Home Index

AU-KBC RESEARCH CENTRE

Program Coverage

 

The Training Program would cover the following areas:

 

        Drug discovery process includes stage of basic research, stage of drug development which involves pre-clinical testing, clinical research, and registration with the drug regulatory agency such as FDA and finally introduction of the drug to the public after approval.

        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 – III)

        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

        Basics of Biostatistics

        Clinical Data Management (CDM)

 

All these would form part of the curricula and will be covered in intensive Theory, Practicals and Project/Internship sessions as per a detailed Syllabus.

[Back]