COURSE OUTLINE : The course is developed by Clinical Development Services Agency (CDSA) in partnership with the Central Drugs Standard Control Organisation (CDSCO). The course is developed with NPTEL. Learn Overview of Indian regulatory system. Overview of Drugs & Cosmetics Act and Rules thereunder. Overview of New Drugs and Clinical Trials Rules, 2019. PRE-CLINICAL DATA REQUIREMENTS. RULES GOVERNING CLINICAL TRIALS. Phases of Clinical Trial, Forms, and Fees. Regulatory pathway and data requirements for NDCT, 2019. BA/BE study and study Centers: Legal provisions.
ABOUT INSTRUCTOR : Prof. Braj Bhushan is a professor of psychology at IIT Kanpur. His research interest lies in Cognitive Neuropsychology, Cognitive Factors in esign, Trauma Psychology. He has been awarded with many laurels some being “Our Common Future Fellowship (2010), Volkswagen Stiftung, Germany”, “Abstract Award (2008), International Association for Suicide Prevention, 3rd Asia Pacific Regional Conference of IASP, Hong Kong”, “In Search of Excellence’ Award (2004), IAAP and NAOP-I”, “Young Scientist Award (2002), Indian Science Congress Association”, “B.H.U. Merit and Prize Award (1991), Banaras Hindu University”
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