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.
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)
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.
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
Regulatory Concepts: Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
‘Pharmaceutical Regulatory Science – Theory’ is a course offered in the eighth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.
Scope & Objectives
Duration: 45 Hours
This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn in detail on the regulatory requirements, docu- mentation requirements, and registration procedures for marketing the drug products.
Upon completion of the subject student shall be able to;
- Know about the process of drug discovery and development
- Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
- Know the regulatory approval process and their registration in Indian and international markets
Recommended Books (Latest Editions)
- Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
- The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.
- New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edi- tion, Drugs and the Pharmaceutical Sciences,Vol.190.
- Guidebook for drug regulatory submissions / SandyWeinberg. By John Wiley & Sons. Inc.
- FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus.
- Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Mar- cel Dekker series, Vol.143
- Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Ro- zovsky and Rodney K. Adams
- Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
- Drugs: From Discovery to Approval, Second Edition By Rick Ng