Transcription of PDCO EMA Update AMK 13-06-2017
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PDCO EMA Update AMK 13-06-2017
PDCO / EMA updateChallenges and opportunities in paediatric developmentAnn Marie Kaukonen, Researcher, Pharmaceutical AssessorPDCO member, PDCO FWG memberJoint NORDICPedMed / PIF Nordic Conference on Pediatric Medicines 13th June, Helsinki, Finland L kealan turvallisuus- ja kehitt miskeskus The views expressed in this presentation are the personal views of the presenter and may not be understood or quoted as being made on behalf of or reflecting the position of the Finnish Medicines Agency, the European Medicines Agency or any of its committees or working Paed Conference - AMK2 DisclaimerL kealan turvallisuus- ja kehitt miskeskusStructure Background - Paediatric Regulation and PIPs Dialogue with PDCO/EMA Global interaction EMA / FDA Enpr-EMA2017-06-13 Nordic Paed Conference - AMK3L kealan turvallisuus- ja kehitt miskeskus2017-06-13 Nordic Paed Conference - AMK4 Background Regulation (EC) No 1901/2006 2007: entry into force 2017: EC to present report to EP (Article 50 (3)) EMA report on the objectives of the regulation:1.
Lääkealan turvallisuus- ja kehittämiskeskus Structure • Background - Paediatric Regulation and PIPs • Dialogue with PDCO/EMA • Global interaction EMA / FDA
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