The course is designed to provide students with a broad and comprehensive understanding of issues related to the development and regulation of drugs, biologics, vaccines, devices, and in vitro diagnostics. Lectures focus on basic drug development topics - such as translational medicine, clinical pharmacology, epidemiology, drug regulation, and adverse drug event reporting - as well as broader - such as pharmacoeconomics, drug-device combinations, biosimilars, working with investigative sites, and drug marketing.
Educational Objectives for CME - at the conclusion of the activity, participants will be able to:
Clinical Pharmacology: Integrate the relevant pharmacology, pharmacokinetics, and statistics related to drug development and the nature of evidence required for proof of efficacy and safety.
Drug Development and Clinical Trials: Using a case-study approach, identify and solve practical, theoretical, and technical problems in human drug studies, and analyze an experimental design for a new drug candidate.
Regulation: Evaluate the science, laws, and regulations pertaining to the development and review of new drug products in the USA, Europe, Japan and other pharmaceutical markets.
*Groups of 3 or more receive discounted rates.
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