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.