Anna University                  Apollo Hospitals Educational &             Auroville HealthCare

AU-KBC Research Centre      Research Foundation (AHERF)                    R & D Private Limited (AHC)

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 the due Approvals, etc.)

The list of course modules are :

Module 1:    Introduction to Drug Discovery and Development

Module 2:    Types of Clinical Research and Phases in Clinical Trial

Module 3:    Good Clinical Practices

Module 4:    Ethics in Clinical Research

Module 5:    Pre Clinical Research

Module 6:    National and International Regulations in Clinical Research

Module 7:    Regulatory Affairs in Clinical Research

Module  8:   Planning, Designing and Documentation in Clinical Trial

Module  9:   Management of Clinical Trial

Module  10: Quality Assurance and Quality Control in Clinical Trial

Module  11: Clinical Data Management and Biostatistics

Module  12: Safety Reporting and Pharmacovigilance

All the above listed modules are part of the curricula and elaborated in study materials. The study materials will be provided to the students, which have to be read during distance learning periods. The modules will also be discussed with faculties during contact sessions with practical examples. Practical and Onsite training will be arranged during Observership days.