TypeOnline Course
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Price$550 / Rs. 27500
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pharma strategic management course

Introduction

Duration

Core Learning Area

Features

Eligibility

Course Code: KPE-C-008

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.
  • Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
  • Objective – Strategy – Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques – Web Search | Conference | Confidentiality – CDA | MTA
  • Life cycle extension / Loss of Exclusivity – LOE strategies.
  • Pharma Marketing and branding Strategic Planning.pharma strategic management
  • Generic Drug Strategic Planning
  • Strategic Pathways for marketing authorization of the pharmaceutical and – biopharmaceutical products in various business regions – US, EU, LATAM, GCC, rest of the world.
  • Exclusive training on Biopharmaceutical and biosimilar management.
  • In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion,
  • Financial Planning and Management for pharma strategic management professionals
  • Modelling and Deal Valuation – Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
  • Royalty Management – Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking – Concept and Calculation | Minimum Annual Royalties | Reach through royalties
  • Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
  • Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
  • Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales – Max-Min Approach.
  • EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

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 1R&D to commercialization Strategic Management discovery [US]
Lecture 1Drug Discovery, Development Process
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 7Orange Book
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
Lecture 19Clinical Trials fundamental and Terminologies 
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent 
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24FDA Forms and How to fill the resources
Lecture 25Importance and Significance of Phase 2b Clinical Trial 
Lecture 26Regulatory Strategies in different phases of Clinical Trial
Lecture 27Advance study on Para IV Filing
Lecture 28Para IV Notices
Lecture 29Evergreening - Patent Life Extension Strategies
Lecture 30Pay For Delay Strategy
Lecture 31REMS Strategic Planning 
Lecture 32Compulsory Licensing
Lecture 33Licensing & Technology Transfer
Lecture 34In-Licensing Vs. Outlicensing
Lecture 35LOE Strategies for Innovator Brands with case study
Lecture 36Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 37Drug Repurposing
Lecture 38Licensing - Advance Learning 
Lecture 39Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 40NCE Vs. 505b2 application - Case Based Learning 
Lecture 41FTF - 180 Days Exclusivity - Case Based Learning
Lecture 42Classic case study of the 505b2 filing : Case Based Learning
Lecture 43Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 44Advance Training on effective management of Establishment Inspection Report | 483 Observations | USFDA Warning Letter | FDA inspection | Closing of Warning Letter 
Lecture 45Data Integrity issues in Pharmaceutical Industry
Lecture 46What is meaning of 'Pipeline in a Molecule'?
Lecture 47Emergency Use Authorization : Case Based Learning
Lecture 48Patent Cliff | Sales Forecast Formulae after patent expiry
Section 2R&D to commercialization Strategic Management discovery [EU]
Lecture 49Introduction to EU Regulation 
Lecture 50Orientation to European Countries and National Regulatory Bodies
Lecture 51EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 52EMA and EMA Authorisation Process
Lecture 53EMA and EMA Authorisation Process
Lecture 54EU MA Application Types and Strategic Planning
Lecture 55EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 56EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 57Validity 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 58Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 59EU Orphan Medicinal Products Regulation
Lecture 60Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 61Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 62Summary of Product Characteristics 
Lecture 63Compassionate Use
Lecture 64MHRA - UK Regulation 
Lecture 65The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 66EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 67EU Prime Designation 
Lecture 68Accelerated assessment by EMEA
Lecture 69EU Adaptive Pathway
Lecture 70European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 71SPOR  - Concept of Master Data Management  
Section 3Intellectual Property Management
Lecture 72Patent and Trademark Office - How they work?
Lecture 73Patent
Lecture 74Application For Patent
Lecture 75Trademark
Lecture 76Steps Know How & Key Points - Patent Application 
Lecture 77Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Pharma Marketing - Brand Management
Lecture 78Introduction to Pharma Marketing
Lecture 79Market Research in Pharma Business
Lecture 80Product Life cycle 
Lecture 81Advance - Strategic Planning in Product Life cycle Management
Lecture 82Segmentation, Targeting and Positioning
Lecture 83Pricing Strategies
Lecture 84A Pharmaceutical Segmentation outlook
Lecture 85Distribution Channel in Pharmaceutical Industry 
Lecture 86Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 87Setting and Quantifying Promotional Objectives
Lecture 88Promotional Budget Setting : Tools and Techniques
Lecture 89Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 90Method of Promotional Budgeting
Lecture 91Basics of Advertising : Introduction
Lecture 92The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 93Moving Annual Total (MAT)
Lecture 94CAGR
Lecture 95Brand Potential
Lecture 96Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 97Advertising Planning - ATL, BTL, TTL activities
Lecture 98Target Audiences for Pharma Promotion : Types and Specialization
Lecture 99Business segments of Pharmaceutical Companies
Lecture 100Target Audience Selection Based on Products
Section 5Pharma Brand Strategy Management
Lecture 101PRATICAL TRAINING SESSION : BRAND NAME,  BRAND LOGO, TRADEMARKING 
Lecture 102Purpose of Pharma Brand Logo
Lecture 103Component of brand logo
Lecture 104Brand Name and TM Registration Process
Lecture 105How to design excellent brand logo?
Lecture 106Case study in brand name finalization
Lecture 107Brand Name Simulation
Lecture 108Traditional Vs. Non-Traditional trademark
Lecture 109Global Protection of the Pharma Brand
Lecture 110Rebranding in Pharmaceuticals
Lecture 111Brand Logo Development: Real Life Simulation
Lecture 112Fundamental of Pharma Marketing Plan 
Lecture 113Basic Know-How: Marketing Campaign Development 
Lecture 114How to prepare a Pharma Brand Plan 
Lecture 115Decide about brand USP -What to promote 
Lecture 116How to prepare promotogram. Download sample Promotogram
Lecture 117Indications for Drugs: Approved vs. Non-approved 
Lecture 118Guideline of Visual Aid Designin
Lecture 119Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 120VISUAL AID PRINTING 
Lecture 121Detailing and e-detailing
Lecture 122Marketing Plan followed by Visual Aid Development
Lecture 123Creativity to develop brand essence
Lecture 124Increase the brand reach with advance segmentation
Lecture 125Concept of uniform branding for better brand acceptability
Lecture 126Concept of Brand Differentiation
Section 6Biopharmaceuticals and Biosimilar Development Process
Lecture 127Introduction : Biopharmaceuticals
Lecture 128Classification of Biopharmaceutical 
Lecture 129Introduction to Biosimilar
Lecture 130Chemical Drugs Vs. Biologic Drugs
Lecture 131Current Trends in Biopharmaceutical Market
Lecture 132Dynamics of Biopharmaceutical Market
Lecture 133Complexity of biopharma supply chain and operations
Lecture 134Biopharma - Market Segmentation
Lecture 135Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 136Recombinant protein
Lecture 137Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 138Monoclonal Antibodies
Lecture 139Synthetic Immunomodulators
Lecture 140Production of Monoclonal Antibodies
Lecture 141Cytokines
Lecture 142Interferon
Lecture 143Erythropoiesis-stimulating agent
Lecture 144Biological Licensing Application (BLA) 
Lecture 145Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 146Exclusivity Protections for Biopharmaceuticals
Lecture 147REMS Strategic Planning 
Lecture 148Biosimilar Development Process
Lecture 149Strategic Consideration for Biosimilar Development 
Lecture 150Bio-Manufacturing Process Information
Lecture 151Studies required for approval of biosimilar
Section 7Advance Portfolio Management
Lecture 152Co-promotion & Co-marketing strategy
Lecture 153Reverse co-promotion
Lecture 154New Indication Approval Process and Promotion
Lecture 155Publication Management for strategic positioning of the brands
Lecture 156Juxtapid Case Study
Lecture 157OTC Switch 
Section 8Advance Strategic Portfolio Management Skill Training
Lecture 158Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 159Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 160Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 161Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 162Numerical SWOT Practical training
Lecture 163Modelling and Deal Valuation - Top Down Modeal | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 164Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 165Forecasting : Tools and Techniques
Lecture 166Market Sizing & Forecasting Case Study
Lecture 167Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 168Average Royalty Rates
Lecture 169Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 170Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 171Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 172Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 173SPECIAL PURPOSE VEHICLES (SPV)
Lecture 174Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 175Types of Deals from Discovery to Commercialization
Lecture 176Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 177Licensing Payment Scheduling: Different Types
Lecture 178Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 179Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 180Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 181Negotiation Skill Training for BD / Project / Strategic Management Professionals
Lecture 182Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 183Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 184Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 185Due Diligence Activities in Pharmaceutical Licensing
Section 9Final Certification Examination
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