InstructorRoyed Training
TypeOnline Course
Price$790 USD / 39500 INR.
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Pharma Strategic Management course

Introduction

Learning Areas

Features

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About strategic management

pharma strategic management course

This online training provide understanding of pharma strategic business management skills which are commonly applied in the pharma and biotech companies. The course is designed to create the new-edged Strategic Business Manager for pharma and biotech industry. Course focuses on how pharma and biotech strategic business manager works and their key responsibilities and job functions.

  • Course Code: RYD-005
  • Title of the course: PG Certification in Pharma Strategic Management
  • Nature of the course: Online Self Paced Learning
  • Duration: 1 Year
  • Certification: Certificate will be provided at the end of the successful completion of the course.

Key Learning Area for the course

  • Drug Development to Commercialization. R&D Fundamentals.
  • Pharmacoeconomics / Health Economics.
  • Clinical research, real world data and real world evidence.
  • Market Access strategic planning.
  • Pricing, Reimbursement.
  • Forecasting.
  • Portfolio Management.
  • Pharma Marketing Strategic Planning.
  • Generic Drug Strategic Planning.
  • Biologic and Biosimilar Strategic Planning.
  • Managing pharmaceutical SBU (strategic business unit) revenue model.
  • Region specific pharma business strategies.
  • Inlicensing and outlicensing.
  • Deals and deal management in pharmaceutical and bio pharmaceutical industry.
  • Deal valuation tools and techniques.
  • Pharmaceutical Business Audit – Due diligence.
  • Financial Planning and Management for pharma strategic management professionals.
  • Branding Training – Brand plan preparation, advertisement management, marketing campaign planning.
  • Understanding on pharma strategic business management principles involved from drug discovery development to commercialization. Therefore fundamental to advance R&D management process training is included.
  • Additionally, the course provide pharma portfolio management skill training.
  • Advance Simulation provide to real life learning experience. Hence it helps to improve the decision making skills of the participants.
  • Biotech, biosimilar products strategic management is also part of the course.
  • Above all, course participants are exposed to Global Pharma Business Case Studies.
  • 24×7 access of the course. Hence you can attend the course at your own preferred date and time.

Related courses

What is strategic management in pharma and biotech industry?

  • Strategic management is the process of planning, monitoring, analysis and assessment of all what is must for an organization to meet its goals and objectives. Because of this, in all leading pharma and biotech companies, there is a separate division called strategic management cell. They work on planning organization’s strategy.
  • Pharma strategic management professionals involve in changes in organization’s business process. As a result, they bring the success to organization.
  • Today pharma and biotech organization are looking for trained professionals who understand all aspects of strategic planning. However, there is a lack of professionals who understand complex pharma and biotech business environment.

What skill Pharma Strategic Manager should have?

Firstly, Pharma Strategic Manager should be master of the drug discovery, development to commercialization process. They should have excellent and updated regulatory knowledge. Secondly, professionals should have the fundamental understanding on portfolio management process. Thirdly, they should have strategic business skills, acumen and competency. Last but not the least, they should have basic financial management skills. Most importantly, the course covers deal valuation tools and techniques.

To summarize, strategic management professionals should have overall pharma business functional understanding.

Do the course cover both pharmaceutical and biopharmaceutical strategic management?

  • Yes. It’s cover the both pharmaceutical and biopharmaceutical industry.

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Section 1R&D Fundamental | Discovery Development to Commercialization
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 7Handling of orange book
Lecture 8USFDA expedited programs
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 14Orphan Drug Designation 
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16Chemistry, Manufacturing & Controls 
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 18Introduction to Health Economics | Key terminologies related to health economics
Lecture 19HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 20ntroduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis 
Lecture 21Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty 
Lecture 22Core fundamentals of Health Economics | Clinical and economic burden | Public Health Care Payer Vs. Patient and Societal | Positioning a new treatment with the current treatment | QALY | ICER | Threshold value | Clinical trials vs health economics assessment
Lecture 23QALY | How to calculate QALY | Importance and Significance 
Lecture 24ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Lecture 25Pharmacoeconomic Evaluation Checklist | Health Economics Map | Economic evaluation cycle | Checklist of economic evaluation | Costs and Outcome relevant to different groups | Comparators | Problem of choosing the comparators
Lecture 26Pharmacoeconomic Evaluation - Resource and Cost | Fixed, Variable and Total Cost | Calculation | Average vs. marginal cost | Importance of marginal cost | Discounting | Discounting calculation | Preferable discounting rate | Sources of unit cost data | Reference costs
Lecture 27Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATP
Lecture 28Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model 
Lecture 29CER and PCOR
Section 2CLINICAL RESEARCH - PHARMA R&D STRATEGIC ORIENTATION
Lecture 30Clinical Trial Terminologies
Lecture 31Clinical Trial Protocol Writing
Lecture 32Ethics in Clinical Research
Lecture 33Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 34Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 35FDA Forms and How to fill the resources
Lecture 36Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 37Importance and Significance of Phase 2b Clinical Trial 
Lecture 38Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 39RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 40RWD and RWE - Fit to use | Assessment 
Lecture 41RWD data sources | Different types | Detailed understanding of each class 
Section 3Portfolio Management, Market Access. Pricing, Forecasting
Lecture 42Regulatory Strategies in different phases of Clinical Trial
Lecture 43Para IV Filing
Lecture 44Para IV Notices
Lecture 45Evergreening - Patent Life Extension Strategies
Lecture 46Pay For Delay Strategy
Lecture 47REMS Strategic Planning 
Lecture 48Compulsory Licensing
Lecture 49Licensing & Technology Transfer
Lecture 50In-Licensing Vs. Outlicensing
Lecture 51LOE Strategies for Innovator Brands with case study
Lecture 52Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 53Drug Repurposing
Lecture 54Advance understanding of the portfolio Management 
Lecture 55New Indication Approval Process and Promotion 
Lecture 56OTC Switch 
Lecture 57Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 58NCE Vs. 505b2 application - Case Based Learning 
Lecture 59FTF - 180 Days Exclusivity - Case Based Learning
Lecture 60Classic case study of the 505b2 filing : Case Based Learning
Lecture 61Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 62Pipeline in a Molecule
Lecture 63USFDA Emergency Use Authorization (EUA)
Lecture 64Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 65Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 66Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 67Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 68Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 69Indication Prioritization Case Study
Lecture 70Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 71AMCP Market Access Dossier Preparation 
Lecture 72Drug Pricing Methodologies
Lecture 73Drug Pricing Methodologies
Lecture 74Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 75Pharma Market Access Pricing Case Study : Lantus interchangeable Pricing 
Lecture 76Sales Forecasting in Life Science Industry
Lecture 77New Product Forecast Algorithm
Lecture 78Patient Based Forecasting Model | Applying more filters and variables
Lecture 79Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 80Prevalence Vs. Incidence Model
Lecture 81EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 82Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 83Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 84Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 85Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 86Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 87Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 88Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 89Simulation on Bottom-up forecasting
Lecture 90Assessment on Bottom-up forecasting
Lecture 91Oncology Brand Forecasting
Lecture 92Revenue Forecasting Case Study - Novel Antihypertensive 
Lecture 93Portfolio Based Forecasting | Forecasting Model Development in Excel 
Section 4Pharma Marketing and Brand Management
Lecture 94 Introduction to Pharma Marketing
Lecture 95Market Research in Pharma Business
Lecture 96 Consumer buying behavior
Lecture 97Product Life cycle - Basic Understanding
Lecture 98 STP - Strategic Positioning and Brand Differentiation
Lecture 99 Pricing Strategies
Lecture 100Distribution and Logistics
Lecture 101 Pharmaceutical Distribution
Lecture 102Promotion Management Process in a Pharmaceutical Company
Lecture 103 Setting and Quantifying Promotional Objectives
Lecture 104Promotional Budget Setting : Tools and Techniques
Lecture 105Basics of Advertising : Introduction
Lecture 106 Classifications of Advertising
Lecture 107 The Advertising agency
Lecture 108Classification of Doctors
Lecture 109 Moving Annual Total (MAT)
Lecture 110 CAGR
Lecture 111 Brand Potential
Section 5PHARMA BRAND STRATEGY MANAGEMENT
Lecture 112PRATICAL TRAINING SESSION : BRAND NAME, BRAND LOGO, TRADEMARKING
Lecture 113 Purpose of Pharma Brand Logo
Lecture 114Component of brand logo
Lecture 115Brand Name and TM Registration Process
Lecture 116How to design excellent brand logo?
Lecture 117Case study in brand name finalization
Lecture 118Brand Name Simulation
Lecture 119 Traditional Vs. Non-Traditional trademark
Lecture 120 Global Protection of the Pharma Brand
Lecture 121Rebranding in Pharmaceuticals
Lecture 122Brand Logo Development: Real Life Simulation
Lecture 123 Fundamental of Pharma Marketing Plan
Lecture 124Basic Know-How: Marketing Campaign Development
Lecture 125How to prepare a Pharma Brand Plan
Lecture 126 Decide about brand USP -What to promote
Lecture 127 How to prepare promotogram. Download sample Promotogram
Lecture 128Sample Allocation
Lecture 129 Importance of Visual Aid in Pharmaceutical Industry
Lecture 130BUYING SIGNAL
Lecture 131 Indications for Drugs: Approved vs. Non-approved
Lecture 132Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 133Step By Step Visual Aid Designing
Lecture 134 Guideline of Visual Aid Designin
Lecture 135Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 136 VISUAL AID PRINTING
Lecture 137 Detailing and e-detailing
Lecture 138 Marketing Plan followed by Visual Aid Development
Lecture 139Visual Aid, Literature reference Sample
Lecture 140 Creativity to develop brand essence
Lecture 141 Increase the brand reach with advance segmentation
Lecture 142 Concept of uniform branding for better brand acceptability
Lecture 143Concept of Brand Differentiation
Section 6BIOPHARMACEUTICALS AND BIOSIMILAR DEVELOPMENT PROCESS
Lecture 144Introduction : Biopharmaceuticals
Lecture 145 Classification of Biopharmaceutical
Lecture 146Introduction to Biosimilar
Lecture 147 Chemical Drugs Vs. Biologic Drugs
Lecture 148 Current Trends in Biopharmaceutical Market
Lecture 149Complexity of biopharma supply chain and operations
Lecture 150Biopharma - Market Segmentation
Lecture 151Blockbuster Biologic - Classifications, Indications, Global Sales
Lecture 152Recombinant protein
Lecture 153Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 154Monoclonal Antibodies
Lecture 155Synthetic Immunomodulators
Lecture 1561Production of Monoclonal Antibodies
Lecture 157Cytokines
Lecture 158Interferon
Lecture 159Erythropoiesis-stimulating agent
Lecture 160Biological Licensing Application (BLA)
Lecture 161Biosimilar Approval process
Lecture 162Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 163Pricing and cost effectiveness of biosimilars
Lecture 164Exclusivity Protections for Biopharmaceuticals
Lecture 165REMS Strategic Planning
Lecture 166Review : 351(a) vs. 351(k) pathway
Section 7STRATEGIC ORIENTATION IN PHARMA AND BIOPHARMA INDUSTRY
Lecture 167Licensing Vs. Outlicensing in Pharma / Biopharma Industry
Lecture 168Licensing - Advance Strategic Learning
Lecture 169Terms / Duration of License
Lecture 170Are improvements licensed
Lecture 171Financial of Licensing Deals
Lecture 172Milestone Payment
Lecture 173How are royalties structured in a licensing deal?
Lecture 174What accounts, inspection and audit provisions are in a license?
Lecture 175How is patenting dealt with in a license?
Lecture 176What warranties are in a license?
Lecture 177What competition law issues are there in licensing?
Lecture 178Co-development and co-marketing agreements in Pharmaceutical Strategic Management
Lecture 179Due Diligence Activities in Pharmaceutical Licensing
Lecture 180Detailed in-depth strategic understanding on Technology Transfer
Lecture 181Overview of contractual agreements in Technology Transfer
Lecture 182Confidentiality agreements
Lecture 183Material Transfer Agreements
Lecture 184Deeds of assignment or assignment deeds