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KPE - C- 024 KPE's Executive Program in Pharmaceutical Global Business


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pharma global business course

Executive Program in Pharmaceutical Global Business provides hands on training to enhance skill competency of middle and top level managers. This course suits for the working professionals of pharmaceutical and biopharmaceutical industry. In this self paced learning, one can experience the real life work simulations for pharma and biopharmaceutical industry. Skills which are most necessary for successful in the biopharmaceutical and pharmaceutical competitive landscape is covered in depth. 

  • Code: KPE-C-024
  • Course Title: KPE’s Advance Diploma in Pharmaceutical Global Business
  • Type of the course: Self paced Online Course

Course Description

Executive Program in Pharma Global Business is little different from other other management business courses. Other Business Management courses concentrate narrowly on a diverse function or piece of the business—accounting, finance, marketing, production, human resources, or information systems, strategic management. But here it is strategic management
This course focus on the real life working on the whole spectrum of pharmaceutical and bio-pharmaceutical strategic business and management. The center 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.

Key factor

pharma global business online courseThroughout 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?

Strategic Orientation

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.

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

  • The course helps participant to think strategically about a pharmaceutical and Biologic 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 develop clear cut understanding on drug discovery to development to commercialization process effectively, to strategise the pharmaceutical business in regulated, semi-regulated and unregulated market. Pharmaceutical Global Business Course
  • Executive Program in Pharmaceutical Global Business provides the skill training regarding 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 business 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.
  • This Global Pharma Business course helps one to acquaint with the managerial tasks associated with implementing and executing company growth strategies, drill 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.
  • The course helps to develop the decision making skills for managers. Therefore, it helps one to 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 self paced online learning  – learn at your convenience. 
  • Courses can be accessed at your own convenient time.
  • Downloadable PDF study modules.
  • E-lectures for easy understanding of the concepts.
  • Self assessment concept checkers for each lecture. 
  • Simulation to real life working. 
  • Access to case studies. 
  • Unique personalized course tracking page with course performance analytics. 
  • Flexible online final examination (Computer Based Test by secure mode).  
  • Course certification –  Course completion and Course gradation certificate. 

Minimum qualification for participation of this course is Graduation in any discipline with more than 24 months of work experience in middle and top management. Work Experience is mandatory for admission into this course.

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Admission Process

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Past performer

Prospect identification process – top performer in course since 2012

  • Course contains 34 study modules in the form of eBooks. Therefore, you can save the eBooks in your system.
  • You can download the study modules by login to your dashboard.
  • Immediately upon admission, course participant can instantly accessing the course.
  • Executive Program in Global Pharmaceutical Business is online 24×7 learning. Hence, course participants can access the lectures at their own convenience.
  • While attending lectures, course participant can also download the lecture handout and save for reference.

  • 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.
  • Participant can activate the add on course anytime during 1 year active course duration.
  • On completion of add on course, participant will be issuing course certificate.
  • You can activate this add on course anytime during the active 1 year course tenure.

Strategic Management Courses


Department / Functional Area

Pharma Global Business – Executive Program

Strategic Management, BD, Licensing, International Marketing, Product Management, Regulatory department,Top-Middle Management Corporate employees

Business Development and Licensing

Business Development and Licensing

Inlicensing and Outlicensing

BD, In and Outlicensing Department

Pharma Strategic Management

Strategic Management, BD, Licensing, International Marketing, Top-Middle Management Corporate employees

Biopharma Global Business

Biopharma Strategic Management, BD, Licensing, International Marketing, Product Management, Regulatory department, Top-Middle Management Corporate employees.

Market Access

Biopharma Strategic Management, Market Access.

Pharma International Business Management

Export, International Marketing, International Brand Management professionals

Market Access Courses


Department / Functional Area

Market Access & Pricing


Pharma Forecasting


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 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
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 21FDA Forms and How to fill the resources
Lecture 22Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 23Advance Learning on 505B2 Pathway
Lecture 24Importance and Significance of Phase 2b Clinical Trial 
Lecture 25Informed Consent | Practical Training on Preparing ICF | Templates
Section 2Innovation Management in Pharmaceutical & Biopharmaceutical Industry
Lecture 26Introduction to intellectual Property Management
Lecture 27Introduction to Patent 
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 31IPR - Patent Grant and Handling Process in India
Lecture 32Stages of Patent Grant Procedure
Lecture 33Patent search in Indian Patent Office
Lecture 34Differences in US and European Patent
Lecture 35Patent Claim | Types of Patent Claims 
Lecture 36Patent Cliff | How to calculate the patent cliff
Lecture 37Terminologies related to patent, trademark, copyright and licensing 
Lecture 38Patent Infringement
Lecture 39Introduction to Trademark | Trademark filing procedure
Lecture 40Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 41Trademark Infringement | Passing off | Practical Cases
Lecture 42Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3Global Strategic Management
Lecture 43Understanding of Regulatory Strategies
Lecture 44Advance study on Para IV Filing
Lecture 45Para IV Notices
Lecture 46Evergreening - Patent Life Extension Strategies
Lecture 47Pay For Delay Strategy
Lecture 48REMS Strategic Planning 
Lecture 49Compulsory Licensing
Lecture 50Licensing & Technology Transfer
Lecture 51In-Licensing Vs. Outlicensing
Lecture 52LOE Strategies for Innovator Brands with case study
Lecture 53Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 54Drug Repurposing
Lecture 55Licensing - Advance Learning 
Lecture 56Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 57NCE Vs. 505b2 application - Case Based Learning 
Lecture 58FTF - 180 Days Exclusivity - Case Based Learning
Lecture 59Classic case study of the 505b2 filing : Case Based Learning
Lecture 60Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 61Pipeline in a Molecule
Lecture 62Emergency Use Authorization (EUA)
Section 4Basic Fundamental of Pharma Production & Plant Management
Lecture 63Definition of GMP
Lecture 64Premises & Plant Layout Designing
Lecture 65Sanitation and Hygiene
Lecture 66Equipment Modules
Lecture 67Production Modules
Lecture 68Documentation
Lecture 69Quality Control
Lecture 70G7 Lecture Product Complaint
Lecture 71G8 Lecture Storage Module
Lecture 72ISO and ISO Audits
Lecture 73CAPA
Section 5Global Business : European Union - Regulatory & Strategic Planning
Lecture 74Introduction to EU Regulation 
Lecture 75Orientation to European Countries and National Regulatory Bodies
Lecture 76Orientation to European Countries and National Regulatory Bodies
Lecture 77Overview of EU Regulation
Lecture 78EMA and EMA Authorisation Process
Lecture 79Summary of Product Characteristics
Lecture 80Compassionate Use
Lecture 81EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 82Validity 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 83Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 84EU Orphan Medicinal Products Regulation
Lecture 85Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 86Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 87Summary of Product Characteristics 
Lecture 88Compassionate Use
Lecture 89MHRA - UK Regulation 
Lecture 90The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 91EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 92EU Prime Designation 
Lecture 93Accelerated assessment by EMEA
Lecture 94EU Adaptive Pathway
Lecture 95European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 96SPOR  - Concept of Master Data Management  
Section 6Biopharmaceutical - Regulatory and Strategic Management
Lecture 97Introduction : Biopharmaceuticals
Lecture 98Classification of Biopharmaceutical 
Lecture 99Introduction to Biosimilar 
Lecture 100Chemical Drugs Vs. Biologic Drugs
Lecture 101Principle of Naming of Biologics
Lecture 102Current Trends in Biopharmaceutical Market
Lecture 103Global Biologics Market – By Product
Lecture 104Market Share of Different Class of Biopharmaceuticals
Lecture 105Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 106Recombinant protein
Lecture 107Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 108Monoclonal Antibodies
Lecture 109Synthetic Immunomodulators
Lecture 110Production of Monoclonal Antibodies
Lecture 111Cytokines
Lecture 112Interferon
Lecture 113Erythropoiesis-stimulating agent
Lecture 114Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 115Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 116Purple Book: Significance | Searching | Assignments
Lecture 117Biosimilar Development Process
Lecture 118Strategic Consideration for Biosimilar Development 
Lecture 119Bio-Manufacturing Process Information
Lecture 120Studies required for approval of biosimilar
Section 7Drug Registration Dossier
Lecture 121MA Submission Dossier Management
Lecture 122CMC Dossier & Compliance Management
Lecture 123Introduction to Electronic Common Technical Document (ECTD)
Lecture 124Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 125Modules on Stability Study 1
Lecture 126Importance of effective dossier management
Lecture 127Certificate of Analysis
Lecture 128Detailed Understanding on ANDA Submission Dossier 
Lecture 129Prior Approval Submission 
Lecture 130Detailed Understanding on ANDA Fees
Lecture 131Discussion on 85 common deficiency in CTD submission dossier
Lecture 132Key Consideration for Drug Master File Preparation and Submission 
Lecture 133Practical Understanding on Drug Master File Preparation and Submission
Lecture 134Associated Learning: Site Master File - Detailed Understanding 
Lecture 135DMF Completeness Assessment
Lecture 136Drug Master File - Fees
Lecture 137Drug Master File - Global Perspective [Across Different Regions]
Lecture 138Site Master File
Section 8Plant Inspection and Audit Handling
Lecture 139Data Integrity issues in Pharmaceutical Industry
Lecture 140Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 141CAPA
Section 9Introduction to Pharma Brand Manager
Lecture 142Pharma Product Management
Lecture 143Detailed Understanding of Product Management Job
Lecture 144Classification of Doctors
Section 10Marketing Orientation for Business Manager
Lecture 145Marketing Orientation for Product Manager
Lecture 146Why Is Market Research Important in Pharmaceutical Business?
Lecture 147Product Life cycle 
Lecture 148Advance - Strategic Planning in Product Life cycle Management
Lecture 149Segmentation
Lecture 150Pricing
Lecture 151Distribution Channel in Pharmaceutical Industry 
Lecture 152A Pharmaceutical Segmentation outlook
Lecture 153Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 154Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 155Setting and Quantifying Promotional Objectives
Lecture 156Break even analysis
Lecture 157Method of Promotional Budgeting
Lecture 158Basics of Advertising
Lecture 159The Advertising agency
Lecture 160Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 161Advertising Planning - ATL, BTL, TTL activities
Lecture 162Target Audiences for Pharma Promotion : Types and Specialization
Lecture 163Business segments of Pharmaceutical Companies
Lecture 164Target Audience Selection Based on Products
Section 11Practical Training on Pharma Brand Logo Development
Lecture 165Brand Logo - Introduction
Lecture 166Purpose of Brand Logo
Lecture 167Component of Brand Logo
Lecture 168Trademark Registration
Lecture 169Trademark - Practical on TM Search
Lecture 170Trademark Search assignment
Lecture 171How to design excellent brand logo?
Lecture 172How to design excellent brand logo?
Lecture 173Color Systems - RGB & CMYK
Lecture 174Few Case Studies related to brand names and logos
Lecture 175Brand Logo - Simulation
Lecture 176Colour Trademarking in Pharma Branding
Lecture 177How to protect pharma brands globally?
Lecture 178Rebranding in Pharmaceuticals
Lecture 179Brand Logo Development: Real Life Simulation
Lecture 180Brand Tagline - Punchline
Lecture 181Pharma Brand Name Generator
Section 12Advance Pharma Brand Management - 1
Lecture 182Fundamental of Pharma Marketing Plan 
Lecture 183Basic Understanding how to launch a pharmaceutical product into the market 
Lecture 184Practical Training on Marketing Plan Preparation with real life example
Lecture 185Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 186New Product Launch Framework
Lecture 187Sectional Development of Marketing Plan
Lecture 188Decide about brand USP -What to promote 
Lecture 189Sample Marketing Plan
Lecture 190How to prepare promotogram. Download sample Promotogram
Lecture 191Importance and Handling of Cycle Meeting and its importance 
Lecture 192Brand Launch Case Study
Lecture 193Aristada - Launch Case Study
Lecture 194CSR Campaign
Lecture 195Cost Based Working for Sample Allocation
Lecture 196Increase the brand reach with advance segmentation
Lecture 197Concept of uniform branding for better brand acceptability
Lecture 198Concept of Brand Differentiation
Lecture 199Brand Plan to Marketing Campaign - Objective setting to effective execution
Section 13Digital Pharma Marketing
Lecture 200Pharma Packaging Case Studies
Lecture 201Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 202Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 203Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 204Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 205Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 206Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 207Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 208Web Analytics - Tool and Implementation 
Lecture 209Web Host - Check the hosting details 
Lecture 210Page Speed- importance and practical understanding | Check the web speed 
Lecture 211Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 212Mobile Responsive | Tracking the Site 
Lecture 213HCP sites and Patient Site
Lecture 214Google Ad - Practical Training on Campaign Development and Execution
Lecture 215Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 216Brand Portal Development
Lecture 217Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 218Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 219Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 220Difference between FMCG and OTC Brand Ad
Lecture 221Digital Marketing Techniques
Lecture 222Video Marketing
Lecture 223Video Marketing Techniques For Small Business Owners
Lecture 224Promoting Brand through Article Advertising and Marketing
Section 14Analytics
Lecture 225Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 226Compound Annual Growth Rate | CAGR Calculation
Lecture 227Analytical Approach in Determining Brand Potential with case study
Lecture 228Training on Basic Finance  |  Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Section 15Export Documentations
Lecture 229Introduction to Pharmaceutical Export
Lecture 230Introduction of Export Documentation | Understanding of important terminologies
Lecture 231Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 232Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 233Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 234Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 235Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 236Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 237LC Discounting | How it works | How to calculate the LC discounting
Lecture 238Packing List | Importance | Things to include in packing list
Lecture 239Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 240Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 241Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 242Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 243Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 16Project & Portfolio Management
Lecture 244Introduction: Project Management
Lecture 245Difference between Project and Program
Lecture 246Role and Responsibility of Project Leader
Lecture 247Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 248Key to Project Success
Lecture 249Review Test
Lecture 250PERT, CPM, Critical Path, Project Diagram and its components
Lecture 251Project Tracking in Drug Discovery Projects
Lecture 252Project Benchmarking through a Consortium
Lecture 253Cycle Times (Stage or phase lengths)
Lecture 254The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 255What is a milestone chart?
Lecture 256Project Termination and Project Reinitiation
Lecture 257Asset Tracking
Lecture 258Levels of Project and Portfolio Management
Lecture 259Functions of Portfolio Management Team
Lecture 260Importance of Periodic Portfolio Reviews
Lecture 261Portfolio Prioritization
Section 17Business Development Skill Training
Lecture 262Pharma Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 263Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 264Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 265Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 266Numerical SWOT Practical training
Lecture 267Modelling 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 268Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 269Forecasting : Tools and Techniques
Lecture 270Market Sizing & Forecasting Case Study
Lecture 271Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 272Average Royalty Rates
Lecture 273Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 274Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 275Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 276Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 278Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 279Types of Deals from Discovery to Commerialication
Lecture 280Review: What are the fundamental areas of business development
Lecture 281Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 282Licensing Payment Scheduling: Different Types
Lecture 283Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 284Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 285Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 286Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 287Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 288Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 289Due Diligence Activities in Pharmaceutical Licensing
Lecture 290Pharma Business Development - Competency Test. Check your competency
Lecture 291Co-promotion & Co-marketing strategy in pharma industry 
Lecture 292Concept of Reverse co-promotion in pharma industry
Lecture 293Importance of Publications in Pharmaceutical Industry 
Lecture 294Juxtapid Case Study 
Lecture 295New Indication Approval Process and Promotion
Section 18GCC - Pharma Business
Lecture 296GCC Pharma Market
Lecture 297Export to GCC Market
Lecture 298Drug Registration in Saudi Arabia
Lecture 299Drug Registration in UAE
Lecture 300Drug Registration in Kuwait
Lecture 301Drug Registration in Bahrain
Lecture 302Drug Registration in Oman
Lecture 303Documentation Required for the GCC countries 
Lecture 304Comparison of the GCC Registration Requirement with other Regulatory Agencies
Section 19Pharma Business Africa
Lecture 305African Continent Overview
Lecture 306African Pharma Market
Lecture 307Drug Registration - African medicines regulatory
Lecture 308Basic Export Requirement for African Countries
Lecture 309Export Documentations & Important Concepts
Lecture 310Nigeria  - Drug Registration
Lecture 311Drug Registration in Algeria
Lecture 312Drug Registration in Ethiopia
Lecture 313Drug Registration in Kenya
Lecture 314Drug Registration in Egypt
Lecture 315Drug Registration in Ghana
Lecture 316Drug Registration in Botswana
Lecture 317Drug Registration in Uganda
Lecture 318Drug Registration in Sudan
Lecture 319Drug Registration in Morocco
Lecture 320Drug Registration and Regulation in Zimbabwe
Lecture 321Drug Registration and Regulation in Senegal
Lecture 322Drug Registration in Tanzania
Lecture 323Drug Registration in Namibia
Lecture 324Drug Registration in South Africa
Lecture 325Drug Registration in Zambia
Lecture 326Drug Registration in South Africa
Section 20Latam Pharma Market
Lecture 327Introduction to Latam 
Lecture 328Drug Registration and Regulation in Argentina 
Lecture 329Drug Registration and Regulation in Bolivia
Lecture 330Drug Registration and Regulation in Brazil 
Lecture 331Drug Registration and Regulation in CHILE
Lecture 332Drug Registration and Regulation in Colombia
Lecture 333Drug Registration and Regulation in Mexico
Section 21ASEAN Pharma Market - BD & Regulatory Requirements
Lecture 334Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 335The ASEAN Region
Lecture 336ASEAN countries drug regulatory bodies
Lecture 337ACTRs | ACTD requirements | Other Key Factors specific to individual ASEAN countries
Lecture 338The Pharmaceutical Inspection Co-operation Scheme
Lecture 339CPP Requirements for Drug Registration in ASEAN countries
Lecture 340Dossier Requirements - ACTD/CTD Acceptability
Lecture 341Pharmacopoeias Acceptability
Lecture 342Harmonization of Technical Guidelines 
Lecture 343Stability Study requirements for drug registration in ASEAN countries
Lecture 344Product Labelling
Lecture 345Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 346Pharmacovigilance and Risk Management Plan (RMP)
Lecture 347Timeline of Drug Registration Approval
Lecture 348ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 349Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 350Drug Registration and Regulation in Cambodia
Lecture 351Drug Registration and Regulation in Brunei
Section 22Other Country and Business Region
Lecture 352Japan
Lecture 353India
Lecture 354China | ***Updated July 2020 DRR & DMR regulation
Lecture 355Australlia
Lecture 356Russsia