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Program Coverage


The Program would cover the following areas:


        Drug discovery process (including stages of basic research, drug development which involves pre-clinical testing, clinical research, registration with the drug regulatory agencies, and finally introduction of the drug to the public after approvals, etc.)

        Good Clinical Practices and Ethics in Clinical Research

         Brief discussion on pre-clinical trials (In-silico & In-vivo trials)

        Phases of Clinical Research (Phase I – IV)

         Protocol designing, development and amendments

        Roles of Investigators, Hospitals and Health Institutions, sponsors in a clinical trial.

        Role of Independent Ethics Committee/ Institutional Review Board

        Preparation of Trial reports (Medical writing) and regulatory dossier

        Pharmacovigilance & Clinical safety

        Overall management of a clinical trial including fundamentals of monitoring of trials

        Regulatory Affairs

        Quality Assurance and Quality auditing practices

        Good laboratory Practices and Good Documentation Practices

        Good Clinical laboratory Practices

        Basics of Biostatistics

        Clinical Data Management (CDM)

All these would form part of the curricula and will be covered in intensive Theory, Practicals, Industrial visits, Onsite training and Internship sessions as per detailed Syllabus.