Pharmaceutical Regulatory Science
Teacher
Dr. BIKASH RANJAN JENA, M.Pharm., Ph.D
Category
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Course Name : PHARMACEUTICAL REGULATORY SCIENCE
Code(Credit) : BPHT4204(4-0-0)
Course Type: Core
Course Objective
After completion of course student is able to know,
various drug regulations, regulatory bodies like WHO, USFDA
The analysis of various drugs in single and combination dosage forms
Theoretical and practical knowledge of the drug relations
Course Outcome:
| CO | Statement | Mapping with POs |
| CO-1 | To get knowledge about the process of drug discovery and development | PO1, PO2, PO6 |
| CO-2 | Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals | PO1, PO6, PO8 |
| CO-3 | Know the regulatory approval process and their registration in Indian and international markets | PO1, PO8, PO9 |
| CO-4 | To understand the drug approval process using new drug applications (NDA) and (ANDA) applications | PO1, PO3, PO8 |
| CO-5 | To know about various regulatory concepts and terminology including code of federal regulatory (CFR) etc. | PO1, PO6, PO8 |
Course Syllabus
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 anapproved 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 Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
References:
1.Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. 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.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / SandyWeinberg. By John Wiley &
Sons. Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and
biologics /edited by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
Isader Kaufer, Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
By Fay A. Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I.
Gallin and Frederick P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng
Session Plan
Session 1 : Stages of drug discovery, Drug development process, pre-clinical studies
Session 2
Non-clinical activities, Non-clinical studies in drug development
Session 3:
Clinical studies and concept of Generics and innovator in drug development
Session 4:
Non-clinical activities, Non-clinical studies in drug development
Session 5:
Approval processes and timelines involved in Investigational New Drug (IND)
Session 6:
New Drug Application (NDA)
Session 8:
Changes approved to a NDA and ANDA in Regulatory Approval process.
Session 9:
Regulatory authorities and agencies. Overview of regulatory authorities of India,
Session 10:
International Regulatory authorities and agencies United States, European Union, Australia
International Regulatory Authorities of Various Countries-converted
Session 11:
International Regulatory authorities and agencies of Canada
Session 12:
Registration of Indian drug product in overseas market, Technical documentation
Session 13:
| Registration of Indian drug product in overseas market : Procedure for export of pharmaceutical products |
Session 17:
Common technical Document (CTD), Origin and Overview
Session 20:
Common Technical Document (CTD), structure, significance, concept of eCTD
Session 21:
electronic Common Technical Document (CTD), salient features
Session 22:
Common Technical Document (CTD), eCTD, basic principles and the regulatory submission process
Session 23:
| ASEAN Common Technical Document (ACTD)research. |
Session 24:
| ASEAN Common Technical Document (ACTD) research guidelines for generic product development |
Session 25:
| Overview of clinical Trails and its siginificance (Introduction) |
Session 26:
Clinical trail drug development, contents and protocol development, Schedule Y, Trial Registry
Clinical Trail Registry, Protocol, and drug development, ICH E6guidelines
Session 27:
Purpose and principles of consent, Elements of informed consent, Document of Informed Consent form
Principle, Purpose, and Documentation of Informed consent form
Session 28:
Independent Ethics committee - formation and working procedures
Institutional and independent ethics committee, working procedures
Session 28:
Independent Ethics committee - formation and working procedures
Institutional and independent ethics committee, working procedures
Session 30:
GCP obligations of Investigators, sponsors & Monitors
Session 32:
Monitoring clinical trial and clinical trail management system
clinical-trial-management-systems- Management and monitoring
Session 33:
Pharmacovigilance - significance in clinical trials
Session 34:
Drug Safety evaluation in clinical trail
Session 35:
Basic terminology, guidance, guidelines, regulations
Session 36:
Laws and Acts of Regulatory science as per USFDA concerned
Session 42:
The concept of Purple book and its advantages in Biological Products
Our Main Teachers
About Me My self Dr.Bikash Ranjan Jena currently working in Pharmaceutical Analysis & Research Division, School of Pharmacy and Life Sciences (SoPLS), Centurion University, Bhubaneswar since Jan 2021. I have successfully awarded my Ph.D degree at KLEF Deemed to be University, Vaddeswaram, Guntur, A.P on 22nd June 2023. Expertised in Analytical Quality by Design (AQbD), […]