TypeOnline Course
Student Enrolled7
Price$550 / Rs. 27500
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Admission Process

Admission Process

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Core Learning Area



Course Title: KPE’s Advance Diploma in Pharmaceutical Strategic Business Management [ADPSM]

Course Objective: The online certificate course in Pharmaceutical strategic management is conceptualized with objective to impart knowledge and understanding of the Pharmaceutical Strategic Business Management from the 360 degree from the different areas of  Pharmaceutical businesses like drug discovery-to-commercialization, portfolio management, business development, brand management.

1 Year.

Key Learning Area for the course

  • Drug Development to Commercialization – R&D management and related strategic planning
  • Innovation Management in pharmaceutical industry. In depth understanding of the intellectual property management in Pharmaceutical and Biopharmaceutical Industry
  • Pharmaceutical and Biopharmaceutical industry understanding.
  • Exclusive training on Biopharmaceutical and biosimilar management
  • Pharma Marketing and branding Strategic Planning
  • Generic Drug Strategic Planning
  • Managing pharmaceutical SBU revenue model
  • Drug Registration overseas
  • International Marketing strategic planning in pharmaceutical
  • In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing
  • Financial Planning and Management for pharma strategic management professionals
  • Life cycle extension / Loss of Exclusivity – LOE strategies

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

2. Simulation to real life Strategic Management.

3. Access to Industry Databank – 300 Strategic Management examples etc.

4. Access to Pharmaceutical Case Studies

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

Minimum qualification Graduation in any discipline with more than 24 months of work experience in Pharmaceutical  domain. Work Experience is mentioned is mandatory for admission into this course.

Course Flow

Section 1Introduction to Pharmaceutical Strategic Management
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
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 7Strategic management – Strategic decision making – business level sub strategies
Lecture 8Expedited Drug Development Program
Lecture 9Practical Training on INDA, NDA, ANDA filing
Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 11Authorized Generics: Key Understanding
Lecture 12Exploratory IND Vs. Traditional IND
Lecture 13Patents Vs. exclusivity 
Lecture 14Strategic Learning from New Drug Development
Lecture 15Orphan Drug Designation 
Lecture 16Advance Strategic Learning on 505B2 Pathway
Lecture 17Chemistry, Manufacturing & Controls 
Lecture 18Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Research - Pharma R&D Strategic Orientation
Lecture 19Clinical Trial Terminologies
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent 
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Intellectual Property Management
Lecture 24Patent and Trademark Office - How they work?
Lecture 25Patent
Lecture 26Application For Patent
Lecture 27Trademark
Lecture 28Steps Know How & Key Points - Patent Application 
Lecture 29Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Pharma Marketing - Brand Management
Lecture 30Introduction to Pharma Marketing
Lecture 31Market Research in Pharma Business
Lecture 32Consumer buying behavior
Lecture 33Product Life cycle - Basic Understanding
Lecture 34STP - Strategic Positioning and Brand Differentiation
Lecture 35Pricing Strategies
Lecture 36Distribution and Logistics
Lecture 37Pharmaceutical Distribution
Lecture 38Promotion Management Process in a Pharmaceutical Company
Lecture 39Setting and Quantifying Promotional Objectives
Lecture 40Promotional Budget Setting : Tools and Techniques
Lecture 41Basics of Advertising : Introduction
Lecture 42Classifications of Advertising
Lecture 43The Advertising agency
Lecture 44Classification of Doctors
Lecture 45Moving Annual Total (MAT)
Lecture 46CAGR
Lecture 47Brand Potential
Section 5Pharma Brand Strategy Management
Lecture 49Purpose of Pharma Brand Logo
Lecture 50Component of brand logo
Lecture 51Brand Name and TM Registration Process
Lecture 52How to design excellent brand logo?
Lecture 53Case study in brand name finalization
Lecture 54Brand Name Simulation
Lecture 55Traditional Vs. Non-Traditional trademark
Lecture 56Global Protection of the Pharma Brand
Lecture 57Rebranding in Pharmaceuticals
Lecture 58Brand Logo Development: Real Life Simulation
Lecture 59Fundamental of Pharma Marketing Plan 
Lecture 60Basic Know-How: Marketing Campaign Development 
Lecture 61How to prepare a Pharma Brand Plan 
Lecture 62Decide about brand USP -What to promote 
Lecture 63How to prepare promotogram. Download sample Promotogram
Lecture 64Sample Allocation 
Lecture 65Importance of Visual Aid in Pharmaceutical Industry
Lecture 67Indications for Drugs: Approved vs. Non-approved 
Lecture 68Case Study : Indication approval to extend the usage of the brands (molecule) 
Lecture 69Step By Step Visual Aid Designing
Lecture 70Guideline of Visual Aid Designin
Lecture 71Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 73Detailing and e-detailing
Lecture 74Marketing Plan followed by Visual Aid Development
Lecture 75Visual Aid, Literature reference Sample
Lecture 76Creativity to develop brand essence
Lecture 77Increase the brand reach with advance segmentation
Lecture 78Concept of uniform branding for better brand acceptability
Lecture 79Concept of Brand Differentiation
Section 6Biopharmaceuticals and Biosimilar Development Process
Lecture 80Introduction : Biopharmaceuticals
Lecture 81Classification of Biopharmaceutical 
Lecture 82Introduction to Biosimilar
Lecture 83Chemical Drugs Vs. Biologic Drugs
Lecture 84Current Trends in Biopharmaceutical Market
Lecture 85Dynamics of Biopharmaceutical Market
Lecture 86Complexity of biopharma supply chain and operations
Lecture 87Biopharma - Market Segmentation
Lecture 88Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 89Recombinant protein
Lecture 90Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 91Monoclonal Antibodies
Lecture 92Synthetic Immunomodulators
Lecture 93Production of Monoclonal Antibodies
Lecture 94Cytokines
Lecture 95Interferon
Lecture 96Erythropoiesis-stimulating agent
Lecture 97Biological Licensing Application (BLA) 
Lecture 98Biosimilar Approval process
Lecture 99Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 100Pricing and cost effectiveness of biosimilars
Lecture 101Exclusivity Protections for Biopharmaceuticals
Lecture 102REMS Strategic Planning 
Lecture 103Review : 351(a) vs. 351(k) pathway
Section 7Stretgic Planning in Pharmaceuticals & Biopharmaceuticals
Lecture 104Strategies in different phases of Clinical Trial
Lecture 105Lifecycle Extension Strategies - Evergreening
Lecture 106Advance Study in Para IV filing
Lecture 107Evergreening - Patent Life Extension Strategies
Lecture 108Pay For Delay Strategy
Lecture 109Compulsory Licensing
Lecture 110In-Licensing Vs. Outlicensing
Lecture 111LOE Strategies for Innovator Brands with case study
Lecture 112Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 113Drug Repurposing
Section 8Advance Portfolio Management
Lecture 114Advance understanding of the portfolio Management 
Lecture 115Co-promotion & Co-marketing strategy
Lecture 116Reverse co-promotion
Lecture 117New Indication Approval Process and Promotion
Lecture 118Publication Management for strategic positioning of the brands
Lecture 119Juxtapid Case Study
Lecture 120OTC Switch 
Lecture 121Rx to OTC switch - case study
Section 9Strategic Orientation in Pharma and Biopharma industry
Lecture 122Licensing Vs. Outlicensing in Pharma / Biopharma Industry
Lecture 123Licensing - Advance Strategic Learning
Lecture 124Terms / Duration of License
Lecture 125Are improvements licensed
Lecture 126Financial of Licensing Deals
Lecture 127Milestone Payment
Lecture 128How are royalties structured in a licensing deal?
Lecture 129What accounts, inspection and audit provisions are in a license?
Lecture 130How is patenting dealt with in a license?
Lecture 131What warranties are in a license?
Lecture 132What competition law issues are there in licensing?
Lecture 133Co-development and co-marketing agreements in Pharmaceutical Strategic Management
Lecture 134Due Diligence Activities in Pharmaceutical Licensing
Lecture 135Detailed in-depth strategic understanding on Technology Transfer
Lecture 136Overview of contractual agreements in Technology Transfer
Lecture 137Confidentiality agreements
Lecture 138Material Transfer Agreements
Lecture 139Deeds of assignment or assignment deeds
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