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pharma global business

introduction

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Course Code: KPE-C-024

Course Title: KPE’s Advance Diploma in Pharmaceutical Global Business

Course Objective: Executive Program in Pharmaceutical Global Business is conceptualized with vision to enhance competency of middle and middle / top level managers who are working in pharmaceutical, bio-pharmaceuticals industry. This course ideally developed for the working professionals of pharmaceutical / biopharmaceutical industry.

COURSE DESCRIPTION

Unlike other business courses that concentrate narrowly on a particular function or piece of the business—accounting, finance, marketing, production, human resources, or information systems, strategic management is a big picture course. This course focus on the real life working on the whole spectrum of pharmaceutical / bio-pharmaceutical business and management. The center of attention is the total enterprise–-the pharmaceutical industry and competitive environment in which it operates, its long-term direction and strategy, its resources and competitive capabilities, and its prospects for success. Throughout the course, the spotlight will be trained on the foremost issue in running a pharmaceutical and biopharmaceutical business enterprise: “What must managers do, and do well, to make the pharmaceutical company a winner in the game of business?” The answer that emerges, and which becomes the theme of the course, is that good strategy-making and good strategy-execution are the key ingredients of company success and the most reliable signs of good management. The mission of the course is to explore why good strategic management leads to good business performance, to present the basic concepts and tools of strategic analysis, and to drill you in the methods of crafting a well-conceived strategy and executing it competently.You’ll be called on to probe, question, and evaluate all aspects of a company’s external and internal situation. You’ll grapple with sizing up a company’s standing in the marketplace and its ability to go head-to-head with rivals, learn to tell the difference between winning strategies and mediocre strategies, and become more skilled in spotting ways to improve a company’s strategy or its execution.In the midst of all this, another purpose is accomplished: to help you synthesize what you have learned in prior business courses. Dealing with the grand sweep of how to manage all the pieces of a business makes strategic management an integrative, KPE’s Executive Program in Pharmaceutical Global Business course in which you’ll see how the various pieces of the business puzzle fit together and why the different parts of a business need to be managed in strategic harmony for the organization to operate in winning fashion.

• To develop your capacity to think strategically about a company, its present business position, its long-term direction, its resources and competitive capabilities, the caliber of its strategy, and its opportunities for gaining sustainable competitive advantage.

• To build your skills in conducting branding activities and strategic analysis in a variety of competitive situations and, especially, to provide you with a stronger understanding of the competitive challenges of a global pharmaceutical environment.

• To give you hands-on experience in crafting pharmaceutical branding, business strategy, reasoning carefully about strategic options, using what-if analysis to evaluate action alternatives, and making sound strategic decisions.

• To acquaint you with the managerial tasks associated with implementing and executing company strategies, drill you in the range of actions managers can take to promote competent strategy execution, and give you some confidence in being able to function effectively as part of a company’s strategy-implementing team.

• To develop your powers of managerial judgment, help you learn how to assess business risk, and improve your ability to make sound decisions and achieve effective outcomes.

1. Orientation to job related practical strategic business management related activities from different discipline of Pharmaceuticals.

2. Simulation to real life Strategic Pharmaceutical Management.

3. Access to Industry Data bank – 300 case studies from different pharmaceutical companies.

4. Access to Pharmaceutical and Biopharmaceutical Case Studies

5. Attend Live Lectures of all different chapters / study content.

Minimum qualification Graduation in any discipline with more than 60 months (5 Years)  of work experience in middle and top management. Work Experience is mentioned is mandatory for admission into this course. Work Experience certificate / proof need to be provided at the time of admission.

1 Year

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ADMISSION PROCESS

  • Upon completion of the admission process, 34 Modules (books) will be sent to candidates registering from India by courier. In case of admission from countries other than India, pdf modules will be provided.
  • Immediately upon admission, course participant will be provided with user id and password to access his/her personalized webpage through which he can access e-lectures, cases studies, etc. across from anywhere using internet.

Course Syllabus & Orientation:

Section 1Global Pharmaceutical R&D: Discovery to Development
Lecture 1Drug Regulation Fundamentals
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 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10Priority Accelerated Review
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12Practical Training on INDA, NDA, ANDA filing
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
Lecture 18Promotion Advertisement Regulation
Lecture 19Clinical Research : Detailed Understanding
Section 2Innovation Management in Pharmaceutical & Biopharmaceutical Industry
Lecture 20USPTO - Introduction
Lecture 21Patent
Lecture 22Patent - Practical on search and filing - USPTO
Lecture 23Trademark - Practical on TM Search & Registration Process - USPTO
Lecture 24Trademark - Practical on TM Search USPTO
Lecture 25Trademark Search assignment USPTO
Lecture 26Patent - Practical on search and filing in Indian Patent Office
Lecture 27Trademark - Practical on TM Search & Registration Process in India
Lecture 28Trademark Search assignment (India)
Lecture 29Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 3Advance Strategic Management
Lecture 30Understanding of Regulatory Strategies
Lecture 31Advance study on Para IV Filing
Lecture 32Evergreening - Patent Life Extension Strategies
Lecture 33Drug Repurposing
Lecture 34Pay For Delay Strategy
Lecture 35Pediatric Exclusivity - Case Study
Lecture 36Compulsory Licensing
Lecture 37Technology Licensing
Lecture 38Drug Pipeline and In / Outlicensing
Section 4Basic Fundamental of Pharma Production & Plant Management
Lecture 39Definition of GMP
Lecture 40Introduction to Good Manufacturing Practices
Lecture 41Premises & Plant Layout Designing
Lecture 42Sanitation and Hygiene
Lecture 43Equipment Modules
Lecture 44Production Modules
Lecture 45Documentation
Lecture 46Quality Control
Lecture 47G7 Lecture Product Complaint
Lecture 48G8 Lecture Storage Module
Lecture 49ISO and ISO Audits
Lecture 50Pharmaceutical SOPs Management from regulatory perspective
Lecture 51SOP Automation in Pharmaceutical Industry
Lecture 52USFDA warning Letter & CAPA
Lecture 53USFDA Warning Letter
Lecture 54Handling of warning letter
Lecture 55Case Study - Warning Letter
Lecture 56Detailed Understanding of DMF & SMF
Section 5Global Business : European Union
Lecture 57Global Business: Different Business Region Terminologies
Lecture 58Introduction to EU Regulation
Lecture 59Orientation to European Countries and National Regulatory Bodies
Lecture 60Overview of EU Regulation
Lecture 61EMEA Procedures
Lecture 62Summary of Product Characteristics
Lecture 63Compassionate Use
Lecture 64MHRA - UK Regulation
Lecture 65EU Orphan Medicinal Products Regulation
Section 6Global Business : GCC countries
Lecture 66GCC Pharma Market
Lecture 67GCC Export – Local Partner
Lecture 68GCC Registration Procedure
Lecture 69Drug Registration in Saudi Arabia
Lecture 70Documentation Required for the GCC countries
Lecture 71Drug Registration in GCC countries
Lecture 72Medical Device Regulation in GCC countries
Section 7Drug Registration Dossier
Lecture 73Introduction to Common Technical Document (CTD)
Lecture 74Asean Common Technical Document (ACTD)
Lecture 75Introduction to Electronic Common Technical Document (ECTD)
Lecture 76Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 77Modules on Stability Study 1
Lecture 78Stability Study Test
Lecture 79Module on Interchangeability
Lecture 80Stability Testing of API
Lecture 81Stability Testing of Finished Pharmaceutical Products
Lecture 82Review Test on Stability Testing
Section 8Global Business : ASEAN countries
Lecture 83ASEAN Drug Regulatory Affairs
Lecture 84Asean Geography
Lecture 85Drug Registration in Brunei
Lecture 86Drug Registration in Malaysia
Lecture 87Drug Registration in Cambodia
Lecture 88Drug Registration in Mayanmar
Lecture 89Drug Registration in Philippines
Lecture 90Drug Registration in Singapore
Section 9Pharmaceutical Business in India
Lecture 91Drug Regulation in India - CDSCO
Lecture 92National Pharmaceutical Pricing Authority
Lecture 93Drug Price Regulation in India
Lecture 94Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 95Drug Price Control Order 2013
Lecture 96Case Study of New Drug Approval in India
Section 10Introduction to Pharma Product Management
Lecture 97Introduction to Pharma Product Management
Lecture 98Detailed Understanding of Product Management Job
Section 11Marketing Orientation for Product Manager
Lecture 99Marketing Orientation for Product Manager
Lecture 100Why Is Market Research Important in Pharmaceutical Business?
Lecture 101Consumer buying behavior
Lecture 102Consumer buying behavior
Lecture 103Segmentation
Lecture 104Pricing
Lecture 105Distribution and Logistics
Lecture 106Segmentation, Targeting and Positioning
Lecture 107A Pharmaceutical Segmentation outlook
Lecture 108Place / Distribution
Lecture 109Promotion Management Process
Lecture 110Setting and Quantifying Promotional Objectives
Lecture 111Break even analysis
Lecture 112Basics of Advertising : Introduction
Lecture 113Classifications of Advertising
Lecture 114The Advertising agency
Section 12Practical Training on Pharma Brand Logo Development
Lecture 115Brand Logo - Introduction
Lecture 116Purpose of Brand Logo
Lecture 117Component of Brand Logo
Lecture 118Trademark Registration
Lecture 119Trademark - Practical on TM Search
Lecture 120Trademark Search assignment
Lecture 121How to design excellent brand logo?
Lecture 122How to design excellent brand logo?
Lecture 123Color Systems - RGB & CMYK
Lecture 124Few Case Studies related to brand names and logos
Lecture 125Brand Logo - Simulation
Lecture 126Colour Trademarking in Pharma Branding
Lecture 127How to protect pharma brands globally?
Lecture 128Rebranding in Pharmaceuticals
Lecture 129Brand Logo Development: Real Life Simulation
Section 13Advance Pharma Brand Management - 1
Lecture 130 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 131Marketing Campaign Development
Lecture 132How to prepare a Pharma Brand Plan
Lecture 133Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 134Decide about brand USP -What to promote
Lecture 135How to prepare promotogram. Download sample Promotogram
Lecture 136Importance and Handling of Cycle Meeting and its importance
Lecture 137Sample Marketing Plan : Febuxostat
Lecture 138Sample Marketing Plan : Orlistat
Lecture 139New Product Launch Case Study
Lecture 140Brand Launch Case Study
Lecture 141Aristada - Launch Case Study
Lecture 142CSR Campaign
Lecture 143Cost Based Working for Sample Allocation
Section 14Advance Pharma Brand Management - 2
Lecture 144Importance of Visual Aid in Pharmaceutical Industry
Lecture 145Fundamentals of preparing visual aid
Lecture 146Indications for Drugs: Approved vs. Non-approved
Lecture 147Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 148Step by step visual aid development process
Lecture 149 Guideline of Visual Aid Designing
Lecture 150Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 151VISUAL AID PRINTING
Lecture 152Detailing and e-detailing
Lecture 153Visual Aid Development Process Review
Lecture 154Visual Aid, Literature reference Sample
Lecture 155Tablet vs. Conventional Detailing
Lecture 156Celebrity Endorsement in Pharmaceuticals
Lecture 157Conference Management
Section 15Practical Training on Packaging Development
Lecture 158Artwork Development Process in PMT Department
Lecture 159Product List and Reminder card development
Lecture 160Catch Cover Development
Lecture 161Packaging Development
Lecture 162Prescribing Information and Patient Information Leaflet development
Lecture 163Pharma Packaging Case Studies
Section 16Analytics
Lecture 164Moving annual total (MAT)
Lecture 165Compound Annual Growth Rate (CAGR)
Lecture 166Analytical Approach in Determining Brand Potential with case study
Section 17Advance Strategic Management
Lecture 167Co-promotion & Co-marketing strategy in pharma industry
Lecture 168Concept of Reverse co-promotion in pharma industry
Lecture 169In-Licensing Vs. Outlicensing
Lecture 170Importance of Publications in Pharmaceutical Industry
Lecture 171Juxtapid Case Study
Lecture 172New Indication Approval Process and Promotion
Section 18Fundamental understanding in Finance
Section 19Access to Case study directory
Section 20Project & Portfolio Management
Lecture 175Introduction: Project Management
Lecture 176Difference between Project and Program
Lecture 177Program/Project Leadership versus Stage
Lecture 178Project Management Constraint
Lecture 179Key to Project Success
Lecture 180PERT, CPM, Critical Path, Project Diagram and its components
Lecture 181Qualities of a Good Project Leader
Lecture 182Qualities of a Good Team Representative
Lecture 183Project Tracking in Drug Discovery Projects
Lecture 184Project Benchmarking through a Consortium
Lecture 185Cycle Times (Stage or phase lengths)
Lecture 186he proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 187What is a milestone chart?
Lecture 188Project Termination and Project Reinitiation
Lecture 189Asset Tracking
Lecture 190Levels of Project and Portfolio Management
Lecture 191Functions of Portfolio Management Team
Lecture 192Importance of Periodic Portfolio Reviews
Lecture 193Portfolio Prioritization