Section 1Middle East Pharma Market | Registration | Regulation | Approval Process
Lecture 1Middle East / MENA / GCC Countries Geographical Orientation
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 Market | Registration and Regulation
Lecture 15Introduction to UAE Healthcare System | Structure | Funding | Insurance | Initiative and Policies | Roles of UAE Regulatory Bodies
Lecture 16Drug Registration in UAE | Classification | Pathway | Registration Process | Timeline | Variation Filing
Lecture 17Documentation and Registration of Drug Registration in UAE | Checklist Preparation Development
Lecture 18UAE Data Exclusivity | Scenario based exclusivity periods | UAE Vs. EU Data Exclusivity | UAE Vs. Saudi Arabia Data Exclusivity
Lecture 19UAE Pharmaceutical and Biopharmaceutical Market Access | Case Study | Case Based Assessment
Lecture 20Timeline of Drug Approval (UAE) | Case Assignment
Section 2Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 21Introduction to Pharmaceutical Export
Lecture 22Introduction of Export Documentation | Understanding of important terminologies
Lecture 23Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 24Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 25Commercial Invoice | Importance | Differences with Proforma Invoice
Lecture 26Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 27Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 28Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 29LC Discounting | How it works | How to calculate the LC discounting
Lecture 30Packing List | Importance | Things to include in packing list
Lecture 31Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 32Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 33Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 34Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 35Certification Pharmaceutical Companies / Plants
Lecture 36Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 37Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning
Lecture 38WHO-GMP Certification Scheme
Lecture 39Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 40Certificate of Analysis
Lecture 41Certificate of Origin (COO)
Lecture 42Non-conviction certificate
Lecture 43ISO Certification
Lecture 44Common Technical Document (CTD)
Lecture 45Electronic Common Technical Document (ECTD)
Lecture 46Dossier Preparation focusing on drug registration in export countries
Lecture 47Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 48Importance of effective dossier management
Lecture 49Detailed Understanding on ANDA Submission Dossier
Lecture 50Prior Approval Submission
Lecture 51Detailed Understanding on ANDA Fees
Lecture 52Discussion on 85 common deficiency in CTD submission dossier
Lecture 53Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning
Lecture 54WHO-GMP Certification Scheme
Lecture 55Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 56Difference between Proforma and Quotation
Lecture 57Bank Guarantee Cycle with Example
Lecture 58CHA and IFF Requirements - Roles and Conditions
Lecture 59Incoterm Understanding with case study
Section 3Pharma R&D Fundamental | Patent | Exclusivity | Portfolio Management |Strategic Pathways
Lecture 60R&D Process & Introduction to drug discovery
Lecture 61Investigational New Drug Application (INDA)
Lecture 62New Drug Application (NDA)
Lecture 63Basic concept and understanding of the Generic Drug
Lecture 64Abbreviated New Drug Application (ANDA)
Lecture 65Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 66Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 67Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 68Orphan Drug Designation
Lecture 69Handling of orange book
Lecture 70Purple Book: Significance | Searching | Assignments
Lecture 71USFDA expedited programs
Lecture 72Authorized Generics: Key Understanding
Lecture 73Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 74Clinical Trial Protocol Writing
Lecture 75Ethics in Clinical Research
Lecture 76Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 77Strategic Planning in different phases of Clinical Trial
Lecture 78Para IV Filing
Lecture 79Para IV Notices
Lecture 80Evergreening - Patent Life Extension Strategies
Lecture 81Pay For Delay Strategy
Lecture 82REMS Strategic Planning
Lecture 83Compulsory Licensing
Lecture 84Licensing & Technology Transfer
Lecture 85In-Licensing Vs. Outlicensing
Lecture 86LOE Strategies for Innovator Brands with case study
Lecture 87Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 88Drug Repurposing
Lecture 89Advance understanding of the portfolio Management
Lecture 90New Indication Approval Process and Promotion
Lecture 91OTC Switch
Lecture 92Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 93What is meaning of 'Pipeline in a Molecule'?
Lecture 94Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Lecture 95Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 96Fundamental 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 97Review on Drug Discovery and Development
Section 4Pharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 98Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 99Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 100Market Access Strategic Planning
Lecture 101Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 102Indication Prioritization Case Study
Lecture 103Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 104AMCP Market Access Value Dossier Preparation
Lecture 105Drug Pricing Methodologies
Lecture 106Sales Forecasting in Life Science Industry
Lecture 107New Product Forecast Algorithm
Lecture 108Patient Based Forecasting Model | Applying more filters and variables
Lecture 109Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 110Prevalence Vs. Incidence Model
Lecture 111EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 112Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 113Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 114Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 115Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 116Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 117Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 118Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 119Simulation on Bottom-up forecasting
Lecture 120Assessment on Bottom-up forecasting
Lecture 121Oncology Brand Forecasting
Lecture 122Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 123Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 124QALY | How to calculate QALY | Importance and Significance
Lecture 125ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Section 5Pharma Brand Management | Key Branding Training for Pharma Business Development Professionals
Lecture 126Marketing Orientation
Lecture 127Why Is Market Research Important in Pharmaceutical Business?
Lecture 128Market Research - Customer Engagement through feedback mechanism
Lecture 129Product Life cycle
Lecture 130Advance - Strategic Planning in Product Life cycle Management
Lecture 131Segmentation, Targeting and Positioning
Lecture 132Pricing
Lecture 133A Pharmaceutical Segmentation outlook
Lecture 134Distribution Channel in Pharmaceutical Industry
Lecture 135Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 136Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 137Method of Promotional Budgeting
Lecture 138Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 139Advertising - Introduction | Objective | Types of Advertising
Lecture 140ATL, BTL & TTL Advertising
Lecture 141Advertising Agency - Understanding on various types of advertising agency
Lecture 142Selection of Advertising Agency
Lecture 143What is creative Briefing? How to Prepare !
Lecture 144Creative Briefing - Practical Simulation
Lecture 145Request for Proposal | Concepts in advertising
Lecture 146Advertising Message Strategy Development and Evaluation
Lecture 147Creative Approach and Styles
Lecture 148Steps of Development of Creatives
Lecture 149Advertisement Copy Development
Lecture 150How to prepare Ad Campaign Step By Step
Lecture 151Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 152Advance Understanding of Pharmaceutical Brand Logo Development
Lecture 153Trademark Searching Process | Hands on Practical Training
Lecture 154How to design an excellent brand logo : Tricks of the trade
Lecture 155Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 156Few Case Studies related to brand names and logos
Lecture 157Can one innovator company keep 2 or more brand name?
Lecture 158Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding
Lecture 159Global Trademarking : Brand Protection Globally
Lecture 160Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding
Lecture 161Brand Logo Development: Real Life Simulation
Lecture 162Tagline - Development, Finalization and Protection
Lecture 163Pharma Brand Name Generator
Lecture 164Fundamental of Pharma Marketing Plan
Lecture 165Basic Understanding how to launch a pharmaceutical product into the market
Lecture 166Practical Training on Marketing Plan Preparation with real life example
Lecture 167Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting
Lecture 168Sample Marketing Plan
Lecture 169Decide about brand USP -What to promote
Lecture 170How to prepare promotogram. Download sample Promotogram
Lecture 171Importance and Handling of Cycle Meeting and its importance
Lecture 172Sample Marketing Plan
Lecture 173Sample Marketing Plan
Lecture 174Sample Marketing Plan
Lecture 175CSR Campaign
Lecture 176Increase the brand reach with advance segmentation
Lecture 177Concept of uniform branding for better brand acceptability
Lecture 178Concept of Brand Differentiation
Lecture 179Introduction to visual aid designing | V3M Concept | Components of the visual aid page
Lecture 180Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid
Lecture 181Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors
Lecture 182Visual Aid Analysis with practical example
Lecture 183Guideline on visual aid development
Lecture 184Marketing Plan followed by Visual Aid Development
Lecture 185Visual Aid, Literature reference Sample
Lecture 186Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids
Lecture 187Visual aid detailing story writing
Lecture 188Artwork Development Process in PMT Department
Lecture 189Product List and Reminder card development
Lecture 190Catch Cover Development
Lecture 191Packaging Development
Lecture 192Prescribing Information and Patient Information Leaflet development
Lecture 193Product Packshot Designing : Practical Knowledge
Lecture 194Creativity to develop brand essence
Lecture 195Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation
Section 6Business Development | Licensing
Lecture 196Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 197Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 198Compound Annual Growth Rate | CAGR Calculation
Lecture 199Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 200Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 201Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 202Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 203Numerical SWOT Practical training
Lecture 204Modelling 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 205Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 206Forecasting : Tools and Techniques
Lecture 207Market Sizing & Forecasting Case Study
Lecture 208Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 209Average Royalty Rate
Lecture 210Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 211Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 212Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 213SPECIAL PURPOSE VEHICLES (SPV)
Lecture 214Indication Splitting | Concept | Implementation feasibility analysis
Lecture 215Types of Deals from Discovery to Commercialization
Lecture 216What are the fundamental areas of business development
Lecture 217Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 218Licensing Payment Scheduling: Different Types
Lecture 219Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 220Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 221Negotiation 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 222Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 223Types 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 firms
Lecture 224Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Lecture 225Value Share Principle | Discounting of licensing deal | Discount Rate
Lecture 226DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 227Net Present Value (NPV) method : Calculation
Lecture 228Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium
Lecture 229Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 230Comparable Company Analysis method : Calculation
Section 7Pharma Digital Marketing
Lecture 231Introduction to Digital Marketing
Lecture 232Inbound and outbound marketing in pharma | Types of inbound and outbound marketing
Lecture 233Digital 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 234Digital 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 235Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 236Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 237Campaign 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 238Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 239Web Host - Check the hosting details
Lecture 240Page Speed- importance and practical understanding | Check the web speed
Lecture 241Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 242Mobile Responsive | Tracking the Site
Lecture 243HCP sites and Patient Site
Lecture 244Google Ad - Practical Training on Campaign Development and Execution
Lecture 245Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 246Brand Portal Development
Lecture 247Relationship Marketing : KOL Management and Patient Advocacy Group
Lecture 248Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 249Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 250Difference between FMCG and OTC Brand Ad
Lecture 251Digital Marketing Techniques
Lecture 252Video Marketing
Lecture 253Video Marketing Techniques For Small Business Owners
Lecture 254Promoting Brand through Article Advertising and Marketing