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pharma global business

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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  in the form of printable e-book will be available for download. All books can be downloaded by visiting your dashboard.
  • Immediately upon admission, course participant will be provided with user id and password to access his/her personalized web page through which he can access e-lectures, cases studies, etc. across from anywhere using internet.

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  • 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 certification course.
  • There will be no fees  for add on courses and courses can be opted any time during the Global Business Course access period.
  • On completion of add on course, participant will be issuing course certificate.

 

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) Filing
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 10USFDA expedited programs
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 16Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 17Orphan Drug & Orphan Drug Act
Lecture 18Clinical Research : Detailed Understanding
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent 
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Section 2Innovation Management in Pharmaceutical & Biopharmaceutical Industry
Lecture 26USPTO - Introduction
Lecture 27Patent
Lecture 28Patent - Practical on search and filing - USPTO
Lecture 29Trademark - Practical on TM Search & Registration Process - USPTO
Lecture 30Trademark - Practical on TM Search USPTO
Lecture 31Trademark Search assignment USPTO
Lecture 32Patent - Practical on search and filing in Indian Patent Office
Lecture 33Trademark - Practical on TM Search & Registration Process in India
Lecture 34Trademark Search assignment (India)
Lecture 35Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 3Advance Strategic Management
Lecture 36Understanding of Regulatory Strategies
Lecture 37Advance study on Para IV Filing
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Drug Repurposing
Lecture 40Pay For Delay Strategy
Lecture 41Pediatric Exclusivity - Case Study
Lecture 42Compulsory Licensing
Lecture 43Technology Licensing
Lecture 44Drug Pipeline and In / Outlicensing
Section 4Basic Fundamental of Pharma Production & Plant Management
Lecture 45Definition of GMP
Lecture 46Introduction to Good Manufacturing Practices
Lecture 47Premises & Plant Layout Designing
Lecture 48Sanitation and Hygiene
Lecture 49Equipment Modules
Lecture 50Production Modules
Lecture 51Documentation
Lecture 52Quality Control
Lecture 53G7 Lecture Product Complaint
Lecture 54G8 Lecture Storage Module
Lecture 55ISO and ISO Audits
Lecture 56Pharmaceutical SOPs Management from regulatory perspective
Lecture 57SOP Automation in Pharmaceutical Industry
Lecture 58USFDA warning Letter & CAPA
Lecture 59USFDA Warning Letter
Lecture 60Handling of warning letter
Lecture 61Case Study - Warning Letter
Lecture 62Detailed Understanding of DMF & SMF
Section 5Global Business : European Union - Regulatory & Strategic Planning
Lecture 63Introduction to EU Regulation 
Lecture 64Orientation to European Countries and National Regulatory Bodies
Lecture 65Orientation to European Countries and National Regulatory Bodies
Lecture 66Overview of EU Regulation
Lecture 67EMA and EMA Authorisation Process
Lecture 68Summary of Product Characteristics
Lecture 69Compassionate Use
Lecture 70EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 71Validity 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 72Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 73EU Orphan Medicinal Products Regulation
Lecture 74Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 75Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 76Summary of Product Characteristics 
Lecture 77Compassionate Use
Lecture 78MHRA - UK Regulation 
Lecture 79The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 80EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 81EU Prime Designation 
Lecture 82Accelerated assessment by EMEA
Lecture 83EU Adaptive Pathway
Lecture 84European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 85SPOR  - Concept of Master Data Management  
Section 6Global Business : GCC countries
Lecture 86GCC Pharma Market
Lecture 87GCC Export – Local Partner
Lecture 88GCC Registration Procedure
Lecture 89Drug Registration in Saudi Arabia
Lecture 90Documentation Required for the GCC countries
Lecture 91Drug Registration in GCC countries
Lecture 92Medical Device Regulation in GCC countries
Section 7Drug Registration Dossier
Lecture 93Introduction to Common Technical Document (CTD)
Lecture 94Asean Common Technical Document (ACTD)
Lecture 95Introduction to Electronic Common Technical Document (ECTD)
Lecture 96Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 97Modules on Stability Study 1
Section 8Global Business : ASEAN countries
Lecture 98ASEAN Drug Regulatory Affairs
Lecture 99Asean Geography
Lecture 100Drug Registration in Brunei
Lecture 101Drug Registration in Malaysia
Lecture 102Drug Registration in Cambodia
Lecture 103Drug Registration in Mayanmar
Lecture 104Drug Registration in Philippines
Lecture 105Drug Registration in Singapore
Section 9Pharmaceutical Business in India
Lecture 106Drug Regulation in India - CDSCO
Lecture 107National Pharmaceutical Pricing Authority
Lecture 108Drug Price Regulation in India
Lecture 109Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 110Drug Price Control Order 2013
Lecture 111Case Study of New Drug Approval in India
Section 10Introduction to Pharma Product Management
Lecture 112Introduction to Pharma Product Management
Lecture 113Detailed Understanding of Product Management Job
Section 11Marketing Orientation for Product Manager
Lecture 114Marketing Orientation for Product Manager
Lecture 115Why Is Market Research Important in Pharmaceutical Business?
Lecture 116Consumer buying behavior
Lecture 117Consumer buying behavior
Lecture 118Segmentation
Lecture 119Pricing
Lecture 120Distribution and Logistics
Lecture 121Segmentation, Targeting and Positioning
Lecture 122A Pharmaceutical Segmentation outlook
Lecture 123Place / Distribution
Lecture 124Promotion Management Process
Lecture 125Setting and Quantifying Promotional Objectives
Lecture 126Break even analysis
Lecture 127Basics of Advertising : Introduction
Lecture 128Classifications of Advertising
Lecture 129The Advertising agency
Section 12Practical Training on Pharma Brand Logo Development
Lecture 130Brand Logo - Introduction
Lecture 131Purpose of Brand Logo
Lecture 132Component of Brand Logo
Lecture 133Trademark Registration
Lecture 134Trademark - Practical on TM Search
Lecture 135Trademark Search assignment
Lecture 136How to design excellent brand logo?
Lecture 137How to design excellent brand logo?
Lecture 138Color Systems - RGB & CMYK
Lecture 139Few Case Studies related to brand names and logos
Lecture 140Brand Logo - Simulation
Lecture 141Colour Trademarking in Pharma Branding
Lecture 142How to protect pharma brands globally?
Lecture 143Rebranding in Pharmaceuticals
Lecture 144Brand Logo Development: Real Life Simulation
Section 13Advance Pharma Brand Management - 1
Lecture 145 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 146Marketing Campaign Development
Lecture 147How to prepare a Pharma Brand Plan
Lecture 148Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 149Decide about brand USP -What to promote
Lecture 150How to prepare promotogram. Download sample Promotogram
Lecture 151Importance and Handling of Cycle Meeting and its importance
Lecture 152Sample Marketing Plan : Febuxostat
Lecture 153Sample Marketing Plan : Orlistat
Lecture 154New Product Launch Case Study
Lecture 155Brand Launch Case Study
Lecture 156Aristada - Launch Case Study
Lecture 157CSR Campaign
Lecture 158Cost Based Working for Sample Allocation
Section 14Advance Pharma Brand Management - 2
Lecture 159Importance of Visual Aid in Pharmaceutical Industry
Lecture 160Fundamentals of preparing visual aid
Lecture 161Indications for Drugs: Approved vs. Non-approved
Lecture 162Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 163Step by step visual aid development process
Lecture 164 Guideline of Visual Aid Designing
Lecture 165Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 166VISUAL AID PRINTING
Lecture 167Detailing and e-detailing
Lecture 168Visual Aid Development Process Review
Lecture 169Visual Aid, Literature reference Sample
Lecture 170Tablet vs. Conventional Detailing
Lecture 171Celebrity Endorsement in Pharmaceuticals
Lecture 172Conference Management
Section 15Practical Training on Packaging Development
Lecture 173Artwork Development Process in PMT Department
Lecture 174Product List and Reminder card development
Lecture 175Catch Cover Development
Lecture 176Packaging Development
Lecture 177Prescribing Information and Patient Information Leaflet development
Lecture 178Pharma Packaging Case Studies
Section 16Analytics
Lecture 179Moving annual total (MAT)
Lecture 180Compound Annual Growth Rate (CAGR)
Lecture 181Analytical Approach in Determining Brand Potential with case study
Section 17Advance Strategic Management
Lecture 182Co-promotion & Co-marketing strategy in pharma industry
Lecture 183Concept of Reverse co-promotion in pharma industry
Lecture 184In-Licensing Vs. Outlicensing
Lecture 185Importance of Publications in Pharmaceutical Industry
Lecture 186Juxtapid Case Study
Lecture 187New Indication Approval Process and Promotion
Section 18Fundamental understanding in Finance
Section 19Access to Case study directory
Section 20Project & Portfolio Management
Lecture 190Introduction: Project Management
Lecture 191Difference between Project and Program
Lecture 192Program/Project Leadership versus Stage
Lecture 193Project Management Constraint
Lecture 194Key to Project Success
Lecture 195PERT, CPM, Critical Path, Project Diagram and its components
Lecture 196Qualities of a Good Project Leader
Lecture 197Qualities of a Good Team Representative
Lecture 198Project Tracking in Drug Discovery Projects
Lecture 199Project Benchmarking through a Consortium
Lecture 200Cycle Times (Stage or phase lengths)
Lecture 201he proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 202What is a milestone chart?
Lecture 203Project Termination and Project Reinitiation
Lecture 204Asset Tracking
Lecture 205Levels of Project and Portfolio Management
Lecture 206Functions of Portfolio Management Team
Lecture 207Importance of Periodic Portfolio Reviews
Lecture 208Portfolio Prioritization