Transcription of Workshop PAEDIATRIC INVESTIGATION PLAN - …
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Workshop PAEDIATRIC INVESTIGATION PLAN - …
Birka LehmannAGAHW orkshopPAEDIATRIC INVESTIGATION PLANHow to Adapt Clinical Development to the Particularities of Paediatrics?13. -14. 01. 2009 BonnMedicinal ProductsNew requirements for marketing authorisation & Information and TransparencyRegulation (EC) No 1901/2006 Regulation 1901/2006 Regulation726/2004 Directive2001/83 SmPC& PLClinical trials in minor&databasePublic databaseMA requirements&InformationGuideline: EthicalConsiderationSmPC GuidelineGuidance:Public informationDirective2001/20 Commission Regulation (EC) No 2049/2005*Scientific Advice(SAWP)Scientific Advice = free off chargeSmall & Medidium SizedEnterprisesCommunication from theCommission The PAEDIATRIC INVESTIGATION plan (PIP)Notice to Applicants EMEA s/PDCO s expectations and experiences with submitted PIPs, Regulatory requirements for PIPs with new drugs, marketed and out-of-patent drugs New PAEDIATRIC
Birka Lehmann AGAH Workshop PAEDIATRIC INVESTIGATION PLAN How to Adapt Clinical Development to the Particularities of Paediatrics? 13. -14. 01. 2009
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