Unit I (10 Hours)
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.
Unit II (10 Hours)
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, Europe- an Union, Australia, Japan, Canada (Organization structure and types of applications)
Unit III (10 Hours)
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 Com- mon Technical Document (ACTD)research.
Unit IV (08 Hours)
Clinical trials: Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - forma- tion and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safetymonitoring in clinical trials
Unit V (07 Hours)
Regulatory Concepts: Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book