Drug Regulatory Affairs and Intellectual Property Rights

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Lipsa samal

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Course Name :Drug Regulatory Affairs & Intellectual Property Rights

 

Code(Credit) : MGPH2104(4-0-0)

Course Objectives

This course is designed to impart basic knowledge on regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals.

Learning Outcomes

  • Critically examine and evaluate scientific data and conclusions intended for regulatory review.
  • Enable improvement of the regulatory environment by implementing and upholding good regulatory practices.
  • Take independent responsibility for own professional development.

Course Syllabus

Module I  

Manufacturing: Introduction, regulatory requirements as per Indian and other regulatory authorities for manufacturing information formula, process, validation of manufacturing process, equipment, documentation, inspection requirement, regulatory guidelines for active ingredients and formulations. Regulatory guidelines for packaging materials, test and evaluation of packaging materials, biological test, microbiological test and evaluation of closures.

Module II

National & International Drug Regulations:

CDSCO and State licensing authority, their functions and responsibilities.Overview of the drug regulatory aspects in countries- e.g. India, US and Europe.IND (Investigational New Drug), NDA (New Drug Application), Generic Drug ANDA Applications – an overview in India and other countries. Brief overview of CTD formats of dossiers, E-submission, US DMF (various types), orange book, purple book and Hatch Waxman Act and amendments.Federal Laws – FD & C Act - Definitions, History of FDA; Evolution of Drug Regulations – 1906 Act, 1938 Act, 1962 Amendments; Laws governing evaluation of New Drug products like IND, NDA, ANDA etc.; FDA Product recalls; DESI and OTC Review; Other regulations of 1962 Amendments like labelling requirements of prescription and OTC drugs.

Module III

FDA Enforcement powers, other federal laws affecting pharmaceutical industry (includes latest amendments in the Indian and international systems), Intellectual property rights: Introduction, purpose, guidelines as per Indian and other regulatory authorities.

Module IV

Product Life cycle: Clinical trials: Definition, Phase I, Phase II, Phase III and Phase IV studies, design documentation, presentation and interpretation, statistical analysis of clinical data, factorial design, guidelines as per Indian and other regulatory authorities.

Pharmacovigilance: aims and need for pharmacovigilance, types, predisposing factors and mechanism of adverse drug reactions (ADRs). Detection, reporting, management and monitoring of ADRs, role of pharmacists in pharmacovigilance.

Module V:

Intellectual Property Rights & Regulations

Overview of Intellectual Properties, their types and importance of intellectual property protection. Patents: Requirement of patenting, patent specifications and claims, Indian Patent act 1970 and amendments. Patent search, analysis, drafting and stages of filing patent at national level. Patent licensing, abuse of patents, infringements analysis, Compulsory licensing.

Paris Conventions, Patent Cooperation Treaty (PCT) – introduction, application and general rules. Patent search, analysis, drafting and stages of filing patent at international level. Introduction to concept behind WIPO / WTO / TRIPS / GATT / GATS system & Uruguay Round.

 Book References

  • Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and IsaderKaufer, Marcel Dekker series, Vol.143, Pharmaceutical Regulatory Process, Edited by Ira
  • Berry Marcel Dekker Series,Vol.144
  • New Drug Approval Process: Accelerating Global Registrations By Richard AGuarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
  • Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
  • Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel Dekker Series, 1995.
  • Country specific Regulatory Guidelines (available from internet): CDSO publications and updates of drug and Cosmetics act and rules (Govt. of India); CDER Publications and Guidance; EMEA Publications and Guidance; ICH guidelines.

Session Plan

Session 1

Session 2

Regulatory requirements as per Indian and other regulatory authorities for manufacturing information formula

GoodRegulatory_PracticesPublic by WHO PDF

Regulatory requirement for manufacturing pdf

Session 3

process, validation of manufacturing process

process validatin link

Process-Validation PDF

validation guideline pdf

Session 4

Equipment, documentation, inspection requirement

Equipment, documentation, inspection requirement pdf

Session 5

Regulatory guidelines for active ingredients and formulations.

Session 6

Regulatory guidelines for packaging materials, test

Session 7

Evaluation of packaging materials

Session 8

biological test, microbiological test and evaluation of closures.

Session 9

CDSCO and State licensing authority- their functions and responsibilities

Session 10

Overview of the drug regulatory aspects in countries- e.g. India, US and Europe.

Session 11

IND (Investigational New Drug)

Session 12

NDA (New Drug Application)

Session 13

Generic Drug ANDA Applications – an overview in India and other countries

Session 14

Brief overview of CTD formats of dossiers, E-submission

Session 15

US DMF (various types), orange book, purple book and Hatch Waxman Act and amendments

Session 16

Federal Laws – FD & C Act - Definitions, History of FDA

Session 17

Evolution of Drug Regulations – 1906 Act, 1938 Act, 1962 Amendments

Session 18

Laws governing evaluation of New Drug products like IND, NDA, ANDA etc.; FDA Product recalls

Session 19

DESI and OTC Review; Other regulations of 1962 Amendments like labelling requirements of prescription and OTC drugs.

Session 20

FDA Enforcement powers

Session 21

other federal laws affecting pharmaceutical industry (includes latest amendments in the Indian and international systems)

Session 22

Intellectual property rights: Introduction, purpose

Session 23

Intellectual property rights: guidelines as per Indian and other regulatory authorities.

Session 24

Clinical trials: Definition, Phase I, Phase II, Phase III and Phase IV studies

Session 25

design documentation, presentation and interpretation

Session 26

statistical analysis of clinical data

Session 27

factorial design and Product Life cycle

Session 28

clinical trails: guidelines as per Indian and other regulatory authorities

Session 29

Pharmacovigilance: aims and need for pharmacovigilance, types, predisposing factors

Session 30

mechanism of adverse drug reactions (ADRs).

Session 31

Detection, reporting, management and monitoring of ADRs

Session 32

Role of pharmacists in pharmacovigilance

Session 33

Overview of Intellectual Properties, their types and importance of intellectual property protection.

Session 34

Patents: Requirement of patenting, patent specifications and claims

Session 35

Indian Patent act 1970 and amendments

Session 36

Patent search, analysis, drafting and stages of filing patent at national level

Session 37

Patent licensing, abuse of patents, infringements analysis, Compulsory licensing.

Session 38

Paris Conventions, Patent Cooperation Treaty (PCT) – introduction, application and general rules

Session 39

Patent search, analysis, drafting and stages of filing patent at international level.

Session 40

Introduction to concept behind WIPO / WTO / TRIPS / GATT / GATS system & Uruguay Round.

Case Studies

Case Studies

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