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Addressing specific regulatory excipientrequirements in the marketing authorizationAddressing specific regulatory excipientrequirements in the marketing authorizationDr. Philipp HebestreitGlobal regulatory AffairsPharma Ingredients & ServicesBASF SEPharmSciFair Nice, June 11th, 2009Dr. Philipp Hebestreit, Pharma Ingredients & Services, BASF SEPresentation PharmSciFair of excipient vs. API registrationzClassification of excipientszExcipient guidancezRegistration challenges of well-known vs. new excipientszThe basis for successful registration: excipient master fileszSafety assessment of excipientszHot topicszIndustry concernszCase study: Registration of a novel excipientzSummary & conclusionDr. Philipp Hebestreit, Pharma Ingredients & Services, BASF SEPresentation PharmSciFair , Manufacturing and ControlsEMEA/ EMA -European Medicines (Evaluation) AgencyAPI-Active Pharmaceutical IngredientFDA-Food and Drug AdministrationCDER-Center for Drug Evaluation and ResearchIIG/ IID-Inactive Ingredient Guide/ -DatabaseDMF/ EMF -Drug Master File/ excipient Master FilePh.
Addressing specific regulatory excipient requirements in the marketing authorization Dr. Philipp Hebestreit Global Regulatory Affairs Pharma Ingredients & Services
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