updated: 27/05/2011requirements for quality documentation concerning biological investigational … requirements for quality documentation concerning biological investigational … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022medicines for human use. Documents Agenda - PRAC draft agenda … this agenda is a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022medicines for human use. Documents Agenda - PRAC draft agenda … this agenda is a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 March 2017
European Medicines Agency, London, UK, from 20/03/2017 to 23/03/2017, Last updated: 20/03/2017concerning human medicines. Documents CHMP ORGAM agenda for the … this agenda is a working document primarily designed for CHMP … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Paediatric Committee (PDCO): 12-15 October 2021
Virtual meeting, from 12/10/2021 to 15/10/2021, Last updated: 11/03/2022as waivers and deferrals. Documents Agenda - PDCO agenda of the … issued). Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Paediatric Committee (PDCO): 7-10 September 2021
Online, from 07/09/2021 to 10/09/2021, Last updated: 09/09/2021Documents … issued). Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Paediatric Committee (PDCO): 26-29 January 2021
Virtual meeting, from 26/01/2021 to 29/01/2021, Last updated: 11/03/2021Documents … set of minutes is a working document primarily designed for PDCO … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Paediatric Committee (PDCO): 10-13 November 2020
Virtual meeting, from 10/11/2020 to 13/11/2020, Last updated: 25/01/2021as waivers and deferrals. Documents Minutes - PDCO minutes of … set of minutes is a working document primarily designed for PDCO … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Paediatric Committee (PDCO): 8-11 December 2020
Virtual meeting, from 08/12/2020 to 11/12/2020, Last updated: 01/03/2021as waivers and deferrals. Documents Agenda - PDCO agenda of the … issued). Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Paediatric Committee (PDCO): 13-16 October 2020
Virtual meeting, from 13/10/2020 to 16/10/2020, Last updated: 14/12/2020as waivers and deferrals. Documents Agenda - PDCO agenda of the … set of minutes is a working document primarily designed for PDCO … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Paediatric Committee (PDCO): 21-24 March 2017
European Medicines Agency, London, UK, from 21/03/2017 to 24/03/2017, Last updated: 03/07/2014as waivers and deferrals. Documents Minutes - PDCO minutes of … set of minutes is a working document primarily designed for PDCO … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Paediatric Committee (PDCO): 22-24 June 2016
European Medicines Agency, London, UK, from 22/06/2016 to 24/06/2016, Last updated: 04/08/2016as waivers and deferrals. Documents Minutes - PDCO minutes of … set of minutes is a working document primarily designed for PDCO … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Paediatric Committee (PDCO): 25-27 May 2016
European Medicines Agency, London, UK, from 25/05/2016 to 27/05/2016, Last updated: 30/06/2014Documents … -
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Paediatric Committee (PDCO): 21-24 February 2017
European Medicines Agency, London, UK, from 21/02/2017 to 24/02/2017, Last updated: 03/07/2014Documents … issued). Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Paediatric Committee (PDCO): 27-29 January 2016
European Medicines Agency, London, UK, from 27/01/2016 to 29/01/2016, Last updated: 30/06/2014as waivers and deferrals. Documents Minutes - PDCO minutes of … set of minutes is a working document primarily designed for PDCO … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022 (updated)
Online, 14:00 - 15:00 Amsterdam time (CEST), 24/11/2022, Last updated: 25/01/2023via the EMA Service Desk Documents Presentation - Organisation … previously raised • Supporting documentation OMS – Organisation Management … change request Supporting documentation IS required to create/update … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 May 2015
European Medicines Agency, London, UK, from 04/05/2015 to 07/05/2015, Last updated: 13/03/2014Documents … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Committee for Orphan Medicinal Products (COMP): 6-8 December 2022 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/12/2022 to 08/12/2022, Last updated: 01/02/2023treatment of rare diseases. Documents Agenda of the COMP meeting … this agenda is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 (updated)
Online, 10:00 - 13:00 Amsterdam time (CET), 20/01/2023, Last updated: 31/01/2023CTIS event video recordings. Documents Agenda - Clinical Trials … muted https://www.ema.europa.eu/en/about-us/legal/general-privacy-statement https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-organisation-meetings-events_en.pdf Classified … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020medicines for human use. Documents Agenda - PRAC draft agenda … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Committee for Orphan Medicinal Products (COMP): 5-6 February 2013
European Medicines Agency, London, UK, from 05/02/2013 to 06/02/2013, Last updated: 08/05/2012treatment of rare diseases. Documents Minutes of the COMP meeting … meeting Note on access to documents Documents under points 1.1 and 2 to … Agency policy on access to documents (EMA/127362/2006). Contents … -
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Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (updated)
Online, 10:00 - 12:00 Amsterdam time (CEST), 11/11/2022, Last updated: 01/02/2023public health emergencies. Documents Agenda - Executive Steering … 2022 Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (updated)
Online, 09:30 - 11:30 Amsterdam time (CEST), 11/01/2023, Last updated: 01/02/2023public health emergencies. Documents Agenda - Executive Steering … 2022 Note on access to documents Some documents mentioned in the agenda cannot … a request for access to documents within the framework of Regulation … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 30 November-3 December 2015
European Medicines Agency, London, UK, from 30/11/2015 to 03/12/2015, Last updated: 13/03/2014Documents … these minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes …