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TypeOnline Course
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Price$930 / 46500 INR.
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pharma global management

Introduction

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About Pharma Management

pharma global management

Pharma global management course provides hands on training to enhance skill competency of pharmaceutical middle and top level managers. This course ideal for the working professionals of pharmaceutical and biopharmaceutical industry. This comprehensive pharma global management training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses on how pharma business development, strategic management, regulatory and licensing professionals working in the company. Therefore, it helps advance professionals to acquire cutting edged business skills. 

In these online self-paced modules, participants understands about the development to commercialization process in detail. In other words, you will understand portfolio strategic management. Hence, the course covers fundamentals to advance learning on various skill areas. 

Who should attend this course? 

  • Those who are in the regulatory affairs and related department.
  • Professionals from strategic management. 
  • Those who are in business development and licensing department.
  • This pharma global management course is ideal for the senior management professionals working in pharmaceutical and biopharmaceutical project management.
  • Anyone requiring an overview and detail understanding on working of pharmaceutical management. 
  • Fresher or beginners, Those who want to make a career in the management in pharmaceutical and biopharmaceutical company. 

Key details about the course:

  • Course Code: RYD-080
  • Title: Executive PG Certification in Pharma Global Management (EPPGM)
  • Type of the course: Self paced Online Course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
  • Duration of the course: 1 Year. Course can completed within 1 year based on own speed of access.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course

Any body who wants to acquire pharma strategic management competency should attend the course.

Features of Pharma Global Management Course

  • This pharma global management covers all aspects of the strategic management from drug discovery development, regulatory, commercialization, marketing, branding, business development and sales.
  • The course provides orientation to job related practical aspects of the business development managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Business Development Professional works.
  • One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the licensing and  decision making skills which is the core aspects of the pharmaceutical management working.

Case Based Learning

  • Advance training on strategic management based on the various business regions.
  • Course covers regional business development requirements specific to US, EU, Middle East, GCC, MENA, African, ASEAN, Latam, China, Japan, India etc.
  • Access to Case Studies to learn about the drug commercialization steps. Hence, participants will develop advanced competency on strategic portfolio management.

Career in pharma global management

A career in pharma management is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for trained professionals. Companies always look for the trained professionals with relevant experience for the pharma management department. This is because, the strategic management job covers a variety of disciplines. Hence, pharma management professional involved in drug development, discovery, regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance, branding, business development and licensing. So, person who want to be successful in pharma management should have 360 degree knowledge in various domain of pharma business.

Knowledge of the various business regions is important

The pharmaceutical industry is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Hence, the major objective of the pharma management professionals to learn various regional regulatory knowledge. In fact, regional regulatory knowledge will help them to become successful in international business management. Moreover, pharma regulations are evolving and changing every other day. Pharma Management Professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. Therefore, this course is ideal choice for the pharma management course which covers various domain.

About regulatory affairs job>> Learn here

Section 1Pharma R&D Management- Discovery to Development | Strategic Management for US Market
Lecture 1R&D Process & Introduction to drug discovery
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) 
Lecture 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Purple Book: Significance | Searching | Assignments
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 16Orphan Drug Designation 
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls 
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Importance and Significance of Phase 2b Clinical Trial 
Lecture 27Regulatory Strategies in different phases of Clinical Trial
Lecture 28Para IV Filing - Strategic Insight
Lecture 29Para IV Notices
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31Pay For Delay Strategy
Lecture 32REMS Strategic Planning 
Lecture 33Compulsory Licensing
Lecture 34Licensing & Technology Transfer
Lecture 35In-Licensing Vs. Outlicensing
Lecture 36LOE Strategies for Innovator Brands with case study
Lecture 37Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 38Drug Repurposing
Lecture 39Advance understanding of the portfolio Management 
Lecture 40New Indication Approval Process and Promotion 
Lecture 41OTC Switch 
Lecture 42Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 43NCE Vs. 505b2 application - Case Based Learning 
Lecture 44FTF - 180 Days Exclusivity - Case Based Learning
Lecture 45Classic case study of the 505b2 filing : Case Based Learning
Lecture 46Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 47What is meaning of 'Pipeline in a Molecule'?
Lecture 48USFDA Emergency Use Authorization (EUA)
Lecture 49Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 50Fundamental 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 51Review on Drug Discovery and Development 
Section 2Strategic Business Management - European Market
Lecture 52Introduction to EU Regulation 
Lecture 53Orientation to European Countries and National Regulatory Bodies
Lecture 54EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 55Overview of EU Regulation 
Lecture 56EMA and EMA Authorisation Process
Lecture 57EU MA Application Types and Strategic Planning
Lecture 58EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 59EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 60Validity 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 61Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 62EU Orphan Medicinal Products Regulation
Lecture 63Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 64Summary of Product Characteristics 
Lecture 65Compassionate Use
Lecture 66MHRA - UK Regulation 
Lecture 67The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 68Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 69EU Prime Designation
Lecture 70Accelerated assessment by EMEA
Lecture 71EU Adaptive Pathway
Lecture 72European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 73SPOR  - Concept of Master Data Management  
Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 74Introduction to Pharmaceutical Export
Lecture 75Introduction of Export Documentation | Understanding of important terminologies
Lecture 76Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 77Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 78Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 79Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 80Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 81Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 82LC Discounting | How it works | How to calculate the LC discounting
Lecture 83Packing List | Importance | Things to include in packing list
Lecture 84Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 85Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 86Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 87Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 88Certification Pharmaceutical Companies / Plants
Lecture 89Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 90Introduction 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 91WHO-GMP Certification Scheme 
Lecture 92Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 93Certificate of Analysis
Lecture 94Certificate of Origin (COO)
Lecture 95Non-conviction certificate
Lecture 96ISO Certification
Lecture 97Common Technical Document (CTD)
Lecture 98Electronic Common Technical Document (ECTD)
Lecture 99Dossier Preparation focusing on drug registration in export countries 
Lecture 100Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 101Importance of effective dossier management
Lecture 102Detailed Understanding on ANDA Submission Dossier 
Lecture 103Prior Approval Submission 
Lecture 104Detailed Understanding on ANDA Fees
Lecture 105Discussion on 85 common deficiency in CTD submission dossier
Lecture 106Introduction 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 107WHO-GMP Certification Scheme 
Lecture 108Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 4Plant Management and Certification | Quality Management
Lecture 109Premises & Plant Layout Designing
Lecture 110Sanitation and Hygiene
Lecture 111Equipment Modules
Lecture 112Production Modules
Lecture 113Documentation
Lecture 114Quality Control
Lecture 115Product Complaint
Lecture 116Storage Module
Lecture 117Pharmaceutical SOPs Management from regulatory perspective
Lecture 118Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 119Data Integrity issues in Pharmaceutical Industry
Lecture 120Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 121Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 5HEOR, Market Access & Pricing, Reimbursement, Forecasting
Lecture 122Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 123Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 124Introduction to Health Economics | Key terminologies related to health economics.
Lecture 125HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 126Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 127Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 128Core fundamentals of Health Economics | Clinical and economic burden | Public Health Care Payer Vs. Patient and Societal | Positioning a new treatment with the current treatment | QALY | ICER | Threshold value | Clinical trials vs health economics assessment
Lecture 129Pharmacoeconomic Evaluation Checklist | Health Economics Map | Economic evaluation cycle | Checklist of economic evaluation | Costs and Outcome relevant to different groups | Comparators | Problem of choosing the comparators
Lecture 130Pharmacoeconomic Evaluation - Resource and Cost | Fixed, Variable and Total Cost | Calculation | Average vs. marginal cost | Importance of marginal cost | Discounting | Discounting calculation | Preferable discounting rate | Sources of unit cost data | Reference costs
Lecture 131Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATP 
Lecture 132Patient Based Forecasting Model | Applying more filters and variables
Lecture 133QALY | How to calculate QALY | Importance and Significance 
Lecture 134ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Lecture 135CER and PCOR
Lecture 136Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 137Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 138Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 139AMCP Market Access Dossier Preparation 
Lecture 140Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 141Drug Pricing Methodologies - I
Lecture 142Drug Pricing Methodologies - II
Lecture 143Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 144Pharma Market Access Pricing Case Study: interchangeable Pricing 
Lecture 145Sales Forecasting in Life Science Industry
Lecture 146New Product Forecast Algorithm
Lecture 147Patient Based Forecasting Model | Applying more filters and variables
Lecture 148Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 149Prevalence Vs. Incidence Model
Lecture 150EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 151Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 152Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 153Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 154Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 155Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 156Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 157Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 158Simulation on Bottom-up forecasting
Lecture 159Assessment on Bottom-up forecasting
Lecture 160Oncology Brand Forecasting
Lecture 161Revenue Forecasting Case Study - Novel Antihypertensive 
Lecture 162Portfolio Based Forecasting | Forecasting Model Development in Excel 
Lecture 163Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 164RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 165RWD and RWE in Product Lifecycle Management
Lecture 166RWD and RWE - Fit to use | Assessment
Lecture 167RWD data sources | Different types | Detailed understanding of each class
Lecture 168First-in-class | Best-in-class | Market Access Strategic Decision Making 
Lecture 169Forecasting Biosimilar | Key Factors to consider
Lecture 170Consensus Meeting 
Lecture 171One Number Vs. Multi Number Forecasting
Lecture 172Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 173Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 174Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 175Treatment Algorithm and Forecasting : Case Based Learning
Lecture 176Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 177Prescription Value Calculation 
Section 6Pharma Global Brand Management
Lecture 178Marketing Orientation
Lecture 179Why Is Market Research Important in Pharmaceutical Business?
Lecture 180Market Research - Customer Engagement through feedback mechanism 
Lecture 181Product Life cycle 
Lecture 182Advance - Strategic Planning in Product Life cycle Management
Lecture 183Segmentation, Targeting and Positioning
Lecture 184A Pharmaceutical Segmentation outlook
Lecture 185Distribution Channel in Pharmaceutical Industry 
Lecture 186Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 187Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 188Method of Promotional Budgeting
Lecture 189Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 190Advertising - Introduction | Objective | Types of Advertising 
Lecture 191ATL, BTL & TTL Advertising
Lecture 192Advertising Agency - Understanding on various types of advertising agency
Lecture 193Selection of Advertising Agency
Lecture 194What is creative Briefing? How to Prepare !
Lecture 195Creative Briefing - Practical Simulation
Lecture 196Request for Proposal | Concepts in advertising
Lecture 197Advertising Message Strategy Development and Evaluation
Lecture 198Creative Approach and Styles
Lecture 199Steps of Development of Creatives
Lecture 200Advertisement Copy Development
Lecture 201How to prepare Ad Campaign Step By Step
Lecture 202Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 203Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 204Component of Brand Logo
Lecture 205Brand Name and Trademark Registration Process
Lecture 206Trademark Searching Process | Hands on Practical Training
Lecture 207How to design an excellent brand logo : Tricks of the trade
Lecture 208Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 209Few Case Studies related to brand names and logos
Lecture 210Can one innovator company keep 2 or more brand name?
Lecture 211Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding 
Lecture 212Global Trademarking : Brand Protection Globally 
Lecture 213Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 214Brand Logo Development: Real Life Simulation
Lecture 215Tagline - Development, Finalization and Protection
Lecture 216Pharma Brand Name Generator
Lecture 217Fundamental of Pharma Marketing Plan 
Lecture 218Basic Understanding how to launch a pharmaceutical product into the market
Lecture 219Practical Training on Marketing Plan Preparation with real life example
Lecture 220Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 221Sample Marketing Plan 
Lecture 222Decide about brand USP -What to promote 
Lecture 223How to prepare promotogram. Download sample Promotogram
Lecture 224Importance and Handling of Cycle Meeting and its importance 
Lecture 225Sample Marketing Plan
Lecture 226Sample Marketing Plan
Lecture 227Sample Marketing Plan
Lecture 228CSR Campaign 
Lecture 229Increase the brand reach with advance segmentation
Lecture 230Concept of uniform branding for better brand acceptability
Lecture 231Concept of Brand Differentiation
Lecture 232Introduction to visual aid designing  | V3M Concept | Components of the visual aid page
Lecture 233Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 234Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 235Visual Aid Analysis with practical example
Lecture 236Guideline on visual aid development
Lecture 237Marketing Plan followed by Visual Aid Development
Lecture 238Visual Aid, Literature reference Sample
Lecture 239Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 240Visual aid detailing story writing
Lecture 241Artwork Development Process in PMT Department
Lecture 242Product List and Reminder card development
Lecture 243Catch Cover Development
Lecture 244Packaging Development 
Lecture 245Prescribing Information and Patient Information Leaflet development
Lecture 246Pharma Packaging Case Studies
Lecture 247DHCP letter
Lecture 248Product Packshot Designing : Practical Knowledge
Lecture 249Creativity to develop brand essence
Lecture 250Advance Training on Pharmaceutical Packaging -  Creative Packaging for Brand Differentiation 
Lecture 251Unique identifier & anti-tampering device on outer packaging
Section 7Business Development | Licensing
Lecture 252Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 253Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 254Compound Annual Growth Rate | CAGR Calculation
Lecture 255Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 256Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 257Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 258Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 259Numerical SWOT Practical training
Lecture 260Modelling 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 261Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 262Forecasting : Tools and Techniques
Lecture 263Market Sizing & Forecasting Case Study
Lecture 264Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 265Average Royalty Rate
Lecture 266Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 267Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 268Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 269Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 270SPECIAL PURPOSE VEHICLES (SPV)
Lecture 271Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 272Types of Deals from Discovery to Commercialization
Lecture 273What are the fundamental areas of business development
Lecture 274Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 275Licensing Payment Scheduling: Different Types
Lecture 276Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 277Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 278Negotiation 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 279Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 280Types 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 281Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 8Pharma Digital Marketing
Lecture 282Introduction to Digital Marketing 
Lecture 283Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 284Digital 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 285Digital 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 286Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 287Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 288Campaign 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 289Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 290Web Host - Check the hosting details 
Lecture 291Page Speed- importance and practical understanding | Check the web speed 
Lecture 292Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 293Mobile Responsive | Tracking the Site 
Lecture 294HCP sites and Patient Site
Lecture 295Google Ad - Practical Training on Campaign Development and Execution
Lecture 296Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 297Brand Portal Development
Lecture 298Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 299Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 300Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 301Difference between FMCG and OTC Brand Ad
Lecture 302Digital Marketing Techniques
Lecture 303Video Marketing
Lecture 304Video Marketing Techniques For Small Business Owners
Lecture 305Promoting Brand through Article Advertising and Marketing
Section 9Regional Business Development : Africa
Lecture 306African Continent Overview - Brief introduction
Lecture 307African Pharma Market
Lecture 308Drug Registration - African medicines regulatory
Lecture 309Basic Export Requirement for African Countries
Lecture 310Export Documentations & Important Concepts
Lecture 311Nigeria  - Drug Registration
Lecture 312Drug Registration in Algeria
Lecture 313Drug Registration in Ethiopia
Lecture 314Drug Registration in Kenya
Lecture 315Drug Registration in Egypt
Lecture 316Drug Registration in Ghana
Lecture 317Drug Registration in Botswana
Lecture 318Drug Registration in South Africa
Lecture 319Drug Registration in Zambia
Lecture 320Drug Registration in Namibia
Lecture 321Drug Registration in Tanzania
Lecture 322Drug Registration Senegal
Lecture 323Drug Registration in Zimbabwe
Lecture 324Drug Registration in Uganda
Lecture 325Drug Registration in Morocco
Lecture 326Drug Registration in Sudan
Section 10Regional Business Development : GCC, Middle East and MENA
Lecture 327Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 328Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 329GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 330Drug Registration in Saudi Arabia
Lecture 331Drug Registration in UAE
Lecture 332Drug Registration and Regulatory Strategic Planning for Iran
Lecture 333Drug Registration and Regulatory Strategic Planning for Israel
Lecture 334Middle East Pharma Market
Lecture 335Drug Registration in Jordan
Lecture 336Drug Registration in Palestine
Section 11Regional Business Development : ASEAN
Lecture 337ASEAN - Region - Introduction
Lecture 338ASEAN Countries | Introduction | Geographical Overview 
Lecture 339ASEAN countries drug regulatory bodies
Lecture 340ASEAN Common Technical Requirements (ACTRs)
Lecture 341The Pharmaceutical Inspection Co-operation Scheme
Lecture 342CPP Requirements for Drug Registration in ASEAN countries
Lecture 343Dossier Requirements - ACTD/CTD Acceptability
Lecture 344Pharmacopoeias Acceptability
Lecture 345Harmonization of Technical Guidelines 
Lecture 346Stability Study requirements for drug registration in ASEAN countries
Lecture 347Product Labelling
Lecture 348Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 349Pharmacovigilance and Risk Management Plan (RMP)
Lecture 350Timeline of Drug Registration Approval
Lecture 351ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 352Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 353Drug Registration and Regulation in Brunei
Lecture 354Drug Registration and Regulation in Cambodia
Section 12Regional Business Development : Latam
Lecture 355Introduction to Latam Region Pharma Business Development
Lecture 356Drug Registration and Regulation in Argentina 
Lecture 357Drug Registration and Regulation in Bolivia
Lecture 358Drug Registration and Regulation in Brazil
Lecture 359Drug Registration and Regulation in Chile
Lecture 360Drug Registration and Regulation in Colombia
Lecture 361Drug Registration and Regulation in Mexico
Section 13Regional Business Development : China
Lecture 362Drug Registration and Regulation in China
Lecture 363NMPA's DDR and DMR update
Section 14References and Case Studies
Lecture 364Comparison of various requirement of drug registration
Lecture 365Comparison of Dossier requirements of US and EU
Lecture 366Comparison of DMF requirement of various regulatory bodies
Section 15Biopharmaceutical Management and Regulation
Lecture 367Introduction : Biopharmaceuticals
Lecture 368Classification of Biopharmaceutical 
Lecture 369Important Concept regarding Biopharmaceuticals
Lecture 370Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 371Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 372Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 373Global Biopahrma Market Trends
Lecture 374Recombinant protein
Lecture 375Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 376Monoclonal Antibodies
Lecture 377Synthetic Immunomodulators
Lecture 378Production of Monoclonal Antibodies
Lecture 379Cytokines
Lecture 380Interferon
Lecture 381Erythropoiesis-stimulating agent
Lecture 382Vaccine development and approval Process
Lecture 383Biosimilar Development Process
Lecture 384Strategic Consideration for Biosimilar Development 
Lecture 385Bio-Manufacturing Process Information
Lecture 386Studies required for approval of biosimilar
Section 16Drug Registration and Regulation in Japan
Lecture 387Introduction to Japan Drug Regulatory Affairs 
Lecture 388Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 389Drug Approval System | GCP | PMDA requirements 
Section 17Variation Filing : Marketing Authorization variation management
Lecture 390Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 391Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 18Bioequivalence Study : Requirements
Lecture 392PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 393Bioequivalence Study | Study design | Different types of BE Studies
Lecture 394Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 395Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 396Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 397Bioequivalence Study - Discussion - Dissolution Testing
Lecture 398Bioequivalence Study - Generic Approval and Additives Labeling Requirements