InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 22500 INR.
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pharmaceutical ipr management

Introduction

Feature

Course Duration

Eligibility

About Pharma IPR Management

pharmaceutical IPR Management

Pharmaceutical IPR Management course trains professionals with practical knowledge of the functionalities of intellectual property management. The course provides training on patent, trademark, copyright, etc. with real life simulation and case studies. Moreover the course provide advanced training in licensing in pharmaceutical and biopharmaceutical industry.

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 and generic companies. This online course bridge this gaps. Hence, Pharmaceutical IPR Management course is ideal for pharmacy students. At the same time, this course equally benefits the strategic management professionals and scientists working in the pharma industry. This helps them to  learn the essentials of intellectual property right.

Course Title: Advance Certification in Pharmaceutical IPR Management

Course Code: RYD-042

Features of the Course:

  • The course provide practical training on IPR management practices. Therefore it helps the students to identify the IPR tools and techniques which commonly used in pharmaceutical industry.
  • Simulation to real life working in licensing, technology transfer and litigation management.
  • The course provides clear cut understanding how IPR management helps in Decision Making and Strategic Planning and new product innovation.
  • Above all, this course provide access to Online Data bank of pharma IPR case studies. Certainly, accessing these case studies can be helpful for students to understand various strategies used in industry.

1 month.

Graduation in any discipline. Final year graduation students can join this course.

Career in IPR Management in Pharmaceutical, Biopharmaceutical Industry 

A career in IPR management is both a challenging and highly rewarding career. Therefore, 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. Hence, they work in close proximity with strategic management, regulatory team in company.

How IPR plays a role in pharmaceutical industry?

IPR is a prerequisite for pharma companies for identification, planning, commercialization, and protection of invention. It is also an important tool to protect investment, time, and effort and encourages healthy competition—thus promoting industrial development and economic growth. IPRs also provide incentives to pharma companies to invest in research and development.

It is important to have well defined practice of IPR management skill for pharmaceutical companies. In turn, it helps organization to be robust and strong in innovation management.

In fact, the IPR management directly link with product development. Hence, by focusing on IP strategy, companies can avoid litigation that might lead to financial loss to the company. Moreover, they can exploit IP-related products through commercialization and licensing. Above all, this increases the demand of low-value drugs and rapid growth of pharma companies.

Section 1Pharma and Biopahrma R&D Fundamental : Discovery to Development Stages
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7Clinical Research
Lecture 8Clinical Trial Protocol Writing
Lecture 9Ethics in Clinical Research
Lecture 10Informed Consent 
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12Orphan Drug Designation 
Lecture 13USFDA expedited programs
Lecture 14Biological Licensing Application (BLA) 
Lecture 15Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 16Purple Book: Significance | Searching | Assignments
Lecture 17Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Section 2Innovation and IPR Management in Pharma and Biopahrma Industry
Lecture 18Introduction to intellectual Property Management
Lecture 19Introduction to Patent 
Lecture 20Understanding on Patent System
Lecture 21Steps Know How & Key Points - Patent Application 
Lecture 22Patent Grant and Managing Patent Filing Procedure
Lecture 23Scope of Patentability 
Lecture 24Patent Grant and Handling Process in India 
Lecture 25Stages of Patent Grant Procedure
Lecture 26Patent search in Indian Patent Office
Lecture 27Differences in US and European Patent
Lecture 28Patent Claim | Types of Patent Claims 
Lecture 29Patent Cliff | How to calculate the patent cliff
Lecture 30Terminologies related to patent, trademark, copyright and licensing 
Lecture 31Patent Infringement
Lecture 32Introduction to Trademark | Trademark filing procedure
Lecture 33Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 34Trademark Infringement | Passing off | Practical Cases
Lecture 35Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3IPR Strategic Management
Lecture 36Strategies in different phases of Clinical Trial
Lecture 37Authorized Generics: Key Understanding
Lecture 38Advance study on Para IV Filing
Lecture 39Para IV Notices
Lecture 40Evergreening - Patent Life Extension Strategies
Lecture 41Pay For Delay Strategy
Lecture 42Compulsory Licensing
Lecture 43Licensing & Technology Transfer
Lecture 44In-Licensing Vs. Outlicensing
Lecture 45LOE Strategies for Innovator Brands with case study
Lecture 46Advance Learning on 505B2 Pathway
Lecture 47Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 48NCE Vs. 505b2 application - Case Based Learning 
Lecture 49FTF - 180 Days Exclusivity - Case Based Learning
Lecture 50Classic case study of the 505b2 filing : Case Based Learning
Lecture 51Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 52Licensing and Technology Transfer
Lecture 53Licensing - Advance Learning 
Lecture 54Due Diligence Activities in Pharmaceutical Licensing
Section 4Advanced Licensing Training | Asset Management | Deal Structuring
Lecture 55Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 56Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 57Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 58Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 59Average Royalty Rate
Lecture 60Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 61Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 62Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 63Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 64Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 65Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 66Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 67Early Stage VS. Late Stage Valuation Methodology | Stair Step Model