TypeOnline Course
Student Enrolled4
Price$550 / Rs. 27500
Buy NowBook Now
nck course performer

Admission Process

Admission Process

Sign in or create account at www.nckpharma.com with all details and make the course fees payment to start the course

Sign Up Now

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 80Consumer buying behavior
Lecture 81Product Life cycle - Basic Understanding
Lecture 82STP - Strategic Positioning and Brand Differentiation
Lecture 83Pricing Strategies
Lecture 84Distribution and Logistics
Lecture 85Pharmaceutical Distribution
Lecture 86Promotion Management Process in a Pharmaceutical Company
Lecture 87Setting and Quantifying Promotional Objectives
Lecture 88Promotional Budget Setting : Tools and Techniques
Lecture 89Basics of Advertising : Introduction
Lecture 90Classifications of Advertising
Lecture 91The Advertising agency
Lecture 92Classification of Doctors
Lecture 93Moving Annual Total (MAT)
Lecture 94CAGR
Lecture 95Brand Potential
Section 5Pharma Brand Strategy Management
Lecture 96PRATICAL TRAINING SESSION : BRAND NAME,  BRAND LOGO, TRADEMARKING 
Lecture 97Purpose of Pharma Brand Logo
Lecture 98Component of brand logo
Lecture 99Brand Name and TM Registration Process
Lecture 100How to design excellent brand logo?
Lecture 101Case study in brand name finalization
Lecture 102Brand Name Simulation
Lecture 103Traditional Vs. Non-Traditional trademark
Lecture 104Global Protection of the Pharma Brand
Lecture 105Rebranding in Pharmaceuticals
Lecture 106Brand Logo Development: Real Life Simulation
Lecture 107Fundamental of Pharma Marketing Plan 
Lecture 108Basic Know-How: Marketing Campaign Development 
Lecture 109How to prepare a Pharma Brand Plan 
Lecture 110Decide about brand USP -What to promote 
Lecture 111How to prepare promotogram. Download sample Promotogram
Lecture 112Sample Allocation 
Lecture 113Importance of Visual Aid in Pharmaceutical Industry
Lecture 114BUYING SIGNAL
Lecture 115Indications for Drugs: Approved vs. Non-approved 
Lecture 116Case Study : Indication approval to extend the usage of the brands (molecule) 
Lecture 117Step By Step Visual Aid Designing
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 123Visual Aid, Literature reference Sample
Lecture 124Creativity to develop brand essence
Lecture 125Increase the brand reach with advance segmentation
Lecture 126Concept of uniform branding for better brand acceptability
Lecture 127Concept of Brand Differentiation
Section 6Biopharmaceuticals and Biosimilar Development Process
Lecture 128Introduction : Biopharmaceuticals
Lecture 129Classification of Biopharmaceutical 
Lecture 130Introduction to Biosimilar
Lecture 131Chemical Drugs Vs. Biologic Drugs
Lecture 132Current Trends in Biopharmaceutical Market
Lecture 133Dynamics of Biopharmaceutical Market
Lecture 134Complexity of biopharma supply chain and operations
Lecture 135Biopharma - Market Segmentation
Lecture 136Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 137Recombinant protein
Lecture 138Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 139Monoclonal Antibodies
Lecture 140Synthetic Immunomodulators
Lecture 141Production of Monoclonal Antibodies
Lecture 142Cytokines
Lecture 143Interferon
Lecture 144Erythropoiesis-stimulating agent
Lecture 145Biological Licensing Application (BLA) 
Lecture 146Biosimilar Approval process
Lecture 147Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 148Pricing and cost effectiveness of biosimilars
Lecture 149Exclusivity Protections for Biopharmaceuticals
Lecture 150REMS Strategic Planning 
Lecture 151Review : 351(a) vs. 351(k) pathway
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 
Lecture 158Rx to OTC switch - case study
Section 8Advance Strategic Portfolio Management Skill Training
Lecture 159Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 160Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 161Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 162Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 163Numerical SWOT Practical training
Lecture 164Modelling 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 165Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 166Forecasting : Tools and Techniques
Lecture 167Market Sizing & Forecasting Case Study
Lecture 168Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 169Average Royalty Rates
Lecture 170Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 171Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 172Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 173Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 174SPECIAL PURPOSE VEHICLES (SPV)
Lecture 175Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 176Types of Deals from Discovery to Commercialization
Lecture 177Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 178Licensing Payment Scheduling: Different Types
Lecture 179Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 180Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 181Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 182Negotiation Skill Training for BD / Project / Strategic Management Professionals
Lecture 183Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 184Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 185Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 186Due Diligence Activities in Pharmaceutical Licensing
Section 9Final Certification Examination
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,