UNIT I New Drug Discovery and development Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development. (Chapter - 1) UNIT II Regulatory Approval Process Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA. Regulatory authorities and agencies Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications). (Chapter - 2) UNIT III Registration of Indian drug product in overseas market Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD) research. (Chapter - 3) UNIT IV Clinical trials Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors and Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials. (Chapter - 4) UNIT V Regulatory Concepts Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book. (Chapter - 5)
