Definition of a Drug Columbia University一个药物的定义哥伦比亚大学.pptVIP

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Definition of a Drug Columbia University一个药物的定义哥伦比亚大学.ppt

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BIOPHARMACEUTICAL DEVELOPMENT REGULATION Ron Guido Alan McEmber Course Details Fall 2007: W4200 Section 001 : BIOPHARMACEUTICAL DEVELOPMENT REGULATION Meets: Thursday 2:40pm-4:40pm Location: 1000 Sherman Fairchild Life Sciences Building Instructors: Ron Guido, Alan McEmber Instructor Contact : ron.guido@; alan.mcember@ Course Details Class Modules (Subject to Change) History of Regulation (incl. Regulatory Defined, Major Regulatory Bodies Worldwide) Basics of Drug Discovery and Development Pharmacokinetics / Pharmacodynamics (from a Regulatory viewpoint) Non Clinical Pharm/ Tox (incl. cGMP) Standards of Approval (Rx, OTC, Biologics, Biotech) IND / CTD / CTx (inc. cGCP) NDA / MAA (US, EU, Japan, National Deep Dive US Regulatory Deep Dive EU Regulatory Clinical Program Development / Labeling Development and Revision Post Approval Actions (Studies, Amendments, Supplements, Variations) EU / US cGMP and Inspection CMC and Change Control Recalls and Field Actions – Product Queries OTC / Consumer Products Advertising and Promotion Agency Meetings and Communication Introduction to Regulatory Assessment and Strategy Course Details Method of Assessment: 3 Take Home (24-Hour) Assessments, 10 short responses per assessment. May require light research and problem solving Textbook: Drug Discovery and Development: Technology in Transition, H.P. Rang, Churchill Livingstone (Elsevier) 2006 NOTE: Supplemental readings will be posted Drug Development Terminology and Basic Concepts ..from the Regulatory Perspective.. For your consideration Drug /Biotech Development requires cutting edge science, but that’s not all its about Regulation is supported by science, but science and regulation often part company Industry, clinical excellence groups lead regulation Novelty lowers hurdles for approval, but often complicates review process Product is defined by its active, and the associated claims of action Product needs to have a meaningful clinical effect Burden of proof is on the s