TypeOnline Course
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Pharma IPR Management course trains professionals in the intellectual property right in the domain of pharmaceutical, biopharmaceutical industry. This course gives practical knowledge of the functionalities of IPR Manager with practical exposure. 

  • Course Code: KPE-C-076
  • Course Title: Advanced Diploma in Pharma Intellectual Property Right Management (IPR)
  • Types of Course: Distance and e-learning ; Self Paced Learning

Intellectual property protection is critical to fostering innovation. Without protection of ideas, businesses and individuals would not reap the full benefits of their inventions and would focus less on research and development. And pharmaceutical industry is the research driven industry. Therefore, it is really important to have sound IPR strategy for pharma companies to be successful in market place. In this interactive course, we will be understanding how to create, manage and defend pharmaceutical innovations effectively. Moreover this course will provide comprehensive training how to use the advanced IPR tools.

The current pharmacy syllabus of most of the pharmacy courses do not provide adequate practical exposure on intellectual property right management, licensing business models of innovator & generic companies and the interplay of IPRs in the entire pharma R&D to commercialization cycle. This online course is aimed to fulfill these gaps and is uniquely designed for the pharmacy students, professionals and scientists working in the pharma industry so that they can learn the essentials and can better advance in their careers.

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or PhD holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. 3rd and final year student also can pursue this program.

Here the key features of the course.

  • Access the courses 24×7 at your convenience
  • Online interactive sessions with the expert Industry faculty
  • e-Library and e-pharma dictionary
  • Access to 1000’s of real life case studies
  • Online assignments & self Assessment Test
  • Printed Course Material
  • 24/7 Online Support With the Live Chat Facility
  • Special On demand Modules
  • Secure access to e-module with passwords.
  • Flexible online final examination (Computer Based Test by secure mode)
  • Our courses can be accessed anytime from anywhere

Career in IPR Management in Pharmaceutical, Biopharmaceutical Industry 

A career in IPR management is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in patent, trademark, copyright and licensing right management in pharmaceutical company. In all established pharmaceutical company there are dedicated IPR department  and they take care of filing of the patent, trademark, issuing and management of the licensing etc. They work in close proximity with strategic management, regulatory team in company.

Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Practical Training on Handling of orange book
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND
Lecture 12Patents Vs. exclusivity
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Section 2Clinical Trial / Research - Fundamental
Lecture 15Clinical Trial Detailed Study (Topic - 1-11)
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent
Lecture 19FDA forms and How to fill FDA forms
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3IPR Core Topics
Lecture 21Patent Office - Introduction and understanding of the functioning
Lecture 22Patent - Understanding Patentability, Novelty And Non-Obviousness, Conditions For Obtaining A Patent, Who can apply
Lecture 23Patent Application Process - USPTO
Lecture 24Trademark Search and Registration in US
Lecture 25Steps Know How & Key Points - Patent Application
Lecture 26IPR - Patent Grant and Handling Process in India (Optional)
Lecture 27Patent Search in Indian Patent Office (Optional)
Lecture 28Trademark - Practical on TM Search & Registration Process in India (Practical)
Lecture 29 Trademark Search assignment
Lecture 30Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4IPR Strategic Planning
Lecture 31Strategies in different phases of Clinical Trial
Lecture 32Advance study on Para IV Filing
Lecture 33Para IV Notice
Lecture 34Evergreening - Patent Life Extension Strategies
Lecture 35Pay For Delay Strategy
Lecture 36REMS Strategic Planning
Lecture 37Compulsory Licensing
Lecture 38Technology Licensing
Lecture 39In-Licensing Vs. Outlicensing
Lecture 40LOE Strategies for Innovator Brands with case study
Lecture 41Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 42Drug Re-purposing
Section 5Case Based learning sessions - IPR strategic planning
Lecture 43505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 44NCE Vs. 505b2 application - Case Based Learning 
Lecture 45FTF - 180 Days Exclusivity - Case Based Learning
Lecture 46Classic case study of the 505b2 filing
Lecture 47Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 48Asean Common Technical Document (ACTD) 
Lecture 49Discussion on 85 common deficiency in CTD submission dossier
Section 6Licensing in Pharma Industry (Advance Practical Understanding)
Lecture 50License Agreement - Introduction
Lecture 51Licensing and Technology Transfer (TT)
Lecture 52In-Licensing Vs. Outlicensing
Lecture 53Why would a pharma company look for in-licensing deals?
Lecture 54Licensing agreement Types - Advance Learning
Lecture 55Duration and Terms of License
Lecture 56Key understanding: Are improvements licensed?
Lecture 57Financial terms of license - Upfront, Milestone and Royalty
Lecture 58Calculation of Total Deal Value
Lecture 59Milestone Payment
Lecture 60Royalty Management - How are royalties structured in a license?
Lecture 61What accounts, inspection and audit provisions are in a license?
Lecture 62How is patenting dealt with in a license?
Lecture 63What warranties are in a license?
Lecture 64What competition law issues are there in licensing?
Lecture 65Quick Glance: What are the Disadvantages of the in-licensing deals?
Lecture 66Step by Step Implementation of the licensing deal
Lecture 68Due Diligence Activities in Pharmaceutical Licensing
Section 7Final Examination