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.