TypeOnline Course
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Price$390 / Rs. 19500
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Admission Process

Admission Process

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certificate course in pharma business development and licensing

Introduction

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Eligibility

Admission Process

Course Code: KPE-C-080

Course Title: Certificate Course in  Pharma Business Development & Licensing

Course Mode: Online e-learning

Duration: 1 Month

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 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12Fundamental of clinical research
Section 2EU BD Fundamental - Drug Discovery, Development & Strategic Planning
Lecture 13Introduction to EU Regulation 
Lecture 14EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 15Overview of EU Regulation 
Lecture 16EMA and EMA Authorisation Process
Lecture 17EU MA Application Types and Strategic Planning
Lecture 18EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 19EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 20Validity 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 21Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 22EU Orphan Medicinal Products Regulation
Lecture 23Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 24EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 25EU Prime Designation 
Lecture 26Accelerated assessment by EMEA
Lecture 27EU Adaptive Pathway
Section 3Portfolio & Strategic Management
Lecture 28Portfolio Management in R&D Lifecycle 
Lecture 29Advance study on Para IV Filing
Lecture 30Para IV Notice
Lecture 31Evergreening - Patent Life Extension Strategies
Lecture 32Loss of Exclusivity (LOE) Strategies for Innovator Brands with case study
Lecture 33FTF - 180 Days Exclusivity
Lecture 34Strategic Planning in Combating 30 months stay strategies of innovator compan
Lecture 35Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Section 4Licensing in Pharma Industry (Advance Practical Understanding)
Lecture 36Types 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 37Licensing and Technology Transfer (TT)
Lecture 38In-Licensing Vs. Outlicensing
Lecture 39Licensing agreement Types - Advance Learning
Lecture 40Compulsory Licensing
Section 5Business Development Strategic Planning Process
Lecture 41Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 42Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 43Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 44Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 45Numerical SWOT Practical training
Lecture 46Modelling 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 47Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 48Forecasting : Tools and Techniques
Lecture 49Market Sizing & Forecasting Case Study
Lecture 50Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 51Average Royalty Rates
Lecture 52Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 53Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 54Acquisition in Pharmaceutical and Biopharmaceutical Brands and Business
Lecture 55Joint Venture - Key Insight
Lecture 56Special Purpose Vehicle (SPV)
Lecture 57Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 58Types of Deals from Discovery to Commerialication
Lecture 59Review: Fundamental Problem Area in Pharma Business Development
Lecture 60Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 61Licensing Payment Scheduling: Different Types
Lecture 62Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 63EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 64Negotiation 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 65Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 66Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 67Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 68Due Diligence Activities in Pharmaceutical Licensing
Section 6Final Examination
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