Drug Regulatory Affairs and Intellectual Property Rights
Teacher
Lipsa samal
Category
Core Courses
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Code(Credit) : MGPH2104(4-0-0)
Course Objectives
- This course is designed to impart basic knowledge on regulatory authorities
- Idea about agencies governing the manufacture and sale of pharmaceuticals.
- Knowledge in IPR
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
Session 3
process, validation of manufacturing process
Session 4
Equipment, documentation, inspection requirement
Session 5
Regulatory guidelines for active ingredients and formulations.
Session 8
biological test, microbiological test and evaluation of closures.
Session 10
Overview of the drug regulatory aspects in countries- e.g. India, US and Europe.
Session 15
US DMF (various types), orange book, purple book and Hatch Waxman Act and 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 21
other federal laws affecting pharmaceutical industry (includes latest amendments in the Indian and international systems)
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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