InstructorKnowledge Process Enhancer
TypeOnline Course
Student Enrolled1
Price$650 / Rs. 32500
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Introduction

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Eligibility

Admission Process

Course Code: KPE-C-076

Course Title: Advance Diploma in Intellectual Property Right Management in Pharmaceutical and Biopharmaceutical Industry

Course Objectives:

Intellectual Property Right Management courses are conceptualized with vision to create effective IPR Manager for Pharmaceutical and biopharmaceutical Industry. This course gives practical knowledge of the functionalities of IPR Manager with practical exposure.

Career in IPR Management in Pharmaceutical, Biopharmaceutical Industry 

A career in IPR managemnet 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.

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.

Our Registerants are in Takeda, Pfizer, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.

  • 24×7 Online Access – Access anytime from anywhere across globe.
  • Prinatable booklet provided to all course participants. 
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 
  • Flexible online final examination (Computer Based Test by secure mode)
  • Real life Case Study module will be provided along with the course ,material. 

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

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ADMISSION PROCESS

Course Flow – 

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 67STRATEGIC ALLIANCES: CO-DEVELOPMENT AND CO-MARKETING AGREEMENTS
Lecture 68Due Diligence Activities in Pharmaceutical Licensing
Section 7Final Examination
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