Introduction
Who should attend
Course Type
Duration
Eligibility
Certification
Course Deliverable
Features
Related Courses
This course will provide practical understanding about the pharma market access strategies, forecasting, pricing and reimbursement. This advanced online market access and pricing course covers pharmaceutical and biopharmaceutical market access strategic management and planning process. Hence, this course will demonstrate market access skills required for pharmaceutical and biopharmaceutical organization to success. The course provides real life case based simulations for better understanding the complex issues of market access, pricing, forecasting. As a result, it is easy for participants to understand the concepts. Moreover, cutting edge simulations help participants apply the knowledge in interactive real life simulation.
Above all, this market access training course focus on value pricing for market access which is important critical yet complex buzzword in biopharmaceutical industry. Also at the same time, course provides in-depth understanding on evidence-based pricing for pharmaceuticals.Â
In addition, this course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
The course can be completed at any place. So, it allows the user to stop and start at their leisure.Â
Moreover, user can access the course at own pace. It allows the user to stop and start at their leisure.Â
Course Code: RYD-089
Course Title: Advanced Certification in Pharma Market Access and Pricing (ADPM&A)
Who should attend?
- Pricing, Market Access Professionals who want to learn about regional markets.
- Regulatory professionals who want to learn about commercial issues.
- Strategic planners who want to know where they might go next
- Those who want insight into the way that markets influence each other
- Anyone who wants to understand global pricing issues
Online distance learning course. Course can be accessed online across anywhere 24×7.
1 month from the date of initiation of the course.
Graduation in any discipline.
Certificate will be provided at the end of the successful completion of the course
- Attend the course 24×7 by login to your dashboard. Therefore, one can attend lectures, simulation, self assessment tests and final certification examination online at own convenience.
- You will also be eligible to receive the course study modules, which you can download by login to your course page.
Course Features
This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of market access, pricing, forecasting and reimbursement. Moreover this market access training challenges participants to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Important Learning Features:Â
- Online 24×7 access from anywhere. Hence, one can learn at your convenience.
- The course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
- The course is build on interactive e-learning. Hence, it helps user to understand of the concepts effectively.
- Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.
Course Coverage Area
- The course provided comprehensive advanced understanding on global and national pricing, market access, pricing, forecasting.
- Advance practical training in health economics and evidence based pricing concepts.
- Advance training on market assessment to determine pricing models.
- Detailed training on forecasting models and techniques with practical case studies.
- Training on value dossier preparation.
Related Courses
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- Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
- USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> Click here
Section 1Market Access, Pharamcoeconomics, Pricing and Reimbursement - Fundamental Understanding
Lecture 1Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 2Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 3Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 4Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 5Indication Prioritization Case Study
Lecture 6Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 7AMCP Market Access Dossier PreparationÂ
Lecture 8Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 9First-in-class | Best-in-class | Market Access Strategic Decision MakingÂ
Lecture 10Pharma Market Access Pricing Case Study : Interchangeable PricingÂ
Lecture 11Introduction to Health Economics | Key terminologies related to health economics
Lecture 12HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 13Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysisÂ
Lecture 14Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | UncertaintyÂ
Lecture 15Core 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 16Pharmacoeconomic 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 17Pharmacoeconomic 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 18Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATPÂ
Lecture 19Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov modelÂ
Lecture 20CER and PCOR
Lecture 21QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 22ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Lecture 23Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?Â
Lecture 24RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 25RWD and RWE in Product Lifecycle Management
Lecture 26RWD and RWE - Fit to use | Assessment
Lecture 27RWD data sources | Different types | Detailed understanding of each classÂ
Lecture 28Drug Pricing Methodologies I
Lecture 29Drug Pricing Methodologies II
Lecture 30Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 31Pharma Market Access Pricing Case Study : Interchangeable PricingÂ
Section 2Market Access Regulatory Landscape - United Sales
Lecture 32Pharma R&D Process & Introduction to drug discovery
Lecture 33Investigational New Drug Application (INDA)
Lecture 34New Drug Application (NDA)Â
Lecture 35Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 36Basic concept and understanding of the Generic Drug
Lecture 37Abbreviated New Drug Application (ANDA)Â
Lecture 38Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 39Handling of orange book
Lecture 40Purple Book: Significance | Searching | Assignments
Lecture 41Clinical Trials Terminologies
Lecture 42Patent & Exclusivity - Strategic Understanding
Section 3Market Access Regulatory Landscape - Europe
Lecture 43Introduction to EU RegulationÂ
Lecture 44Orientation to European Countries and National Regulatory Bodies
Lecture 45EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 46Overview of EU RegulationÂ
Lecture 47EMA and EMA Authorisation Process
Lecture 48EU MA Application Types and Strategic Planning
Lecture 49EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 50EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 51Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 52Accelerated assessment by EMEA
Lecture 53EU Adaptive Pathway
Section 4Forecasting and Market Size Analysis
Lecture 54Sales Forecasting in Lifesceience industry
Lecture 55New Product Forecast algorithms
Lecture 56Patient Based Forecasting Model | Applying more filters and variables
Lecture 57Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 58Prevalence Vs. Incidence Model
Lecture 59EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 60Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 61Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 62Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 63Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 64Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 65Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 66Bottom-up or Top-down forecasting : How and When | Practical cases
Lecture 67Simulation : Bottom-up forecasting
Lecture 68Assessment on Bottom-up forecasting
Lecture 69Oncology Brand Forecasting
Lecture 70Revenue Forecasting Case Study - Novel AntihypertensiveÂ
Lecture 71Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Lecture 72First-in-class | Best-in-class | Market Access Strategic Decision MakingÂ
Lecture 73Forecasting Biosimilar | Key Factors to consider
Lecture 74Consensus MeetingÂ
Lecture 75One Number Vs. Multi Number Forecasting
Lecture 76Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Section 5Market Access - Commercialization
Lecture 77Market Access Strategic Planning Process | Knowledge Area of Market Access Business Development Professionals | Lead targeting | Licensing term sheets
Lecture 78Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 79Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 80Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 81Numerical SWOT Practical training
Lecture 82Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 83Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 84Forecasting : Tools and Techniques
Lecture 85Market Sizing & Forecasting Case Study
Lecture 86Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 87Average Royalty Rate
Lecture 88Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 89Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 90Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 91Types of deal from discovery to commercialization
Lecture 92Licensing Payment Scheduling: Different Types | Case Study
Lecture 93Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 94Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 95Due Diligence Activities in Pharmaceutical Licensing
Section 6Financials - Valuation Management
Lecture 96Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 97Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 98Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 99Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 100Value Share Principle | Discounting of licensing deal | Discount RateÂ
Section 7Reference | Add on learning
Lecture 101Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 102Compound Annual Growth Rate | CAGR Calculation
Section 8Request for Course Certificate
