TypeOnline Course
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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 1US BD Fundamental - Drug Discovery to Development
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 6Detailed learning on clinical trials and related terminologies
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 
Lecture 15Orphan Drug Designation 
Lecture 16Advance Strategic Learning on 505B2 Pathway
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2EU BD Fundamental - Drug Discovery, Development & Strategic Planning
Lecture 18Introduction to EU Regulation 
Lecture 19Orientation to European Countries and National Regulatory Bodies
Lecture 20EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 21Overview of EU Regulation 
Lecture 22EMA and EMA Authorisation Process
Lecture 23EU MA Application Types and Strategic Planning
Lecture 24EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 25EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 26Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 27Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 28EU Orphan Medicinal Products Regulation
Lecture 29Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 30Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 31EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 32EU Prime Designation 
Lecture 33Accelerated assessment by EMEA
Lecture 34EU Adaptive Pathway
Lecture 35European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 36SPOR  - Concept of Master Data Management  
Lecture 37The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 3IPR Management in Pharma and Biopharma Industry
Lecture 38Patent office - Introductions
Lecture 39Patent - Understanding Patentability, Novelty And Non-Obviousness, Conditions For Obtaining A Patent, Who can apply
Lecture 40Patent Application Process - USPTO
Lecture 41Trademark Search and Registration in US
Lecture 42Steps Know How & Key Points - Patent Application
Lecture 43IPR - Patent Grant and Handling Process in India (Optional)
Lecture 44Patent Search in Indian Patent Office (Optional)
Lecture 45Trademark - Practical on TM Search & Registration Process in India (Practical)
Lecture 46 Trademark Search assignment
Lecture 47Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Portfolio & Strategic Management
Lecture 48Portfolio Management in R&D Lifecycle 
Lecture 49Advance study on Para IV Filing
Lecture 50Para IV Notice
Lecture 51Evergreening - Patent Life Extension Strategies
Lecture 52Pay For Delay Strategy
Lecture 53REMS Strategic Planning
Lecture 54Compulsory Licensing
Lecture 55Technology Licensing
Lecture 56In-Licensing Vs. Outlicensing
Lecture 57Loss of Exclusivity (LOE) Strategies for Innovator Brands with case study
Lecture 58Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 59Drug Re-purposing
Lecture 60Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 61NCE Vs. 505b2 application - Case Based Learning 
Lecture 62FTF - 180 Days Exclusivity
Lecture 63Classic case study of the 505b2 filing
Lecture 64Strategic Planning in Combating 30 months stay strategies of innovator compan
Section 5Licensing in Pharma Industry (Advance Practical Understanding)
Lecture 65Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms 
Lecture 66Licensing and Technology Transfer (TT)
Lecture 67In-Licensing Vs. Outlicensing
Lecture 68Licensing agreement Types - Advance Learning
Section 6Financials of Business Development
Lecture 69Basic Understanding financial accounting and reporting
Lecture 70Financial performance measurement and working capital and cash flow
Lecture 71Long term decision making
Lecture 72Financial modelling
Lecture 73Valuation methods and management of risks
Section 7Project Management Skill Training for Business Development professionals
Lecture 74Definition Review
Lecture 75Difference between Project and Program
Lecture 76Phasing of Projects for better effectiveness / outcome of the Project 
Lecture 77Project Management Constraint
Lecture 78Key to Project Success
Lecture 79PROJECT MANAGEMENT TOOLS AND TECHNIQUES - PERT, CPM, CRITICAL PATH, PROJECT DIAGRAM AND ITS COMPONENTS
Lecture 80Qualities of a Good Project Leader
Lecture 81Qualities of a Good Team Representative
Lecture 82Project Tracking in Drug Discovery Projects
Lecture 83What to Track in project?
Lecture 84Project Benchmarking through a Consortium
Lecture 85Cycle Times (Stage or phase lengths)
Lecture 86Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 87Challenges to Milestone Dates
Lecture 88Project Terminations
Lecture 89Project Re-initiations
Lecture 90Asset Tracking
Lecture 91Levels of Project and Portfolio Management
Section 8Business Development Strategic Planning Process
Lecture 92Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 93Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 94Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 95Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 96Numerical SWOT Practical training
Lecture 97Modelling 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 98Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 99Forecasting : Tools and Techniques
Lecture 100Market Sizing & Forecasting Case Study
Lecture 101Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 102Average Royalty Rates
Lecture 103Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 104Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 105Acquisition in Pharmaceutical and Biopharmaceutical Brands and Business
Lecture 106Joint Venture - Key Insight
Lecture 107Special Purpose Vehicle (SPV)
Lecture 108Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 109Types of Deals from Discovery to Commerialication
Lecture 110Review: Fundamental Problem Area in Pharma Business Development
Lecture 111Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 112Licensing Payment Scheduling: Different Types
Lecture 113Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 114EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 115Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 116Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 117Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 118Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 119Due Diligence Activities in Pharmaceutical Licensing
Lecture 120
Section 9Final Examination
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