Course Objectives

This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs.

Learning Outcomes

On completion of this course it is expected that students will be able to understand

• Assist in Regulatory Audit process.
• Establish regulatory guidelines for drug and drug products
• The Regulatory requirements for contract research organization
• How to apply the knowledge and skill in drug regulation.

Course Syllabus

INTELLECTUAL PROPERTY RIGHTS (CUTM2003)

Scope
This course is designed to impart knowledge and skills necessary to train the students to be on
par with the routine of Industrial activities in drug regulatory affairs
Objectives
On completion of this course it is expected that students will be able to understand,
 Assist in Regulatory Audit process.
 Establish regulatory guidelines for drug and drug products
 The Regulatory requirements for contract research organization

THEORY 60 Hrs

1. Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to
be patentable, Introduction to patent search. Parts of patents. Filling of patents. The essential
elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in
Patent.
2 . Role of GATT, TRIPS, and WIPO
3. Brief introduction to Trademark protection and WHO Patents. IPR’s and its types, Major
bodies regulating Indian Pharmaceutical sector.
4. Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA
5. Regulatory requirements for contract research organization. Regulations for Biosimilars.

REFERENCES:
1. Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol 57, 2nd
Edition.
2. Applied Production and Operation Management By Evans, Anderson and Williams.
3. GMP for pharmaceuticals Material Management by K.K. Ahuja Published by CBS
publishers.
4. ISO 9000-Norms and explanations.
5. GMP for pharmaceuticals- Willing S.H. Marcel and Dekker.

Session Plan

Session 1

Introduction to intellectual property

Session 2

Introduction to regulatory audit process.

Session 3

Brief discussion on regulatory guidelines for drug and drug products.

Session 4

Introduction to patent definition and scope

Session 5

Need of patents and types of patent.

Session 6

Conditions to be satisfied by an invention to be patentable.

Session 7

Introduction to patent search.

Session 8

Parts of patent with samples.

Session 9

Filling of patent

Session 10

Essential element of  patent

Session 11

Guidelines for the preparation of laboratory note book.

Session 12

Non obviousness in patent.

Session 13

Sample of patent writing with guidelines.

Session 14

Introduction to GATT.

Session 15

Role of  GATT.

Session 16

Introduction to TRIPS.

Session 17

Role of  TRIPS.

Session 18

Introduction to WIPO.

Session 19

Role of WIPO.

Case Studies

Case Studies