REGULATORY AFFAIRS (CUTM1586)

Teacher

Gyanaranjan Parida

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Course Name :

REGULATORY AFFAIRS

(CUTM1586)

 

Code(Credit) : CUTM1586(4-0-0)

Course Objectives

CO Statements Mapping with PO
CO-1 The Concepts of innovator and generic drugs, drug development process PO1,PO3,PO6,PO11
CO-2 The Regulatory guidance’s and guidelines for filing and approval process PO1,PO3,PO6,PO11
CO-3 Preparation of Dossiers and their submission to regulatory agencies in different countries PO1,PO3,PO5, PO8,PO11
CO-4 Post approval regulatory requirements for actives and drug products PO1,PO3,PO5, PO8,PO11
CO-5 Clinical trials requirements for approvals for conducting clinical trials PO1,PO3,PO5, PO9,PO11

Course Outcomes

Course designed to impart advanced knowledge and skills required to learn the
concept of generic drug and their development, various regulatory filings in
different countries, different phases of clinical trials and submitting regulatory
documents : filing process of IND, NDA and ANDA

Course Syllabus

MODULE-I

Documentation in Pharmaceutical industry: Master formula record, DMF (Drug Master File), distribution records. Generic drugs product development Introduction , Hatch- Waxman act and amendments, CFR (CODE OF FEDERAL REGULATION) ,drug product performance, in-vitro, ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in –vivo, scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO.
MODULE-II

Regulatory requirement for product approval: API, biologics, novel, therapies obtaining NDA, ANDA for generic drugs ways and means of US registration for foreign drugs.

MODULE-III

CMC, post approval regulatory affairs. Regulation for combination products and medical devices. CTD and ECTD format, industry and FDA liaison. ICH - Guidelines of ICH-Q, S E, M. Regulatory requirements of EU, MHRA, TGA and ROW countries.

MODULE-IV

Non clinical drug development: Global submission of IND,NDA, ANDA. Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB).

MODULE-V

Clinical trials: Developing clinical trial protocols. Institutional review board/ independent ethics committee Formulation and working procedures informed Consent process and procedures. HIPAA- new, requirement to clinical study process, pharmacovigilance safety monitoring in clinical trials.

Session Plan

Session 1

Documentation in Pharmaceutical industry

PDF- DOCUMENTATAION

Session 2

Master formula record

PDF- MFR

Session 3

DMF (Drug Master File), Distribution records.

PDF- 02DRUG MASTER FILE (DMF)

PDF-DISTRIBUTION RECORD

Session 4

Generic drugs product development

PDF-GENERIC DRUGS PRODUCT DEVELOPMENT

Session 5

Hatch-Waxman act and amendments

PDF- HATCH-WAXMAN ACT

Session 6

CFR (CODE OF FEDERAL REGULATION)

PDF- CFR

Session 7

Drug product performance  In-vitro

PDF- DRUG PRODUCT PERFORMANCE (1)

Session 8

ANDA regulatory approval process, NDA approval process

PDF-ANDA&NDA APPROVAL

Session 9

BE and drug product assessment, in –vivo

PDF-Bioequivalance and drug product assessment -in VIVO (1)

Session 10

Scale up process approval changes, post marketing surveillance

PDF-SUPAC (3)

Session 11

Outsourcing BA and BE to CRO.

PDF-OUTSOURCING (1)

Session 12

Regulatory requirement for product approval: API

PDF- API APROVALSAPI APROVALS

Session 13

Regulatory requirement for product approval: biologics, novel, therapies obtaining NDA

PDF- BIOLOGICS AND NOVEL THERAPIES

Session 14

ANDA for generic drugs ways and means of US registration for foreign drugs

PDF- FOREIGN DRUG APPROVAL

Session 15

CMC, post approval regulatory affairs

PDF- CMC

Session 16

Regulation for combination products and medical devices

PDF- Regulation for combination

Session 17

CTD and ECTD format

PDF-CTD & e-CTD

Session 18

Industry and FDA liaison.

PDF-INDUSTRY AND FDA LIAISON

Session 19

ICH - Guidelines of ICH-Q, S E, M.

PDF-ICH

Session 20

Regulatory requirements of EU, MHRA, TGA and ROW countries.

PDF-REGULATORY REQUIREMENTS

Session 21

Non clinical drug development: Global submission of IND,  NDA, ANDA.

PDF-Non clinical drug development

Session 22

Investigation of medicinal products dossier, dossier (IMPD)

PDF-IMPD

Session 23

Investigator brochure (IB)

PDF-I B

Session 24

Clinical trials: Developing clinical trial protocols.

PDF-clinical trial

Session 25

Institutional review board/ independent ethics committee Formulation and
working procedures

PDF- clinical trialClinical trials-1

Session 26

Informed Consent process and procedures

PDF- Informed consent process and procedures

Session 27

HIPAA- new, requirement to clinical study process

PDF- HIPPA

Session 28

Pharmacovigilance safety monitoring in clinical trials.

PDF- PHARCOVIGILANCE

REFERENCES

1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and IsaderKaufer,Marcel Dekker series, Vol.143
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 / Sandy Weinberg. 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. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https://www.tga.gov.au/tga-basics

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Gyanaranjan Parida

Assistant Professor
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