InstructorRoyed Training
TypeOnline Course
Price$650 / 32500 INR.
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biopharma global business

Introduction

Core Learning Areas

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

About Pharma Management

Add on Certification

Executive program in biopharma global business

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

In these online self-paced modules, participants understand 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 working in biopharmaceutical industry.
  • Professionals who are working in the regulatory affairs and related department.
  • Professionals from corporate and strategic management. 
  • This course suits those who are handling the biopharmaceutical development and licensing department.
  • This pharma global management course is ideal for the senior management professionals working in biopharmaceutical project management.
  • Anyone requiring an overview and detailed understanding on working of biopharmaceutical management. 
  • Fresher or beginners, Those who want to make a career in the management in pharmaceutical and biopharmaceutical companies.

Course Code: RYD-093

Title: Executive PG Certification in Biopharma Global Business (EPGBGB)

Type of the course: Self paced Online Course

Core learning areas of Biopharma Global Business Course

The Biopharma Global Business Course covers following :

  • Biopharmaceutical basics and different classes of biopharmaceuticals
  • Discovery Development to commercialization of biopharmaceutical.
  • Market Access, Pricing, Forecasting.
  • Strategic Management of biopharmaceutical products
  • Regulatory affairs (regulation, marketing authorization, variation, etc) of innovator biologics and similar biologics.
  • Business Development, Valuation, Licensing of biopharmaceutical deals.
  • Biopharmaceutical Brand Management.
  • Biopharmaceutical international marketing and export documentation.
  • Advanced digital marketing for biopharmaceuticals.

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, if you want to attend the session at 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 Biopharma Global Business

  • This biopharma global business training covers all aspects of the strategic management from drug discovery development, market access, pricing, forecasting, regulatory, marketing, branding, business development, licensing 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 hands-on understanding of how Business Development Professional works.
  • One of the important features of the course is real life simulation on critical decision making processes. Hence, these simulations help to enhance the licensing and  decision making skills which are the core aspects of the pharmaceutical management working.

Case Based Learning is the key in biopharma global business course

  • Advance training on biopharmaceutical strategic management based on the various business regions.
  • Course covers regional biopharmaceutical 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 biopharma strategic portfolio management.

Career in Biopharma Global Business

One of the fastest growing industries in is biopharmaceuticals. Hence the job market offers multiple opportunities for life science professionals as biotech companies work everyday to create successful products and place them in the marketplace. In biopharmaceutical industry scientists and researchers are key people who always preferred because of their biopharma subject knowledge. While these individuals have the academic and scientific background, they may not have the strategic management skills to manage biopharmaceutical business. Hence, this course provides necessary training to skill up the biopharmaceutical professionals.

In biopharmaceutical industry, strategic manager oversee the process of discovery, development and commercialization. They determine the biopharmaceutical products scope, timelines, budget and procurement, market access, regulatory, quality controls, marketing strategies, etc.

What are the areas biopharma global business professionals can make a career in biopharmaceutical company?

Biopharmaceutical Global Business Professionals will have option to join or work in following departments :

  • R&D Project Management
  • Strategic Management
  • Market Access
  • Global Pricing
  • Regulatory Affairs
  • Business Development
  • Licensing Department (Inlicensing or Outlicensing)
  • Brand Management
  • Marketing and Sales Management

Specific Knowledge of the various business regions is important for biopharmaceutical business management

There is no doubt that the biopharmaceutical industry is growing at a rapid pace. In fact Biologic is the future of medicine. However there is a rising concern over the safety and efficacy. Hence, the major objective of the biopharmaceutical management professionals is to learn various regional regulatory and business development knowledge. In fact, regional biopharma knowledge will help them to become successful in international business management. Moreover, the biopharma business development landscape is evolving and changing every other day. Biopharma management professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decisions effectively. Therefore, this course is an ideal choice for the biopharmaceutical management course which covers various domains.

Add on Certification

  • The participants of Global Business Registrant will get two add-on certifications.
  • Hence participants can choose add on courses of any 1 month or 1 week / 3 Days certification course. One can choose the desired course from the following course list
  • Participants can activate the add on course anytime during 1 year active course duration.
  • On completion of the add-on course, participants will be issued a course certificate. Hence, apart from the biopharma global management certification, participants will receive 2 add-on course certificates without any additional cost.
  • You can activate this add on course anytime during the active 1 year course tenure.
Section 1Biopharma R&D Process & Introduction to discovery, development to commercialization process
Lecture 1Biopharma R&D Process & Introduction to discovery, development to commercialization process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
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 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Vaccine development and approval Process
Lecture 10Handling of orange book
Lecture 11Purple Book: Significance | Searching | Assignments
Lecture 12Clinical Trials Terminologies 
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 2Biopharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 16Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 17Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 18Market Access Strategic Planning
Lecture 19Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 20Indication Prioritization Case Study
Lecture 21Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 22AMCP Market Access Value Dossier Preparation
Lecture 23Drug Pricing Methodologies
Lecture 24Sales Forecasting in Life Science Industry
Lecture 25New Product Forecast Algorithm
Lecture 26Patient Based Forecasting Model | Applying more filters and variables
Lecture 27Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 28Prevalence Vs. Incidence Model
Lecture 29EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 30Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 31Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 32Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 33Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 34Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 35Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 36Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 37Simulation on Bottom-up forecasting
Lecture 38Assessment on Bottom-up forecasting
Lecture 39Oncology Brand Forecasting
Lecture 40Authorized Geenric
Lecture 41Branded Generics | Differences from Authorized and Unbranded Generics | Strategic planning for formulary placement 
Section 3Biopharma Business Development | Licensing
Lecture 42Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 43Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 44Compound Annual Growth Rate | CAGR Calculation
Lecture 45Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 46Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 47Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 48Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 49Numerical SWOT Practical training
Lecture 50Modelling 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 51Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 52Forecasting : Tools and Techniques
Lecture 53Market Sizing & Forecasting Case Study
Lecture 54Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 55Average Royalty Rate
Lecture 56Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 57Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 58Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 59Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 60SPECIAL PURPOSE VEHICLES (SPV)
Lecture 61Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 62Types of Deals from Discovery to Commercialization
Lecture 63What are the fundamental areas of business development
Lecture 64Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 65Licensing Payment Scheduling: Different Types
Lecture 66Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 67Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 68Negotiation 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 69Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 70Types 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 71Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 4Biopharma Digital Marketing
Lecture 72Introduction to Digital Marketing 
Lecture 73Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 74Digital 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 75Digital 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 76Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 77Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 78Campaign 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 79Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 80Web Host - Check the hosting details 
Lecture 81Page Speed- importance and practical understanding | Check the web speed 
Lecture 82Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 83Mobile Responsive | Tracking the Site 
Lecture 84HCP sites and Patient Site
Lecture 85Google Ad - Practical Training on Campaign Development and Execution
Lecture 86Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 87Brand Portal Development
Lecture 88Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 89Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 90Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 91Difference between FMCG and OTC Brand Ad
Lecture 92Digital Marketing Techniques
Lecture 93Video Marketing
Lecture 94Video Marketing Techniques For Small Business Owners
Lecture 95Promoting Brand through Article Advertising and Marketing
Section 5Biopharmaceutical Management and Regulation
Lecture 96Introduction : Biopharmaceuticals
Lecture 97Classification of Biopharmaceutical 
Lecture 98Important Concept regarding Biopharmaceuticals
Lecture 99Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 100Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 101Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 102Global Biopahrma Market Trends
Lecture 103Recombinant protein
Lecture 104Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 105Monoclonal Antibodies
Lecture 106Synthetic Immunomodulators
Lecture 107Production of Monoclonal Antibodies
Lecture 108Cytokines
Lecture 109Interferon
Lecture 110Erythropoiesis-stimulating agent
Lecture 111Vaccine development and approval Process
Lecture 112Biosimilar Development Process
Lecture 113Strategic Consideration for Biosimilar Development 
Lecture 114Bio-Manufacturing Process Information
Lecture 115Studies required for approval of biosimilar
Lecture 116REMS Strategic Planning 
Section 6Biopharma Strategic Management
Lecture 117Patents Vs. exclusivity 
Lecture 118Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 119Orphan Drug Designation 
Lecture 120USFDA expedited programs
Lecture 121Advance study on Para IV Filing
Lecture 122Para IV Notices
Lecture 123Evergreening - Patent Life Extension Strategies
Lecture 124Pay For Delay Strategy
Lecture 125Compulsory Licensing
Lecture 126Licensing & Technology Transfer
Lecture 127In-Licensing Vs. Outlicensing
Lecture 128LOE Strategies for Innovator Brands with case study
Lecture 129Drug Repurposing
Lecture 130Advance understanding of the portfolio Management 
Section 7Advance Biopharma Regulations and Submission Management
Lecture 131505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 132Advance Learning on 505B2 Pathway
Lecture 133Chemistry, Manufacturing & Controls 
Lecture 134Common Technical Document (CTD)
Lecture 135Introduction to Electronic Common Technical Document (ECTD)
Lecture 136Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 137Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 138Importance of effective dossier management
Lecture 139Certificate of Analysis
Lecture 140Detailed Understanding on ANDA Submission Dossier 
Lecture 141Prior Approval Submission 
Lecture 142Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 143NCE Vs. 505b2 application - Case Based Learning 
Lecture 144FTF - 180 Days Exclusivity - Case Based Learning
Lecture 145Classic case study of the 505b2 filing : Case Based Learning
Lecture 146Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 147Discussion on 85 common deficiency in CTD submission dossier
Lecture 148Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 149PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 150Bioequivalence Study | Study design | Different types of BE Studies
Lecture 151Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalization | Confidence interval acceptance criteria
Lecture 152Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 153Data Integrity issues in Pharmaceutical Industry
Section 8Biopharma International Business
Lecture 154Introduction to Pharmaceutical Export
Lecture 155Introduction of Export Documentation | Understanding of important terminologies
Lecture 156Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 157Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 158Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 159Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 160Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 161Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 162LC Discounting | How it works | How to calculate the LC discounting
Lecture 163Packing List | Importance | Things to include in packing list
Lecture 164Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 165Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 166Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 167Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 168Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation