BP804 ET PHARMACEUTICAL REGULATORY SCIENCE
Monitoring, detecting, and preventing adverse drug reactions, ensuring safe and effective use of medications through:
– Adverse event reporting and analysis
– Risk management and mitigation
– Regulatory compliance and safety surveillance”
Course Content
Unit Title
Content
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.
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)
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.
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 & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance- safety monitoring in clinical trials
UNIT-V
- Regulatory Concept
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
Learning Objectives
- Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
- ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
- CIOMS requirements for ADR reporting
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