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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

  • Self paced learning – 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, case studies, simulations.
  • Attend Lectures of all different chapters / study content.

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 mentioned is mandatory for admission into this course. Work Experience certificate / proof need to be provided at the time of admission.

FAQ RELATED TO THE COURSE

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ADMISSION PROCESS

  • 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.

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 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 31IPR - Patent Grant and Handling Process in India
Lecture 32Trademark Searching Process | Hands on Practical Training
Lecture 33Trademark Search assignment (India)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Lecture 35Patent Cliff
Lecture 36Patent Infringement | Types of Patent Infringements | Step By Step handling of patent infringement cases | Injunctions | Restraining Order
Section 3Global Strategic Management
Lecture 37Understanding of Regulatory Strategies
Lecture 38Advance study on Para IV Filing
Lecture 39Para IV Notices
Lecture 40Evergreening - Patent Life Extension Strategies
Lecture 41Pay For Delay Strategy
Lecture 42REMS Strategic Planning 
Lecture 43Compulsory Licensing
Lecture 44Licensing & Technology Transfer
Lecture 45In-Licensing Vs. Outlicensing
Lecture 46LOE Strategies for Innovator Brands with case study
Lecture 47Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 48Drug Repurposing
Lecture 49Licensing - Advance Learning 
Lecture 50Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 51NCE Vs. 505b2 application - Case Based Learning 
Lecture 52FTF - 180 Days Exclusivity - Case Based Learning
Lecture 53Classic case study of the 505b2 filing : Case Based Learning
Lecture 54Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 55Pipeline in a Molecule
Lecture 56Emergency Use Authorization (EUA)
Section 4Basic Fundamental of Pharma Production & Plant Management
Lecture 57Definition of GMP
Lecture 58Premises & Plant Layout Designing
Lecture 59Sanitation and Hygiene
Lecture 60Equipment Modules
Lecture 61Production Modules
Lecture 62Documentation
Lecture 63Quality Control
Lecture 64G7 Lecture Product Complaint
Lecture 65G8 Lecture Storage Module
Lecture 66ISO and ISO Audits
Lecture 67CAPA
Section 5Global Business : European Union - Regulatory & Strategic Planning
Lecture 68Introduction to EU Regulation 
Lecture 69Orientation to European Countries and National Regulatory Bodies
Lecture 70Orientation to European Countries and National Regulatory Bodies
Lecture 71Overview of EU Regulation
Lecture 72EMA and EMA Authorisation Process
Lecture 73Summary of Product Characteristics
Lecture 74Compassionate Use
Lecture 75EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 76Validity 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 77Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 78EU Orphan Medicinal Products Regulation
Lecture 79Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 80Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 81Summary of Product Characteristics 
Lecture 82Compassionate Use
Lecture 83MHRA - UK Regulation 
Lecture 84The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 85EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 86EU Prime Designation 
Lecture 87Accelerated assessment by EMEA
Lecture 88EU Adaptive Pathway
Lecture 89European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 90SPOR  - Concept of Master Data Management  
Section 6Biopharmaceutical - Regulatory and Strategic Management
Lecture 91Introduction : Biopharmaceuticals
Lecture 92Classification of Biopharmaceutical 
Lecture 93Introduction to Biosimilar 
Lecture 94Chemical Drugs Vs. Biologic Drugs
Lecture 95Principle of Naming of Biologics
Lecture 96Current Trends in Biopharmaceutical Market
Lecture 97Global Biologics Market – By Product
Lecture 98Market Share of Different Class of Biopharmaceuticals
Lecture 99Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 100Market Understanding: Leading Biosimilar Companies
Lecture 101Market Understanding: Top Leading Brands
Lecture 102Recombinant protein
Lecture 103Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 104Monoclonal Antibodies
Lecture 105Synthetic Immunomodulators
Lecture 106Production of Monoclonal Antibodies
Lecture 107Cytokines
Lecture 108Interferon
Lecture 109Erythropoiesis-stimulating agent
Lecture 110Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 111Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 112Purple Book: Significance | Searching | Assignments
Lecture 113Biosimilar Development Process
Lecture 114Strategic Consideration for Biosimilar Development 
Lecture 115Bio-Manufacturing Process Information
Lecture 116Studies required for approval of biosimilar
Section 7Drug Registration Dossier
Lecture 117MA Submission Dossier Management
Lecture 118CMC Dossier & Compliance Management
Lecture 119Introduction to Electronic Common Technical Document (ECTD)
Lecture 120Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 121Modules on Stability Study 1
Lecture 122Importance of effective dossier management
Lecture 123Certificate of Analysis
Lecture 124Detailed Understanding on ANDA Submission Dossier 
Lecture 125Prior Approval Submission 
Lecture 126Detailed Understanding on ANDA Fees
Lecture 127Discussion on 85 common deficiency in CTD submission dossier
Lecture 128Key Consideration for Drug Master File Preparation and Submission 
Lecture 129Practical Understanding on Drug Master File Preparation and Submission
Lecture 130Associated Learning: Site Master File - Detailed Understanding 
Lecture 131DMF Completeness Assessment
Lecture 132Drug Master File - Fees
Lecture 133Drug Master File - Global Perspective [Across Different Regions]
Lecture 134Site Master File
Section 8Plant Inspection and Audit Handling
Lecture 135Data Integrity issues in Pharmaceutical Industry
Lecture 136Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 137CAPA
Section 9Introduction to Pharma Brand Manager
Lecture 138Pharma Product Management
Lecture 139Detailed Understanding of Product Management Job
Lecture 140Classification of Doctors
Section 10Marketing Orientation for Business Manager
Lecture 141Marketing Orientation for Product Manager
Lecture 142Why Is Market Research Important in Pharmaceutical Business?
Lecture 143Product Life cycle 
Lecture 144Advance - Strategic Planning in Product Life cycle Management
Lecture 145Segmentation
Lecture 146Pricing
Lecture 147Distribution Channel in Pharmaceutical Industry 
Lecture 148A Pharmaceutical Segmentation outlook
Lecture 149Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 150Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 151Setting and Quantifying Promotional Objectives
Lecture 152Break even analysis
Lecture 153Method of Promotional Budgeting
Lecture 154Basics of Advertising
Lecture 155The Advertising agency
Lecture 156Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 157Advertising Planning - ATL, BTL, TTL activities
Lecture 158Target Audiences for Pharma Promotion : Types and Specialization
Lecture 159Business segments of Pharmaceutical Companies
Lecture 160Target Audience Selection Based on Products
Section 11Practical Training on Pharma Brand Logo Development
Lecture 161Brand Logo - Introduction
Lecture 162Purpose of Brand Logo
Lecture 163Component of Brand Logo
Lecture 164Trademark Registration
Lecture 165Trademark - Practical on TM Search
Lecture 166Trademark Search assignment
Lecture 167How to design excellent brand logo?
Lecture 168How to design excellent brand logo?
Lecture 169Color Systems - RGB & CMYK
Lecture 170Few Case Studies related to brand names and logos
Lecture 171Brand Logo - Simulation
Lecture 172Colour Trademarking in Pharma Branding
Lecture 173How to protect pharma brands globally?
Lecture 174Rebranding in Pharmaceuticals
Lecture 175Brand Logo Development: Real Life Simulation
Lecture 176Brand Tagline - Punchline
Lecture 177Pharma Brand Name Generator
Section 12Advance Pharma Brand Management - 1
Lecture 178Fundamental of Pharma Marketing Plan 
Lecture 179Basic Understanding how to launch a pharmaceutical product into the market 
Lecture 180Practical Training on Marketing Plan Preparation with real life example
Lecture 181Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 182New Product Launch Framework
Lecture 183Sectional Development of Marketing Plan
Lecture 184Decide about brand USP -What to promote 
Lecture 185Sample Marketing Plan
Lecture 186How to prepare promotogram. Download sample Promotogram
Lecture 187Importance and Handling of Cycle Meeting and its importance 
Lecture 188Brand Launch Case Study
Lecture 189Aristada - Launch Case Study
Lecture 190CSR Campaign
Lecture 191Cost Based Working for Sample Allocation
Lecture 192Increase the brand reach with advance segmentation
Lecture 193Concept of uniform branding for better brand acceptability
Lecture 194Concept of Brand Differentiation
Lecture 195Brand Plan to Marketing Campaign - Objective setting to effective execution
Section 13Digital Pharma Marketing
Lecture 196Pharma Packaging Case Studies
Lecture 197Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 198Digital 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 199Digital 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 200Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 201Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 202Campaign 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 203Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 204Web Analytics - Tool and Implementation 
Lecture 205Web Host - Check the hosting details 
Lecture 206Page Speed- importance and practical understanding | Check the web speed 
Lecture 207Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 208Mobile Responsive | Tracking the Site 
Lecture 209HCP sites and Patient Site
Lecture 210Google Ad - Practical Training on Campaign Development and Execution
Lecture 211Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 212Brand Portal Development
Lecture 213Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 214Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 215Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 216Difference between FMCG and OTC Brand Ad
Lecture 217Digital Marketing Techniques
Lecture 218Video Marketing
Lecture 219Video Marketing Techniques For Small Business Owners
Lecture 220Promoting Brand through Article Advertising and Marketing
Section 14Analytics
Lecture 221Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 222Compound Annual Growth Rate | CAGR Calculation
Lecture 223Analytical Approach in Determining Brand Potential with case study
Section 15Fundamental understanding in Finance
Section 16Project & Portfolio Management
Lecture 225Introduction: Project Management
Lecture 226Difference between Project and Program
Lecture 227Role and Responsibility of Project Leader
Lecture 228Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 229Key to Project Success
Lecture 230Review Test
Lecture 231PERT, CPM, Critical Path, Project Diagram and its components
Lecture 232Project Tracking in Drug Discovery Projects
Lecture 233Project Benchmarking through a Consortium
Lecture 234Cycle Times (Stage or phase lengths)
Lecture 235The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 236What is a milestone chart?
Lecture 237Project Termination and Project Reinitiation
Lecture 238Asset Tracking
Lecture 239Levels of Project and Portfolio Management
Lecture 240Functions of Portfolio Management Team
Lecture 241Importance of Periodic Portfolio Reviews
Lecture 242Portfolio Prioritization
Section 17Business Development Skill Training
Lecture 243Pharma Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 244Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 245Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 246Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 247Numerical SWOT Practical training
Lecture 248Modelling 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 249Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 250Forecasting : Tools and Techniques
Lecture 251Market Sizing & Forecasting Case Study
Lecture 252Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 253Average Royalty Rates
Lecture 254Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 255Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 256Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 257Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 258SPECIAL PURPOSE VEHICLES (SPV)
Lecture 259Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 260Types of Deals from Discovery to Commerialication
Lecture 261Review: What are the fundamental areas of business development
Lecture 262Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 263Licensing Payment Scheduling: Different Types
Lecture 264Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 265Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 266Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 267Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 268Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 269Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 270Due Diligence Activities in Pharmaceutical Licensing
Lecture 271Pharma Business Development - Competency Test. Check your competency
Lecture 272Co-promotion & Co-marketing strategy in pharma industry 
Lecture 273Concept of Reverse co-promotion in pharma industry
Lecture 274Importance of Publications in Pharmaceutical Industry 
Lecture 275Juxtapid Case Study 
Lecture 276New Indication Approval Process and Promotion
Section 18GCC - Pharma Business
Lecture 277GCC Pharma Market
Lecture 278Export to GCC Market
Lecture 279Drug Registration in Saudi Arabia
Lecture 280Drug Registration in UAE
Lecture 281Drug Registration in Kuwait
Lecture 282Drug Registration in Bahrain
Lecture 283Drug Registration in Oman
Lecture 284Documentation Required for the GCC countries 
Lecture 285Comparison of the GCC Registration Requirement with other Regulatory Agencies
Section 19Pharma Business Africa
Lecture 286African Continent Overview
Lecture 287African Pharma Market
Lecture 288Drug Registration - African medicines regulatory
Lecture 289Basic Export Requirement for African Countries
Lecture 290Export Documentations & Important Concepts
Lecture 291Nigeria  - Drug Registration
Lecture 292Drug Registration in Algeria
Lecture 293Drug Registration in Ethiopia
Lecture 294Drug Registration in Kenya
Lecture 295Drug Registration in Egypt
Lecture 296Drug Registration in Ghana
Lecture 297Drug Registration in Botswana
Lecture 298Drug Registration in Uganda
Lecture 299Drug Registration in Sudan
Lecture 300Drug Registration in Morocco
Lecture 301Drug Registration and Regulation in Zimbabwe
Lecture 302Drug Registration and Regulation in Senegal
Lecture 303Drug Registration in Tanzania
Lecture 304Drug Registration in Namibia
Lecture 305Drug Registration in South Africa
Lecture 306Drug Registration in Zambia
Lecture 307Drug Registration in South Africa
Section 20Latam Pharma Market
Lecture 308Introduction to Latam 
Lecture 309Drug Registration and Regulation in Argentina 
Lecture 310Drug Registration and Regulation in Bolivia
Lecture 311Drug Registration and Regulation in Brazil 
Lecture 312Drug Registration and Regulation in CHILE
Lecture 313Drug Registration and Regulation in Colombia
Lecture 314Drug Registration and Regulation in Mexico
Section 21ASEAN Pharma Market - BD & Regulatory Requirements
Lecture 315Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 316The ASEAN Region
Lecture 317ASEAN countries drug regulatory bodies
Lecture 318ACTRs | ACTD requirements | Other Key Factors specific to individual ASEAN countries
Lecture 319The Pharmaceutical Inspection Co-operation Scheme
Lecture 320CPP Requirements for Drug Registration in ASEAN countries
Lecture 321Dossier Requirements - ACTD/CTD Acceptability
Lecture 322Pharmacopoeias Acceptability
Lecture 323Harmonization of Technical Guidelines 
Lecture 324Stability Study requirements for drug registration in ASEAN countries
Lecture 325Product Labelling
Lecture 326Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 327Pharmacovigilance and Risk Management Plan (RMP)
Lecture 328Timeline of Drug Registration Approval
Section 22Other Country and Business Region
Lecture 329Japan
Lecture 330India
Lecture 331China | ***Updated July 2020 DRR & DMR regulation
Lecture 332Australlia
Lecture 333Russsia