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Pharmaceutical Global Business Course


Course Description

Course Objective

Course duration




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Course Code: KPE-C-024

Course Title: KPE’s Advance Diploma in Pharmaceutical Global Business

Course Objective: Executive Program in Pharmaceutical Global Business is conceptualized with vision to enhance competency of middle and middle / top level managers who are working in pharmaceutical, bio-pharmaceuticals industry. This course ideally developed for the working professionals of pharmaceutical and biopharmaceutical industry.

Course Description

Unlike other management business courses that concentrate narrowly on a diverse function or piece of the business—accounting, finance, marketing, production, human resources, or information systems, strategic management is a big picture course.
This course focus on the real life working on the whole spectrum of pharmaceutical and bio-pharmaceutical strategic business and management. The centre of attention is the total pharma and biopharma enterprise–-the industry and competitive environment in which it operates, its long-term direction and strategy, its resources and competitive capabilities, and its prospects for success. pharma global business online course
Throughout the course, the spotlight will be trained on the foremost issue in running a pharmaceutical and biopharmaceutical business enterprise: “What must managers do, and do well, to make the pharmaceutical company a winner in the game of business?”
The answer that emerges, and which becomes the theme of the course, is that good strategy-making and good strategy-execution are the key ingredients of company success and the most reliable signs of good management. The mission of the course is to explore why good strategic management leads to good business performance, to present the basic concepts and tools of strategic analysis, and to drill you in the methods of crafting a well-conceived strategy and executing it competently. You’ll be called on to probe, question, and evaluate all aspects of a company’s external and internal strategic situation. You’ll grapple with sizing up a company’s standing in the marketplace and its ability to go head-to-head with rivals, learn to tell the difference between winning strategies and mediocre strategies, and become more skilled in spotting ways to improve a company’s strategy or its execution. In the midst of all this, another purpose is accomplished: to help you synthesize what you have learned in prior business courses. Dealing with the grand sweep of how to manage all the pieces of a business makes strategic management an integrative, KPE’s Executive Program in Pharmaceutical Global Business course in which you’ll see how the various pieces of the business puzzle fit together and why the different parts of a business need to be managed in strategic harmony for the organization to operate in winning fashion.

Objective of the course

• To develop your capacity to think strategically about a company, its present business position, its long-term direction, its resources and competitive capabilities, the caliber of its strategy, and its opportunities for gaining sustainable competitive advantage.

• To build your skills in conducting branding activities and strategic analysis in a variety of competitive situations and, especially, to provide you with a stronger understanding of the competitive challenges of a global pharmaceutical environment.

• To give you hands-on experience in crafting pharmaceutical branding, business strategy, reasoning carefully about strategic options, using what-if analysis to evaluate action alternatives, and making sound strategic decisions.

• To acquaint you with the managerial tasks associated with implementing and executing company strategies, drill you in the range of actions managers can take to promote competent strategy execution, and give you some confidence in being able to function effectively as part of a company’s strategy-implementing team.

• To develop your powers of managerial judgment, help you learn how to assess business risk, and improve your ability to make sound decisions and achieve effective outcomes.

Course Duration

1 Year from the date of admission.

Features of the course

  • 24×7 online access – learn at your convenience.
  • Orientation to job related practical aspects of different domain of the pharmaceutical and biopharmaceutical operations.
  • Simulation to real life working to enhance the practical skills.
  • Access to Industry Databank.
  • Access to 1000’s of Pharmaceutical Case Studies.
  • Attend Lectures of all different chapters / study content.

Minimum qualification Graduation in any discipline with more than 60 months (5 Years)  of work experience in middle and top management. Work Experience is mentioned is mandatory for admission into this course. Work Experience certificate / proof need to be provided at the time of admission.


Frequently asked questions

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  • Upon completion of the admission process, 34 Modules  in the form of printable e-book will be available for download. All books can be downloaded by visiting your dashboard.
  • Immediately upon admission, course participant will be provided with user id and password to access his/her personalized web page through which he can access e-lectures, cases studies, etc. across from anywhere using internet.

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  • The participants of Global Business Registrant will get two add on certification.
  • Participant can choose add on courses of any 1 month or 1 week certification course.
  • There will be no fees  for add on courses and courses can be opted any time during the Global Business Course access period.
  • On completion of add on course, participant will be issuing course certificate.

Course Syllabus & Orientation:

Section 1Global Pharmaceutical R&D: Discovery to Development
Lecture 1Drug Regulation Fundamentals
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) Filing
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10USFDA expedited programs
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12Practical Training on INDA, NDA, ANDA filing
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 17Orphan Drug & Orphan Drug Act
Lecture 18Clinical Research : Detailed Understanding
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent 
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Section 2Innovation Management in Pharmaceutical & Biopharmaceutical Industry
Lecture 26USPTO - Introduction
Lecture 27Patent
Lecture 28Patent - Practical on search and filing - USPTO
Lecture 29Trademark - Practical on TM Search & Registration Process - USPTO
Lecture 30Trademark - Practical on TM Search USPTO
Lecture 31Trademark Search assignment USPTO
Lecture 32Patent - Practical on search and filing in Indian Patent Office
Lecture 33Trademark - Practical on TM Search & Registration Process in India
Lecture 34Trademark Search assignment (India)
Lecture 35Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 3Advance Strategic Management
Lecture 36Understanding of Regulatory Strategies
Lecture 37Advance study on Para IV Filing
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Drug Repurposing
Lecture 40Pay For Delay Strategy
Lecture 41Pediatric Exclusivity - Case Study
Lecture 42Compulsory Licensing
Lecture 43Technology Licensing
Lecture 44Drug Pipeline and In / Outlicensing
Section 4Basic Fundamental of Pharma Production & Plant Management
Lecture 45Definition of GMP
Lecture 46Introduction to Good Manufacturing Practices
Lecture 47Premises & Plant Layout Designing
Lecture 48Sanitation and Hygiene
Lecture 49Equipment Modules
Lecture 50Production Modules
Lecture 51Documentation
Lecture 52Quality Control
Lecture 53G7 Lecture Product Complaint
Lecture 54G8 Lecture Storage Module
Lecture 55ISO and ISO Audits
Lecture 56Pharmaceutical SOPs Management from regulatory perspective
Lecture 57SOP Automation in Pharmaceutical Industry
Lecture 58USFDA warning Letter & CAPA
Lecture 59USFDA Warning Letter
Lecture 60Handling of warning letter
Lecture 61Case Study - Warning Letter
Lecture 62Detailed Understanding of DMF & SMF
Section 5Global Business : European Union - Regulatory & Strategic Planning
Lecture 63Introduction to EU Regulation 
Lecture 64Orientation to European Countries and National Regulatory Bodies
Lecture 65Orientation to European Countries and National Regulatory Bodies
Lecture 66Overview of EU Regulation
Lecture 67EMA and EMA Authorisation Process
Lecture 68Summary of Product Characteristics
Lecture 69Compassionate Use
Lecture 70EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 71Validity 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 72Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 73EU Orphan Medicinal Products Regulation
Lecture 74Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 75Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 76Summary of Product Characteristics 
Lecture 77Compassionate Use
Lecture 78MHRA - UK Regulation 
Lecture 79The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 80EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 81EU Prime Designation 
Lecture 82Accelerated assessment by EMEA
Lecture 83EU Adaptive Pathway
Lecture 84European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 85SPOR  - Concept of Master Data Management  
Section 6Global Business : GCC countries
Lecture 86GCC Pharma Market
Lecture 87GCC Export – Local Partner
Lecture 88GCC Registration Procedure
Lecture 89Documentation Required for the GCC countries
Lecture 90Drug Registration in Saudi Arabia
Lecture 91Drug Registration in UAE
Lecture 92Drug Registration in Kuwait
Lecture 93Drug Registration in Bahrain
Lecture 94Drug Registration in Oman
Section 7Drug Registration Dossier
Lecture 95Introduction to Common Technical Document (CTD)
Lecture 96Asean Common Technical Document (ACTD)
Lecture 97Introduction to Electronic Common Technical Document (ECTD)
Lecture 98Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 99Modules on Stability Study 1
Section 8Global Business : ASEAN countries
Lecture 100ASEAN Drug Regulatory Affairs
Lecture 101Asean Geography
Lecture 102Drug Registration in Brunei
Lecture 103Drug Registration in Malaysia
Lecture 104Drug Registration in Cambodia
Lecture 105Drug Registration in Mayanmar
Lecture 106Drug Registration in Philippines
Lecture 107Drug Registration in Singapore
Section 9Pharmaceutical Business in India
Lecture 108Drug Regulation in India - CDSCO
Lecture 109National Pharmaceutical Pricing Authority
Lecture 110Drug Price Regulation in India
Lecture 111Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 112Drug Price Control Order 2013
Lecture 113Case Study of New Drug Approval in India
Section 10Introduction to Pharma Product Management
Lecture 114Introduction to Pharma Product Management
Lecture 115Detailed Understanding of Product Management Job
Lecture 116Classification of Doctors
Section 11Marketing Orientation for Product Manager
Lecture 117Marketing Orientation for Product Manager
Lecture 118Why Is Market Research Important in Pharmaceutical Business?
Lecture 119Product Life cycle 
Lecture 120Advance - Strategic Planning in Product Life cycle Management
Lecture 121Segmentation
Lecture 122Pricing
Lecture 123Distribution Channel in Pharmaceutical Industry 
Lecture 124A Pharmaceutical Segmentation outlook
Lecture 125Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 126Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 127Setting and Quantifying Promotional Objectives
Lecture 128Break even analysis
Lecture 129Method of Promotional Budgeting
Lecture 130Basics of Advertising
Lecture 131The Advertising agency
Lecture 132Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 133Advertising Planning - ATL, BTL, TTL activities
Lecture 134Target Audiences for Pharma Promotion : Types and Specialization
Lecture 135Business segments of Pharmaceutical Companies
Lecture 136Target Audience Selection Based on Products
Section 12Practical Training on Pharma Brand Logo Development
Lecture 137Brand Logo - Introduction
Lecture 138Purpose of Brand Logo
Lecture 139Component of Brand Logo
Lecture 140Trademark Registration
Lecture 141Trademark - Practical on TM Search
Lecture 142Trademark Search assignment
Lecture 143How to design excellent brand logo?
Lecture 144How to design excellent brand logo?
Lecture 145Color Systems - RGB & CMYK
Lecture 146Few Case Studies related to brand names and logos
Lecture 147Brand Logo - Simulation
Lecture 148Colour Trademarking in Pharma Branding
Lecture 149How to protect pharma brands globally?
Lecture 150Rebranding in Pharmaceuticals
Lecture 151Brand Logo Development: Real Life Simulation
Lecture 152Brand Tagline - Punchline
Lecture 153Pharma Brand Name Generator
Section 13Advance Pharma Brand Management - 1
Lecture 154Fundamental of Pharma Marketing Plan 
Lecture 155Basic Understanding how to launch a pharmaceutical product into the market 
Lecture 156Practical Training on Marketing Plan Preparation with real life example
Lecture 157Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 158New Product Launch Framework
Lecture 159Sectional Development of Marketing Plan
Lecture 160Decide about brand USP -What to promote 
Lecture 161Sample Marketing Plan : Febuxostat
Lecture 162How to prepare promotogram. Download sample Promotogram
Lecture 163Importance and Handling of Cycle Meeting and its importance 
Lecture 164Brand Launch Case Study
Lecture 165Aristada - Launch Case Study
Lecture 166CSR Campaign
Lecture 167Cost Based Working for Sample Allocation
Lecture 168Increase the brand reach with advance segmentation
Lecture 169Concept of uniform branding for better brand acceptability
Lecture 170Concept of Brand Differentiation
Lecture 171Brand Plan to Marketing Campaign - Objective setting to effective execution
Section 14Advance Pharma Brand Management - 2
Lecture 172Importance of Visual Aid in Pharmaceutical Industry
Lecture 173Fundamentals of preparing visual aid
Lecture 174Indications for Drugs: Approved vs. Non-approved
Lecture 175Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 176Step by step visual aid development process
Lecture 177 Guideline of Visual Aid Designing
Lecture 178Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 180Detailing and e-detailing
Lecture 181Visual Aid Development Process Review
Lecture 182Visual Aid, Literature reference Sample
Lecture 183Tablet vs. Conventional Detailing
Lecture 184Celebrity Endorsement in Pharmaceuticals
Lecture 185Conference Management
Section 15Practical Training on Packaging Development
Lecture 186Artwork Development Process in PMT Department
Lecture 187Product List and Reminder card development
Lecture 188Catch Cover Development
Lecture 189Packaging Development
Lecture 190Prescribing Information and Patient Information Leaflet development
Lecture 191Pharma Packaging Case Studies
Section 16Analytics
Lecture 192Moving annual total (MAT)
Lecture 193Compound Annual Growth Rate (CAGR)
Lecture 194Analytical Approach in Determining Brand Potential with case study
Section 17Advance Strategic Management
Lecture 195Co-promotion & Co-marketing strategy in pharma industry
Lecture 196Concept of Reverse co-promotion in pharma industry
Lecture 197In-Licensing Vs. Outlicensing
Lecture 198Importance of Publications in Pharmaceutical Industry
Lecture 199Juxtapid Case Study
Lecture 200New Indication Approval Process and Promotion
Section 18Fundamental understanding in Finance
Section 19Access to Case study directory
Section 20Project & Portfolio Management
Lecture 203Introduction: Project Management
Lecture 204Difference between Project and Program
Lecture 205Program/Project Leadership versus Stage
Lecture 206Project Management Constraint
Lecture 207Key to Project Success
Lecture 208PERT, CPM, Critical Path, Project Diagram and its components
Lecture 209Qualities of a Good Project Leader
Lecture 210Qualities of a Good Team Representative
Lecture 211Project Tracking in Drug Discovery Projects
Lecture 212Project Benchmarking through a Consortium
Lecture 213Cycle Times (Stage or phase lengths)
Lecture 214he proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 215What is a milestone chart?
Lecture 216Project Termination and Project Reinitiation
Lecture 217Asset Tracking
Lecture 218Levels of Project and Portfolio Management
Lecture 219Functions of Portfolio Management Team
Lecture 220Importance of Periodic Portfolio Reviews
Lecture 221Portfolio Prioritization
Section 21Business Development Skill Training
Lecture 222Pharma BusiBusiness Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 223Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 224Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 225Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 226Numerical SWOT Practical training
Lecture 227Modelling 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 228Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 229Forecasting : Tools and Techniques
Lecture 230Market Sizing & Forecasting Case Study
Lecture 231Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 232Average Royalty Rates
Lecture 233Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 234Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 235Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 236Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 238Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 239Types of Deals from Discovery to Commerialication
Lecture 240Review: What are the fundamental areas of business development
Lecture 241Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 242Licensing Payment Scheduling: Different Types
Lecture 243Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 244Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 245Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 246Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 247Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 248Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 249Due Diligence Activities in Pharmaceutical Licensing
Lecture 250Pharma Business Development - Competency Test. Check your competency