Section 1Middle East Pharma Market | Registration | Regulation | Approval Process
Lecture 1Latam Pharma Market
Lecture 2Argentina Pharma Market and Regulation | Pharmaceutical Registration | Strategic PlanningÂ
Lecture 3Brazil Pharma Market | Drug Registration Process | Strategic Planning for Brazil Market
Lecture 4Bolivia Pharma Market and Regulation and Registration | Strategic PlanningÂ
Lecture 5Chile Pharma Market Dynamics | Drug Regulatory System in Chile | Registration of Pharmaceuticals
Lecture 6Colombia Pharma Market | Drug Registration and approval process | Strategic planning for submission managementÂ
Lecture 7Mexico Pharma Market | Regulation | Registration Requirements | Submission Process
Lecture 8Drug regulation and registration in El Salvador
Lecture 9Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Lecture 10Uruguay Pharma Market | Drug Registration and Approval Process | Submission Dossier Requirements
Lecture 11Guatemala Pharma Market
Section 2Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 12Introduction to Pharmaceutical Export
Lecture 13Introduction of Export Documentation | Understanding of important terminologies
Lecture 14Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 15Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 16Commercial Invoice | Importance | Differences with Proforma InvoiceÂ
Lecture 17Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 18Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 19Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 20LC Discounting | How it works | How to calculate the LC discounting
Lecture 21Packing List | Importance | Things to include in packing list
Lecture 22Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 23Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 24Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 25Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 26Certification Pharmaceutical Companies / Plants
Lecture 27Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 28Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planningÂ
Lecture 29WHO-GMP Certification SchemeÂ
Lecture 30Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 31Certificate of Analysis
Lecture 32Certificate of Origin (COO)
Lecture 33Non-conviction certificate
Lecture 34ISO Certification
Lecture 35Common Technical Document (CTD)
Lecture 36Electronic Common Technical Document (ECTD)
Lecture 37Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 38Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 39Importance of effective dossier management
Lecture 40Detailed Understanding on ANDA Submission DossierÂ
Lecture 41Prior Approval SubmissionÂ
Lecture 42Detailed Understanding on ANDA Fees
Lecture 43Discussion on 85 common deficiency in CTD submission dossier
Lecture 44Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planningÂ
Lecture 45WHO-GMP Certification SchemeÂ
Lecture 46Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 3Pharma R&D Fundamental | Patent | Exclusivity | Portfolio Management |Strategic Pathways
Lecture 47R&D Process & Introduction to drug discovery
Lecture 48Investigational New Drug Application (INDA)
Lecture 49New Drug Application (NDA)Â
Lecture 50Basic concept and understanding of the Generic Drug
Lecture 51Abbreviated New Drug Application (ANDA)Â
Lecture 52Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 53Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 54Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 55Orphan Drug DesignationÂ
Lecture 56Handling of orange book
Lecture 57Purple Book: Significance | Searching | Assignments
Lecture 58USFDAÂ expedited programs
Lecture 59Authorized Generics: Key Understanding
Lecture 60Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 61Clinical Trial Protocol Writing
Lecture 62Ethics in Clinical Research
Lecture 63Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 64Strategic Planning in different phases of Clinical Trial
Lecture 65Para IV Filing
Lecture 66Para IV Notices
Lecture 67Evergreening - Patent Life Extension Strategies
Lecture 68Pay For Delay Strategy
Lecture 69REMS Strategic PlanningÂ
Lecture 70Compulsory Licensing
Lecture 71Licensing & Technology Transfer
Lecture 72In-Licensing Vs. Outlicensing
Lecture 73LOE Strategies for Innovator Brands with case study
Lecture 74Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 75Drug Repurposing
Lecture 76Advance understanding of the portfolio ManagementÂ
Lecture 77New Indication Approval Process and PromotionÂ
Lecture 78OTC SwitchÂ
Lecture 79Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 80What is meaning of 'Pipeline in a Molecule'?
Lecture 81Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Lecture 82Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 83Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 84Review on Drug Discovery and DevelopmentÂ
Section 4Pharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 85Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 86Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 87Market Access Strategic Planning
Lecture 88Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 89Indication Prioritization Case Study
Lecture 90Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 91AMCP Market Access Value Dossier Preparation
Lecture 92Drug Pricing Methodologies
Lecture 93Sales Forecasting in Life Science Industry
Lecture 94New Product Forecast Algorithm
Lecture 95Patient Based Forecasting Model | Applying more filters and variables
Lecture 96Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 97Prevalence Vs. Incidence Model
Lecture 98EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 99Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 100Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 101Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 102Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 103Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 104Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 105Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 106Simulation on Bottom-up forecasting
Lecture 107Assessment on Bottom-up forecasting
Lecture 108Oncology Brand Forecasting
Lecture 109Revenue Forecasting Case Study - Novel AntihypertensiveÂ
Lecture 110Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Lecture 111QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 112ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Section 5Pharma Brand Management | Key Branding Training for Pharma Business Development Professionals
Lecture 113Marketing Orientation
Lecture 114Why Is Market Research Important in Pharmaceutical Business?
Lecture 115Market Research - Customer Engagement through feedback mechanismÂ
Lecture 116Product Life cycleÂ
Lecture 117Advance - Strategic Planning in Product Life cycle Management
Lecture 118Segmentation, Targeting and Positioning
Lecture 119Pricing
Lecture 120A Pharmaceutical Segmentation outlook
Lecture 121Distribution Channel in Pharmaceutical IndustryÂ
Lecture 122Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 123Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 124Method of Promotional Budgeting
Lecture 125Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 126Advertising - Introduction | Objective | Types of AdvertisingÂ
Lecture 127ATL, BTL & TTL Advertising
Lecture 128Advertising Agency - Understanding on various types of advertising agency
Lecture 129Selection of Advertising Agency
Lecture 130What is creative Briefing? How to Prepare !
Lecture 131Creative Briefing - Practical Simulation
Lecture 132Request for Proposal | Concepts in advertising
Lecture 133Advertising Message Strategy Development and Evaluation
Lecture 134Creative Approach and Styles
Lecture 135Steps of Development of Creatives
Lecture 136Advertisement Copy Development
Lecture 137How to prepare Ad Campaign Step By Step
Lecture 138Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 139Advance Understanding of Pharmaceutical Brand Logo DevelopmentÂ
Lecture 140Component of Brand Logo
Lecture 141Brand Name and Trademark Registration Process
Lecture 142Trademark Searching Process | Hands on Practical Training
Lecture 143How to design an excellent brand logo : Tricks of the trade
Lecture 144Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 145Few Case Studies related to brand names and logos
Lecture 146Can one innovator company keep 2 or more brand name?
Lecture 147Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma BrandingÂ
Lecture 148Global Trademarking : Brand Protection GloballyÂ
Lecture 149Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced RebrandingÂ
Lecture 150Brand Logo Development: Real Life Simulation
Lecture 151Tagline - Development, Finalization and Protection
Lecture 152Pharma Brand Name Generator
Lecture 153Fundamental of Pharma Marketing PlanÂ
Lecture 154Basic Understanding how to launch a pharmaceutical product into the market
Lecture 155Practical Training on Marketing Plan Preparation with real life example
Lecture 156Marketing Campaign Development : Importance of Target Audience Segmentation for effective targetingÂ
Lecture 157Sample Marketing PlanÂ
Lecture 158Decide about brand USP -What to promoteÂ
Lecture 159How to prepare promotogram. Download sample Promotogram
Lecture 160Importance and Handling of Cycle Meeting and its importanceÂ
Lecture 161Sample Marketing Plan
Lecture 162Sample Marketing Plan
Lecture 163Sample Marketing Plan
Lecture 164CSR CampaignÂ
Lecture 165Increase the brand reach with advance segmentation
Lecture 166Concept of uniform branding for better brand acceptability
Lecture 167Concept of Brand Differentiation
Lecture 168Introduction to visual aid designing | V3M Concept | Components of the visual aid page
Lecture 169Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aidÂ
Lecture 170Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendorsÂ
Lecture 171Visual Aid Analysis with practical example
Lecture 172Guideline on visual aid development
Lecture 173Marketing Plan followed by Visual Aid Development
Lecture 174Visual Aid, Literature reference Sample
Lecture 175Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aidsÂ
Lecture 176Visual aid detailing story writing
Lecture 177Artwork Development Process in PMT Department
Lecture 178Product List and Reminder card development
Lecture 179Catch Cover Development
Lecture 180Packaging DevelopmentÂ
Lecture 181Prescribing Information and Patient Information Leaflet development
Lecture 182Pharma Packaging Case Studies
Lecture 183DHCP letter
Lecture 184Product Packshot Designing : Practical Knowledge
Lecture 185Creativity to develop brand essence
Lecture 186Advance Training on Pharmaceutical Packaging -Â Creative Packaging for Brand DifferentiationÂ
Lecture 187Unique identifier & anti-tampering device on outer packaging
Section 6Business Development | Licensing
Lecture 188Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 189Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 190Compound Annual Growth Rate | CAGR Calculation
Lecture 191Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 192Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 193Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 194Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 195Numerical SWOT Practical training
Lecture 196Modelling 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 197Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 198Forecasting : Tools and Techniques
Lecture 199Market Sizing & Forecasting Case Study
Lecture 200Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 201Average Royalty Rate
Lecture 202Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 203Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 204Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 205Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 206SPECIAL PURPOSE VEHICLES (SPV)
Lecture 207Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 208Types of Deals from Discovery to Commercialization
Lecture 209What are the fundamental areas of business development
Lecture 210Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 211Licensing Payment Scheduling: Different Types
Lecture 212Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 213Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 214Negotiation 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 215Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 216Types 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 firmsÂ
Lecture 217Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Section 7Pharma Digital Marketing
Lecture 218Introduction to Digital MarketingÂ
Lecture 219Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 220Digital 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 221Digital 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 222Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 223Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 224Campaign 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 225Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 226Web Host - Check the hosting detailsÂ
Lecture 227Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 228Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 229Mobile Responsive | Tracking the SiteÂ
Lecture 230HCP sites and Patient Site
Lecture 231Google Ad - Practical Training on Campaign Development and Execution
Lecture 232Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 233Brand Portal Development
Lecture 234Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 235Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 236Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 237Difference between FMCG and OTC Brand Ad
Lecture 238Digital Marketing Techniques
Lecture 239Video Marketing
Lecture 240Video Marketing Techniques For Small Business Owners
Lecture 241Promoting Brand through Article Advertising and Marketing