TypeOnline Course
DateNov 1, 2015
Student Enrolled7
Price$550 / Rs. 27500
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Admission Process

Admission Process

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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.
  • 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
  • Drug Registration overseas
  • International Marketing strategic planning in pharmaceutical
  • In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Codevelopment, comarketing deals
  • 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 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 38Black Box Warning
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
Section 2R&D to commercialization Strategic Management discovery [EU]
Lecture 46Introduction to EU Regulation 
Lecture 47Orientation to European Countries and National Regulatory Bodies
Lecture 48EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 49EMA and EMA Authorisation Process
Lecture 50EMA and EMA Authorisation Process
Lecture 51EU MA Application Types and Strategic Planning
Lecture 52EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 53EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 54Validity 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 55Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 56EU Orphan Medicinal Products Regulation
Lecture 57Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 58Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 59Summary of Product Characteristics 
Lecture 60Compassionate Use
Lecture 61MHRA - UK Regulation 
Lecture 62The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 63EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 64EU Prime Designation 
Lecture 65Accelerated assessment by EMEA
Lecture 66EU Adaptive Pathway
Lecture 67European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 68SPOR  - Concept of Master Data Management  
Section 3Intellectual Property Management
Lecture 69Patent and Trademark Office - How they work?
Lecture 70Patent
Lecture 71Application For Patent
Lecture 72Trademark
Lecture 73Steps Know How & Key Points - Patent Application 
Lecture 74Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Pharma Marketing - Brand Management
Lecture 75Introduction to Pharma Marketing
Lecture 76Market Research in Pharma Business
Lecture 77Consumer buying behavior
Lecture 78Product Life cycle - Basic Understanding
Lecture 79STP - Strategic Positioning and Brand Differentiation
Lecture 80Pricing Strategies
Lecture 81Distribution and Logistics
Lecture 82Pharmaceutical Distribution
Lecture 83Promotion Management Process in a Pharmaceutical Company
Lecture 84Setting and Quantifying Promotional Objectives
Lecture 85Promotional Budget Setting : Tools and Techniques
Lecture 86Basics of Advertising : Introduction
Lecture 87Classifications of Advertising
Lecture 88The Advertising agency
Lecture 89Classification of Doctors
Lecture 90Moving Annual Total (MAT)
Lecture 91CAGR
Lecture 92Brand Potential
Section 5Pharma Brand Strategy Management
Lecture 93PRATICAL TRAINING SESSION : BRAND NAME,  BRAND LOGO, TRADEMARKING 
Lecture 94Purpose of Pharma Brand Logo
Lecture 95Component of brand logo
Lecture 96Brand Name and TM Registration Process
Lecture 97How to design excellent brand logo?
Lecture 98Case study in brand name finalization
Lecture 99Brand Name Simulation
Lecture 100Traditional Vs. Non-Traditional trademark
Lecture 101Global Protection of the Pharma Brand
Lecture 102Rebranding in Pharmaceuticals
Lecture 103Brand Logo Development: Real Life Simulation
Lecture 104Fundamental of Pharma Marketing Plan 
Lecture 105Basic Know-How: Marketing Campaign Development 
Lecture 106How to prepare a Pharma Brand Plan 
Lecture 107Decide about brand USP -What to promote 
Lecture 108How to prepare promotogram. Download sample Promotogram
Lecture 109Sample Allocation 
Lecture 110Importance of Visual Aid in Pharmaceutical Industry
Lecture 111BUYING SIGNAL
Lecture 112Indications for Drugs: Approved vs. Non-approved 
Lecture 113Case Study : Indication approval to extend the usage of the brands (molecule) 
Lecture 114Step By Step Visual Aid Designing
Lecture 115Guideline of Visual Aid Designin
Lecture 116Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 117VISUAL AID PRINTING 
Lecture 118Detailing and e-detailing
Lecture 119Marketing Plan followed by Visual Aid Development
Lecture 120Visual Aid, Literature reference Sample
Lecture 121Creativity to develop brand essence
Lecture 122Increase the brand reach with advance segmentation
Lecture 123Concept of uniform branding for better brand acceptability
Lecture 124Concept of Brand Differentiation
Section 6Biopharmaceuticals and Biosimilar Development Process
Lecture 125Introduction : Biopharmaceuticals
Lecture 126Classification of Biopharmaceutical 
Lecture 127Introduction to Biosimilar
Lecture 128Chemical Drugs Vs. Biologic Drugs
Lecture 129Current Trends in Biopharmaceutical Market
Lecture 130Dynamics of Biopharmaceutical Market
Lecture 131Complexity of biopharma supply chain and operations
Lecture 132Biopharma - Market Segmentation
Lecture 133Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 134Recombinant protein
Lecture 135Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 136Monoclonal Antibodies
Lecture 137Synthetic Immunomodulators
Lecture 138Production of Monoclonal Antibodies
Lecture 139Cytokines
Lecture 140Interferon
Lecture 141Erythropoiesis-stimulating agent
Lecture 142Biological Licensing Application (BLA) 
Lecture 143Biosimilar Approval process
Lecture 144Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 145Pricing and cost effectiveness of biosimilars
Lecture 146Exclusivity Protections for Biopharmaceuticals
Lecture 147REMS Strategic Planning 
Lecture 148Review : 351(a) vs. 351(k) pathway
Section 7Advance Portfolio Management
Lecture 149Co-promotion & Co-marketing strategy
Lecture 150Reverse co-promotion
Lecture 151New Indication Approval Process and Promotion
Lecture 152Publication Management for strategic positioning of the brands
Lecture 153Juxtapid Case Study
Lecture 154OTC Switch 
Lecture 155Rx to OTC switch - case study
Section 8Strategic Orientation in Pharma and Biopharma industry
Lecture 156Licensing Vs. Outlicensing in Pharma / Biopharma Industry
Lecture 157Licensing - Advance Strategic Learning
Lecture 158Terms / Duration of License
Lecture 159Are improvements licensed
Lecture 160Financial of Licensing Deals
Lecture 161Milestone Payment
Lecture 162How are royalties structured in a licensing deal?
Lecture 163What accounts, inspection and audit provisions are in a license?
Lecture 164How is patenting dealt with in a license?
Lecture 165What warranties are in a license?
Lecture 166What competition law issues are there in licensing?
Lecture 167Co-development and co-marketing agreements in Pharmaceutical Strategic Management
Lecture 168Due Diligence Activities in Pharmaceutical Licensing
Lecture 169Detailed in-depth strategic understanding on Technology Transfer
Lecture 170Overview of contractual agreements in Technology Transfer
Lecture 171Confidentiality agreements
Lecture 172Material Transfer Agreements
Lecture 173Deeds of assignment or assignment deeds
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