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TypeOnline Course
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pharma global management

Introduction

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Course Duration

Eligibility

Certification

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About Pharma Management

Add on Certification

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. 

Course Code: RYD-080

Title: Executive PG Certification in Pharma Global Management (EPPGB)

Type of the course: Self paced Online Course

Online distance learning 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.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of 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. Hence the course provides
  • 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

pharma global management course offer

  • The participants of Global Business Registrant will get two add on certification.
  • Participant can choose add on courses of any 1 month or 1 week / 3 Days certification course. One can choose the desire course from following course list
  • Participant can activate the add on course anytime during 1 year active course duration.
  • On completion of add on course, participant will be issuing course certificate.
  • You can activate this add on course anytime during the active 1 year course tenure.
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
Section 6Pharma Global Brand Management
Lecture 173Marketing Orientation
Lecture 174Why Is Market Research Important in Pharmaceutical Business?
Lecture 175Market Research - Customer Engagement through feedback mechanism 
Lecture 176Product Life cycle 
Lecture 177Advance - Strategic Planning in Product Life cycle Management
Lecture 178Segmentation, Targeting and Positioning
Lecture 179A Pharmaceutical Segmentation outlook
Lecture 180Distribution Channel in Pharmaceutical Industry 
Lecture 181Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 182Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 183Method of Promotional Budgeting
Lecture 184Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 185Advertising - Introduction | Objective | Types of Advertising 
Lecture 186ATL, BTL & TTL Advertising
Lecture 187Advertising Agency - Understanding on various types of advertising agency
Lecture 188Selection of Advertising Agency
Lecture 189What is creative Briefing? How to Prepare !
Lecture 190Creative Briefing - Practical Simulation
Lecture 191Request for Proposal | Concepts in advertising
Lecture 192Advertising Message Strategy Development and Evaluation
Lecture 193Creative Approach and Styles
Lecture 194Steps of Development of Creatives
Lecture 195Advertisement Copy Development
Lecture 196How to prepare Ad Campaign Step By Step
Lecture 197Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 198Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 199Component of Brand Logo
Lecture 200Brand Name and Trademark Registration Process
Lecture 201Trademark Searching Process | Hands on Practical Training
Lecture 202How to design an excellent brand logo : Tricks of the trade
Lecture 203Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 204Few Case Studies related to brand names and logos
Lecture 205Can one innovator company keep 2 or more brand name?
Lecture 206Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding 
Lecture 207Global Trademarking : Brand Protection Globally 
Lecture 208Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 209Brand Logo Development: Real Life Simulation
Lecture 210Tagline - Development, Finalization and Protection
Lecture 211Pharma Brand Name Generator
Lecture 212Fundamental of Pharma Marketing Plan 
Lecture 213Basic Understanding how to launch a pharmaceutical product into the market
Lecture 214Practical Training on Marketing Plan Preparation with real life example
Lecture 215Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 216Sample Marketing Plan 
Lecture 217Decide about brand USP -What to promote 
Lecture 218How to prepare promotogram. Download sample Promotogram
Lecture 219Importance and Handling of Cycle Meeting and its importance 
Lecture 220Sample Marketing Plan
Lecture 221Sample Marketing Plan
Lecture 222Sample Marketing Plan
Lecture 223CSR Campaign 
Lecture 224Increase the brand reach with advance segmentation
Lecture 225Concept of uniform branding for better brand acceptability
Lecture 226Concept of Brand Differentiation
Lecture 227Introduction to visual aid designing  | V3M Concept | Components of the visual aid page
Lecture 228Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 229Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 230Visual Aid Analysis with practical example
Lecture 231Guideline on visual aid development
Lecture 232Marketing Plan followed by Visual Aid Development
Lecture 233Visual Aid, Literature reference Sample
Lecture 234Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 235Visual aid detailing story writing
Lecture 236Artwork Development Process in PMT Department
Lecture 237Product List and Reminder card development
Lecture 238Catch Cover Development
Lecture 239Packaging Development 
Lecture 240Prescribing Information and Patient Information Leaflet development
Lecture 241Pharma Packaging Case Studies
Lecture 242DHCP letter
Lecture 243Product Packshot Designing : Practical Knowledge
Lecture 244Creativity to develop brand essence
Lecture 245Advance Training on Pharmaceutical Packaging -  Creative Packaging for Brand Differentiation 
Lecture 246Unique identifier & anti-tampering device on outer packaging
Section 7Business Development | Licensing
Lecture 247Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 248Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 249Compound Annual Growth Rate | CAGR Calculation
Lecture 250Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 251Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 252Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 253Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 254Numerical SWOT Practical training
Lecture 255Modelling 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 256Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 257Forecasting : Tools and Techniques
Lecture 258Market Sizing & Forecasting Case Study
Lecture 259Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 260Average Royalty Rate
Lecture 261Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 262Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 263Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 264Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 265SPECIAL PURPOSE VEHICLES (SPV)
Lecture 266Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 267Types of Deals from Discovery to Commercialization
Lecture 268What are the fundamental areas of business development
Lecture 269Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 270Licensing Payment Scheduling: Different Types
Lecture 271Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 272Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 273Negotiation 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 274Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 275Types 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 276Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 8Pharma Digital Marketing
Lecture 277Introduction to Digital Marketing 
Lecture 278Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 279Digital 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 280Digital 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 281Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 282Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 283Campaign 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 284Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 285Web Host - Check the hosting details 
Lecture 286Page Speed- importance and practical understanding | Check the web speed 
Lecture 287Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 288Mobile Responsive | Tracking the Site 
Lecture 289HCP sites and Patient Site
Lecture 290Google Ad - Practical Training on Campaign Development and Execution
Lecture 291Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 292Brand Portal Development
Lecture 293Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 294Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 295Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 296Difference between FMCG and OTC Brand Ad
Lecture 297Digital Marketing Techniques
Lecture 298Video Marketing
Lecture 299Video Marketing Techniques For Small Business Owners
Lecture 300Promoting Brand through Article Advertising and Marketing
Section 9Regional Business Development : Africa
Lecture 301African Continent Overview - Brief introduction
Lecture 302African Pharma Market
Lecture 303Drug Registration - African medicines regulatory
Lecture 304Basic Export Requirement for African Countries
Lecture 305Export Documentations & Important Concepts
Lecture 306Nigeria  - Drug Registration
Lecture 307Drug Registration in Algeria
Lecture 308Drug Registration in Ethiopia
Lecture 309Drug Registration in Kenya
Lecture 310Drug Registration in Egypt
Lecture 311Drug Registration in Ghana
Lecture 312Drug Registration in Botswana
Lecture 313Drug Registration in South Africa
Lecture 314Drug Registration in Zambia
Lecture 315Drug Registration in Namibia
Lecture 316Drug Registration in Tanzania
Lecture 317Drug Registration Senegal
Lecture 318Drug Registration in Zimbabwe
Lecture 319Drug Registration in Uganda
Lecture 320Drug Registration in Morocco
Lecture 321Drug Registration in Sudan
Section 10Regional Business Development : GCC, Middle East and MENA
Lecture 322Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 323Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 324GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 325Drug Registration in Saudi Arabia
Lecture 326Drug Registration in UAE
Lecture 327Drug Registration and Regulatory Strategic Planning for Iran
Lecture 328Drug Registration and Regulatory Strategic Planning for Israel
Lecture 329Middle East Pharma Market
Lecture 330Drug Registration in Jordan
Lecture 331Drug Registration in Palestine
Section 11Regional Business Development : ASEAN
Lecture 332ASEAN - Region - Introduction
Lecture 333ASEAN Countries | Introduction | Geographical Overview 
Lecture 334ASEAN countries drug regulatory bodies
Lecture 335ASEAN Common Technical Requirements (ACTRs)
Lecture 336The Pharmaceutical Inspection Co-operation Scheme
Lecture 337CPP Requirements for Drug Registration in ASEAN countries
Lecture 338Dossier Requirements - ACTD/CTD Acceptability
Lecture 339Pharmacopoeias Acceptability
Lecture 340Harmonization of Technical Guidelines 
Lecture 341Stability Study requirements for drug registration in ASEAN countries
Lecture 342Product Labelling
Lecture 343Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 344Pharmacovigilance and Risk Management Plan (RMP)
Lecture 345Timeline of Drug Registration Approval
Lecture 346ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 347Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 348Drug Registration and Regulation in Brunei
Lecture 349Drug Registration and Regulation in Cambodia
Section 12Regional Business Development : Latam
Lecture 350Introduction to Latam Region Pharma Business Development
Lecture 351Drug Registration and Regulation in Argentina 
Lecture 352Drug Registration and Regulation in Bolivia
Lecture 353Drug Registration and Regulation in Brazil
Lecture 354Drug Registration and Regulation in Chile
Lecture 355Drug Registration and Regulation in Colombia
Lecture 356Drug Registration and Regulation in Mexico
Section 13Regional Business Development : China
Lecture 357Drug Registration and Regulation in China
Lecture 358NMPA's DDR and DMR update
Section 14References and Case Studies
Lecture 359Comparison of various requirement of drug registration
Lecture 360Comparison of Dossier requirements of US and EU
Lecture 361Comparison of DMF requirement of various regulatory bodies
Section 15Biopharmaceutical Management and Regulation
Lecture 362Introduction : Biopharmaceuticals
Lecture 363Classification of Biopharmaceutical 
Lecture 364Important Concept regarding Biopharmaceuticals
Lecture 365Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 366Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 367Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 368Global Biopahrma Market Trends
Lecture 369Recombinant protein
Lecture 370Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 371Monoclonal Antibodies
Lecture 372Synthetic Immunomodulators
Lecture 373Production of Monoclonal Antibodies
Lecture 374Cytokines
Lecture 375Interferon
Lecture 376Erythropoiesis-stimulating agent
Lecture 377Vaccine development and approval Process
Lecture 378Biosimilar Development Process
Lecture 379Strategic Consideration for Biosimilar Development 
Lecture 380Bio-Manufacturing Process Information
Lecture 381Studies required for approval of biosimilar
Section 16Drug Registration and Regulation in Japan
Lecture 382Introduction to Japan Drug Regulatory Affairs 
Lecture 383Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 384Drug Approval System | GCP | PMDA requirements 
Section 17Variation Filing : Marketing Authorization variation management
Lecture 385Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 386Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 18Bioequivalence Study : Requirements
Lecture 387PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 388Bioequivalence Study | Study design | Different types of BE Studies
Lecture 389Bioequivalence 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 390Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 391Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 392Bioequivalence Study - Discussion - Dissolution Testing
Lecture 393Bioequivalence Study - Generic Approval and Additives Labeling Requirements