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