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Press release: New Paediatric Committee holds its first meeting
PDCO, Last updated: 06/07/2007medicinal products, such as pharmaceutical development, paediatric medicine … general practice, paediatric pharmacy, paediatric pharmacology, paediatric research pharmacovigilance, ethics and public health … medicinal products, such as pharmaceutical development, paediatric medicine … -
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Paediatric rheumatology expert group meeting
London, UK, 04/12/2009, Last updated: 28/05/2010development, clinical use and pharmacovigilance of medicines for juvenile … 28/05/2010 Generic Long-term PHARMacovigilance for Adverse effects in Childhood … 28/05/2010 Generic Paediatric Pharmacovigilance, Dr Dirk Mentzer PDF icon … -
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News: Committee for paediatric medicinal products - towards more and better information on the use of medicines for children
PDCO, Last updated: 18/02/2013European Union (EU) in 2007, pharmaceutical companies have had a legal … already authorised in the EU. Pharmaceutical companies that develop a … medicines, and to agree with the pharmaceutical companies on the clinical … -
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News: Call for expressions of interest to appoint patient and healthcare-professional representatives as members of Paediatric Committee
PDCO, Last updated: 24/09/2013practitioners, clinicians, pharmacists or other healthcare professionals … representatives. Similarly, the Agency's Pharmacovigilance Risk Assessment Committee … foreseen by the European pharmacovigilance legislation and the European … -
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News: European Medicines Agency hosts workshop on ethics in paediatric clinical trials
PDCO, Last updated: 02/12/2011representatives from more than 40 pharmaceutical companies and experts in … paediatric clinical researchers, pharmaceutical companies, the Agency, the … -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021co-developed by Regeneron Pharmaceuticals Inc. and Roche Registration … EMA’s safety committee ( Pharmacovigilance Risk Assessment Committee … information can be found under 'Pharmacovigilance Risk Assessment Committee … -
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News: European Medicines Agency publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans
PDCO, Last updated: 31/07/2014force in the EU in 2007, pharmaceutical companies have had a legal … on the clinical studies, pharmaceutical forms and tests that must … Definitions: Applicant The pharmaceutical company or person proposing … -
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News: EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 18/11/2021EMA’s safety committee ( Pharmacovigilance Risk Assessment Committee … information can be found under 'Pharmacovigilance Risk Assessment Committee … -
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News: Meeting highlights from the Paediatric Committee: 09 -11 December 2009
PDCO, Last updated: 17/12/2009BIM 23A760), from Ipsen Pharma, in the therapeutic area of … BIM 23A760), from Ipsen Pharma, in the therapeutic area of … -
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Second paediatric strategy forum on medicine development for mature B cell malignancies in children
European Medicines Agency, London, UK, from 13/11/2017 to 14/11/2017, Last updated: 29/06/2017academia Representatives of pharmaceutical industry Representatives … representatives, clinicians, academics, pharmaceutical companies, and regulators … Review of products by the pharmaceutical industries 17:00 – 17:30 … -
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News: Paediatric Committee elects new Chair and Vice-Chair
PDCO, Last updated: 13/09/2013is currently Head of the Pharmacovigilance Unit at the Paul-Ehrlich … -
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News: Expressions of interest invited for workshop on ethics of clinical trials in children
PDCO, Last updated: 26/07/2011paediatric research networks, the pharmaceutical industry or contract research … -
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News: Public consultation opens on standard paediatric investigation plans for two types of cancer in children
PDCO, Last updated: 22/02/2013standard PIPs is to support pharmaceutical companies to propose a plan … http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc mailto:paediatrics@ema.europa.eu pharmaceutical companies to propose a PIP … -
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News: Report and videos available from Enpr-EMA launch
PDCO, Last updated: 27/05/2011clinical researchers and pharmaceutical industry staff responsible … clinical researchers, and pharmaceutical industry staff responsible … co-opted member for Paediatric Pharmacovigilance in the CHMP Pharmacovigilance Working Party at the EMA … -
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News: EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 04/10/2021EMA’s safety committee ( Pharmacovigilance Risk Assessment Committee … information can be found under 'Pharmacovigilance Risk Assessment Committee … -
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News: European Commission report highlights successes of the first five years of the EU Paediatric Regulation
PDCO, Last updated: 24/06/2013terms of child-appropriate pharmaceutical forms. Additionally, the … children, with age-appropriate pharmaceutical forms and composition (formulation … Investigation Plans (PIPs) with pharmaceutical companies, to provide data … -
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News: European Medicines Agency publishes policy on changing scope of paediatric investigation plans
PDCO, Last updated: 27/07/2012a medicine for children. Pharmaceutical companies submit proposals … of administration, or new pharmaceutical form[s] according to article … and the new indications, pharmaceutical forms and routes of administration” … -
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News: EMA recommends approval of Spikevax for children aged 6 to 11
CHMP, PDCO, Last updated: 24/02/2022information can be found under 'Pharmacovigilance - Overview' pharmacovigilance system and ongoing and additional … -
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News: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (new)
CHMP, PDCO, Last updated: 23/06/2022information can be found under 'Pharmacovigilance - Overview' pharmacovigilance system and ongoing and additional … -
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Ethical considerations for paediatric trials - how can ethics committees in the European Member States and the Paediatric Committee at the European Medicines Agency work together?
European Medicines Agency, London, UK, from 29/11/2011 to 30/11/2011, Last updated: 20/11/2012paediatric research networks, pharmaceutical companies or contract research … There were also more than 40 pharmaceutical companies. Other participants … paediatric clinical trialists, and pharmaceutical companies. Table of contents … -
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News: General Court upholds European Medicines Agency decision to refuse paediatric waiver for perflubutane
PDCO, Last updated: 15/12/2011investigation plans (PIPs). Pharmaceutical companies can have this obligation … diagnostic purposes Pharmaceutical form(s): Lyophilisate for … -
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Paediatric Committee (PDCO): 22-25 March 2022 (updated)
Virtual meeting, from 22/03/2022 to 25/03/2022, Last updated: 03/06/2022 -
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Paediatric Committee (PDCO): 17-20 May 2022
Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 18/05/2022 -
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Paediatric Committee (PDCO): 22-25 February 2022
Virtual meeting, from 22/02/2022 to 25/02/2022, Last updated: 06/05/2022 -
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Paediatric Committee (PDCO): 12-15 October 2021
Virtual meeting, from 12/10/2021 to 15/10/2021, Last updated: 11/03/2022