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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, biotech, medical devices and allied industry. This course ideally developed for the working professionals of pharmaceutical 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. It cuts across the whole spectrum of 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.

• To help you become more proficient in using personal computers to do managerial analysis and managerial work

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

Rs. 38500/- Indian Rupees (For admission from India)

780 USD (For payment outside India)

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ADMISSION PROCESS

  • Upon completion of the admission process, 35 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
Section 2Clinical Research
Lecture 18Clinical Trials Terminologies (Lecture 1-11)
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3Innovation Management Process in Pharma
Lecture 22USPTO - Introduction
Lecture 23Patent
Lecture 24Patent - Practical on search and filing - USPTO
Lecture 25Trademark - Practical on TM Search & Registration Process - USPTO
Lecture 26Trademark - Practical on TM Search USPTO
Lecture 27Trademark Search assignment USPTO
Lecture 28Patent - Practical on search and filing in Indian Patent Office
Lecture 29Trademark - Practical on TM Search & Registration Process in India
Lecture 30Trademark Search assignment (India)
Lecture 31Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 32Regulatory Strategies in different phases of Clinical Trial
Lecture 33Advance study on Para IV Filing
Lecture 34Evergreening - Patent Life Extension Strategies
Lecture 35Drug Repurposing
Lecture 36Pay For Delay Strategy
Lecture 37Pediatric Exclusivity - Case Study
Lecture 38Compulsory Licensing
Lecture 39Technology Licensing
Lecture 40Drug Pipeline and In / Outlicensing
Section 5GMP
Lecture 41Definition of GMP
Lecture 42ProjectCertification Pharmaceutical Companies / Plants
Lecture 43Introduction to Good Manufacturing Practices
Lecture 44Premises & Plant Layout Designing
Lecture 45Sanitation and Hygiene
Lecture 46Equipment Modules
Lecture 47Production Modules
Lecture 48Documentation
Lecture 49Quality Control
Lecture 50G7 Lecture Product Complaint
Lecture 51G8 Lecture Storage Module
Lecture 52ISO and ISO Audits
Lecture 53Pharmaceutical SOPs Management from regulatory perspective
Lecture 54SOP Automation in Pharmaceutical Industry
Lecture 55USFDA warning Letter & CAPA
Lecture 56USFDA Warning Letter
Lecture 57Handling of warning letter
Lecture 58Case Study - Warning Letter
Section 6DMF & SMF
Lecture 59DMF & SMF
Lecture 60Regulatory Strategies in different phases of Clinical Trial
Lecture 61Advance understanding of the portfolio Management
Section 7EU Regulations
Lecture 62Global Business: Different Business Region Terminologies
Lecture 63Introduction to EU Regulation
Lecture 64Orientation to European Countries and National Regulatory Bodies
Lecture 65Overview of EU Regulation
Lecture 66EMEA Procedures
Lecture 67Summary of Product Characteristics
Lecture 68Compassionate Use
Lecture 69MHRA - UK Regulation
Lecture 70EU Orphan Medicinal Products Regulation
Section 8Pharma Business : GCC countries
Lecture 71GCC Pharma Market
Lecture 72GCC Export – Local Partner
Lecture 73GCC Registration Procedure
Lecture 74Drug Registration in Saudi Arabia
Lecture 75Documentation Required for the GCC countries
Lecture 76Drug Registration in GCC countries
Lecture 77Medical Device Regulation in GCC countries
Section 9Drug Registration Dossier
Lecture 78Introduction to Common Technical Document (CTD)
Lecture 79Asean Common Technical Document (ACTD)
Lecture 80Introduction to Electronic Common Technical Document (ECTD)
Lecture 81Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 82Modules on Stability Study 1
Lecture 83Stability Study Test
Lecture 84Module on Interchangeability
Lecture 85Stability Testing of API
Lecture 86Stability Testing of Finished Pharmaceutical Products
Lecture 87Review Test on Stability Testing
Section 10Pharma Business : ASEAN countries
Lecture 88ASEAN Drug Regulatory Affairs
Lecture 89Asean Geography
Lecture 90Drug Registration in Brunei
Lecture 91Drug Registration in Malaysia
Lecture 92Drug Registration in Cambodia
Lecture 93Drug Registration in Mayanmar
Lecture 94Drug Registration in Philippines
Lecture 95Drug Registration in Singapore
Section 11Drug Regulation in India - CDSCO
Lecture 96Drug Regulation in India - CDSCO
Lecture 97National Pharmaceutical Pricing Authority
Lecture 98Drug Price Regulation in India
Lecture 99Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 100Drug Price Control Order 2013
Lecture 101Case Study of New Drug Approval in India
Section 12Introduction to Pharma Product Management
Lecture 102Introduction to Pharma Product Management
Lecture 103Detailed Understanding of Product Management Job
Section 13Marketing Orientation for Product Manager
Lecture 104Marketing Orientation for Product Manager
Lecture 105Why Is Market Research Important in Pharmaceutical Business?
Lecture 106Consumer buying behavior
Lecture 107Consumer buying behavior
Lecture 108Segmentation
Lecture 109Pricing
Lecture 110Distribution and Logistics
Lecture 111Segmentation, Targeting and Positioning
Lecture 112A Pharmaceutical Segmentation outlook
Lecture 113Place / Distribution
Lecture 114Promotion Management Process
Lecture 115Setting and Quantifying Promotional Objectives
Lecture 116Break even analysis
Lecture 117Basics of Advertising : Introduction
Lecture 118Classifications of Advertising
Lecture 119The Advertising agency
Section 14Practical Training on Pharma Brand Logo Development
Lecture 120Brand Logo - Introduction
Lecture 121Purpose of Brand Logo
Lecture 122Component of Brand Logo
Lecture 123Trademark Registration
Lecture 124Trademark - Practical on TM Search
Lecture 125Trademark Search assignment
Lecture 126How to design excellent brand logo?
Lecture 127How to design excellent brand logo?
Lecture 128Color Systems - RGB & CMYK
Lecture 129Few Case Studies related to brand names and logos
Lecture 130Brand Logo - Simulation
Lecture 131Colour Trademarking in Pharma Branding
Lecture 132How to protect pharma brands globally?
Lecture 133Rebranding in Pharmaceuticals
Lecture 134Brand Logo Development: Real Life Simulation
Section 15
Lecture 135 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 136Marketing Campaign Development
Lecture 137How to prepare a Pharma Brand Plan
Lecture 138Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 139Decide about brand USP -What to promote
Lecture 140How to prepare promotogram. Download sample Promotogram
Lecture 141Importance and Handling of Cycle Meeting and its importance
Lecture 142Sample Marketing Plan : Febuxostat
Lecture 143Sample Marketing Plan : Orlistat
Lecture 144New Product Launch Case Study
Lecture 145Brand Launch Case Study
Lecture 146Aristada - Launch Case Study
Lecture 147CSR Campaign
Lecture 148Cost Based Working for Sample Allocation
Section 16
Lecture 149Importance of Visual Aid in Pharmaceutical Industry
Lecture 150Fundamentals of preparing visual aid
Lecture 151Indications for Drugs: Approved vs. Non-approved
Lecture 152Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 153Step by step visual aid development process
Lecture 154 Guideline of Visual Aid Designing
Lecture 155Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 156VISUAL AID PRINTING
Lecture 157Detailing and e-detailing
Lecture 158Visual Aid Development Process Review
Lecture 159Visual Aid, Literature reference Sample
Lecture 160Tablet vs. Conventional Detailing
Section 17Practical Training on Packaging Development
Lecture 161Artwork Development Process in PMT Department
Lecture 162Product List and Reminder card development
Lecture 163Catch Cover Development
Lecture 164Packaging Development
Lecture 165Prescribing Information and Patient Information Leaflet development
Lecture 166Pharma Packaging Case Studies
Section 18Analytics
Lecture 167Moving annual total (MAT)
Lecture 168Compound Annual Growth Rate (CAGR)
Lecture 169Analytical Approach in Determining Brand Potential with case study
Section 19
Lecture 170Co-promotion & Co-marketing strategy in pharma industry
Lecture 171Concept of Reverse co-promotion in pharma industry
Lecture 172In-Licensing Vs. Outlicensing
Lecture 173Importance of Publications in Pharmaceutical Industry
Lecture 174Juxtapid Case Study
Lecture 175New Indication Approval Process and Promotion
Section 20Fundamental understanding in Finance
Section 21Access to Case study directory
Section 22Conference Management
Section 23Promotion Advertisement Regulations
Section 24Celebrity Endorsement in Pharmaceuticals
Section 25Project & Portfolio Management
Lecture 181Introduction: Project Management
Lecture 182Difference between Project and Program
Lecture 183Program/Project Leadership versus Stage
Lecture 184Project Management Constraint
Lecture 185Key to Project Success
Lecture 186PERT, CPM, Critical Path, Project Diagram and its components
Lecture 187Qualities of a Good Project Leader
Lecture 188Qualities of a Good Team Representative
Lecture 189Project Tracking in Drug Discovery Projects
Lecture 190Project Benchmarking through a Consortium
Lecture 191Cycle Times (Stage or phase lengths)
Lecture 192he proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 193What is a milestone chart?
Lecture 194Project Termination and Project Reinitiation
Lecture 195Asset Tracking
Lecture 196Levels of Project and Portfolio Management
Lecture 197Functions of Portfolio Management Team
Lecture 198Importance of Periodic Portfolio Reviews
Lecture 199Portfolio Prioritization