Pharmaceutical Regulatory Science

Teacher

Dr. BIKASH RANJAN JENA, M.Pharm., Ph.D

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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

 

Non clinical activities and non clinical studies

https://www.youtube.com/watch?v=Oyy7zR1i2nc

Session 3:

Clinical studies and concept of Generics and innovator in drug development

 

CONCEPT OF GENERICS, GENERIC DRUG PRODUCT DEVELOPMENT

Session 4:

Non-clinical activities, Non-clinical studies in drug development

 

Non clinical activities and non clinical studies

Session 5:

Approval processes and timelines involved in Investigational New Drug (IND)

Investigational New Drug Application

Session 7:

Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Applications

Session 8:

Changes approved to a NDA and ANDA in Regulatory Approval process.

Changes to an-Approved NDA and ANDA

NDA and ANDA in regulatory approval process

Session 9:

Regulatory authorities and agencies. Overview of regulatory authorities of India,

Drug Regulatory Authority 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

international drug regulatory authority (Canada,USA)

Session 12:

Registration of Indian drug product in overseas market, Technical documentation

Drug registration in market

Session 13:

Registration of Indian drug product in overseas market : Procedure for export of pharmaceutical products

Registration of drug product in market strategies

Session 14:

Drug Master Files (DMF) and its submission process

Drug master file (DMF)

Session 15:

salient features and types of DMF, LOA to FDA

Types of DMF and its salient feature

Session 16:

salient features and types of DMF

 LOA to FDA

Types of DMF and its salient feature

Session 17:

Common technical Document (CTD), Origin and Overview

Common Technical Document (CTD) Overview

Session 18:

salient features and types of DMF

LOA to FDA

Types of DMF and its salient feature

Session 19:

Common Technical Document (CTD)

Common Technical Document (CTD) Overview

Session 20:

Common Technical Document (CTD), structure, significance, concept of eCTD

CTD structure, modules, siginificance and eCTD

Session 21:

electronic Common Technical Document (CTD), salient features

eCTD, salient features,Regulatory Submission

Session 22:

Common Technical Document (CTD), eCTD, basic principles and the regulatory submission process

CTD structure, modules, siginificance and eCTD

https://www.youtube.com/watch?v=iRpqD92Spc4

Session 23:

ASEAN Common Technical Document (ACTD)research.

ACTD (ASEAN Research and its submision guidelines)

Session 24:

ASEAN Common Technical Document (ACTD) research guidelines for generic product development

ASEAN (ACTD Guidelines for generic products)

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 29:

Informed consent process and procedures

Informed consent process and procedures

Session 30:

GCP obligations of Investigators, sponsors & Monitors

GCP obligartions, Investigators, Sponsors

Session 31:

Monitors, Managing and Monitoring clinical trials

Monitoring clinical trails

Session 32:

Monitoring clinical trial and clinical trail management system

clinical-trial-management-systems- Management and monitoring

Session 33:

Pharmacovigilance - significance  in clinical trials

Pharmacovigilance, siginificance monitoring

Session 34:

Drug Safety evaluation in clinical trail

Pharmacovigilance - safety monitoring in clinical trials

Session 35:

Basic terminology, guidance, guidelines, regulations

https://www.youtube.com/watch?v=CP3wzIzrDAA

Session 36:

Laws and Acts of Regulatory science as per USFDA concerned

https://www.youtube.com/watch?v=8Q_Um-v9j_o

https://www.youtube.com/watch?v=CjeG--ik_bw

Session 38:

Applications and advantages of the Orange book

Applications of Orange Book- 

Session 39:

Concept and significance of Federal Register

Code of Federal Regulations

 

Session 40:

Code of Federal Regulatory, (21 CFR , part 11)

21 Code of Federal regulations (21 CFR)

Session 41:

Code of Federal Regulatory, (21 CFR , part 11)

21 Code of Federal regulations (21 CFR)

Session 42:

The concept of Purple book and its advantages in Biological Products

The concept and siginificance of Purple book

Our Main Teachers

Dr. BIKASH RANJAN JENA, M.Pharm., Ph.D

Associate Professor, M.Pharm., Ph.D.
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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), […]