TypeOnline Course
Price$390 / Rs. 19500
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Admission Process

Admission Process

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Introduction

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Eligibility

Admission Process

Course Code: KPE-C-078

Course Title: Advance Diploma in  Pharma Business Development & Licensing (ADBDL)

Course Mode: Online elearning

Course Objectives:

Pharmaceutical Business Development & Licensing courses are conceptualized with vision to create effective Business Development Manager for Pharmaceutical and biopharmaceutical Industry. This course gives practical knowledge of the functionalities of BD Manager with practical exposure.

Career in Business Development (BD) in Pharmaceutical, Biopharmaceutical Industry 

A career in Business Development (BD) is both a challenging and highly rewarding career in pharmaceutical and biopharmaceutical industry.  It opens up lot of opportunities as it covers a variety of disciplines. BD professionals involved in pipeline and portfolio management. In all established pharmaceutical company there are dedicated Business Development department (BD) 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.

BD professionals should have

1. In depth understanding of R&D – Discovery to Commercialization Process
2. Hands on knowledge on drug discovery, development and regulatory aspects of the market.
3. Market research skills to Conduct extensive market vigilance studies to monitor market dynamic.
4. Decision making skills to understand market analysis, technical and commercial feasibility
5. Advance licensing skills like identifying potential partners / distributors for new products, In-licensing, distribution, dormant licenses

BD professionals should have a strong Business Acumen & closely partner with Business needs and requirement.

The current pharmacy syllabus of most of the pharmacy courses do not provide adequate practical exposure on Business Development (BD) functionalities, licensing business models of innovator & generic companies and the BD functioning 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 1Advance Learning on R&D - Discovery to Commercialization Process
Lecture 1Drug Discovery - Development Process
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 Management in Pharma and Biopharma Industry
Lecture 21Patent office - Introductions
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
Lecture 31Patent Drafting
Lecture 32Patent Searching
Lecture 33Trademark Searching
Lecture 34Copyright - Advance Understanding
Lecture 35Geographic Indication
Lecture 36Patent Filing Process Handling
Lecture 37Trademark Filing Process Handling
Lecture 38Patent, Trademark, Copyright Renewals
Section 4Business Development Operations in Pharma and Biopharma Organization
Lecture 39Portfolio Management in R&D Life cycle 
Lecture 40Advance study on Para IV Filing
Lecture 41Para IV Notice
Lecture 42Evergreening - Patent Life Extension Strategies
Lecture 43Pay For Delay Strategy
Lecture 44REMS Strategic Planning
Lecture 45Compulsory Licensing
Lecture 46Technology Licensing
Lecture 47In-Licensing Vs. Outlicensing
Lecture 48Loss of Exclusivity (LOE) Strategies for Innovator Brands with case study
Lecture 49Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 50Drug Re-purposing
Lecture 51Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 52NCE Vs. 505b2 application - Case Based Learning 
Lecture 53FTF - 180 Days Exclusivity
Lecture 54Classic case study of the 505b2 filing
Lecture 55Strategic Planning in Combating 30 months stay strategies of innovator compan
Section 5Licensing in Pharma Industry (Advance Practical Understanding)
Lecture 56License Agreement - Introduction
Lecture 57Licensing and Technology Transfer (TT)
Lecture 58In-Licensing Vs. Outlicensing
Lecture 59Why would a pharma company look for in-licensing deals?
Lecture 60Licensing agreement Types - Advance Learning
Lecture 61Duration and Terms of License
Lecture 62Key understanding: Are improvements licensed?
Lecture 63Financial terms of license - Upfront, Milestone and Royalty
Lecture 64Calculation of Total Deal Value
Lecture 65Milestone Payment
Lecture 66Royalty Management - How are royalties structured in a license?
Lecture 67What accounts, inspection and audit provisions are in a license?
Lecture 68How is patenting dealt with in a license?
Lecture 69What warranties are in a license?
Lecture 70What competition law issues are there in licensing?
Lecture 71Quick Glance: What are the Disadvantages of the in-licensing deals?
Lecture 72Step by Step Implementation of the licensing deal
Lecture 73STRATEGIC ALLIANCES: CO-DEVELOPMENT AND CO-MARKETING AGREEMENTS
Lecture 74Due Diligence Activities in Pharmaceutical Licensing
Section 6Financials of Business Development
Lecture 75Basic Understanding financial accounting and reporting
Lecture 76Financial performance measurement and working capital and cash flow
Lecture 77Long term decision making
Lecture 78Financial modelling
Lecture 79Valuation methods and management of risks
Section 7Project Management Skill Training for Business Development professionals
Lecture 80Definition Review
Lecture 81Difference between Project and Program
Lecture 82Program/Project Leadership versus Stage
Lecture 83Project Management Constraint
Lecture 84Key to Project Success
Lecture 85PROJECT MANAGEMENT TOOLS AND TECHNIQUES - PERT, CPM, CRITICAL PATH, PROJECT DIAGRAM AND ITS COMPONENTS
Lecture 86Qualities of a Good Project Leader
Lecture 87Qualities of a Good Team Representative
Lecture 88Project Tracking in Drug Discovery Projects
Lecture 89What to Track in project?
Lecture 90Project Benchmarking through a Consortium
Lecture 91Cycle Times (Stage or phase lengths)
Lecture 92Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 93Challenges to Milestone Dates
Lecture 94Project Terminations
Lecture 95Project Re-initiations
Lecture 96Asset Tracking
Lecture 97Levels of Project and Portfolio Management
Section 8Negotiation Skill Training for BD professionals
Lecture 98Negotiation Skill Training for Pharma Business Development Manager
Lecture 99Communication Skill Training for Pharam Business Development Manager
Lecture 100Qualities of Pharma Business Development Manager
Lecture 101Ideal job description for pharma business development professionals
Lecture 102Career Growth Path in Pharma Business Development
Section 9Final Examination
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