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.
For the forthcoming conference, we will be continuing with debates as well as adhering to the format of the previous conferences which are designed to provide an in-depth progress report on new antiepileptic drugs in various stages of development, as well as to present new findings on second-generation treatments.
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