Introduction
Who should attend
Features
Related Courses
Core Topics
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.
Pharma Market Access training is also available in 1 month advanced certification in Pharma Market Access and Pricing.
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.
Moreover, user can access the course at own pace. It allows the user to stop and start at their leisure.
Course snapshot:
- Course Code: RYD-099
- Title of the course: PG Certification in Pharma Market Access (PGPMA)
- Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
- Duration: 1 year from the date of initiation of the course.
- Eligibility: Graduation in any discipline.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
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
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:
- 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.
We also have 1 month certification course in pharmaceutical market access and pricing.
Related Courses
Some of the other related courses are mentioned below.
Followings are the few of the similar courses, you may be interested in
- Pharma Forecasting >> Click here
- Pharma Global Management >> Click here
- Biopharma Global Business Course >> Click here
- Drug Regulatory Affairs Course >> Click here
- Pharma Marketing >> Click here
- Online Training on CE certification >> Click here
- Medical devices regulatory affairs >> Click here
- Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
- USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> Click here
What are the topics or key areas which are covered in 1 year pharma market access course?
A comprehensive Market Access course for the pharmaceutical industry should cover a range of essential topics to provide a well-rounded understanding of the field. Here are the key topics that must be included:
Fundamentals of Market Access
- Definition and importance of market access in the pharmaceutical industry.
- Key stakeholders involved (patients, payers, providers, regulators).
- Market Access Strategic Planning.
- Value Dossier Preparation.
- Case Based Sessions.
Health Economics and Outcomes Research (HEOR)
- Basics of health economics.
- Cost-effectiveness analysis.
- Budget impact analysis.
- Quality of life measures (e.g., QALYs, DALYs).
- Erecting various HEOR models.
Pricing Strategies
- Methods for setting drug prices.
- International reference pricing.
- Value-based pricing.
- Differential pricing strategies.
- Reimbursement Strategies.
- Managing PBMs.
Reimbursement Processes
- Overview of reimbursement systems in key markets (US, EU, emerging markets).
- Payer perspectives and requirements.
- Negotiation strategies with payers.
Regulatory Environment
- Key regulatory bodies (FDA, EMA, etc.).
- Regulatory pathways for market approval.
- Post-market surveillance and pharmacovigilance.
Market Access Strategies
- Formulating and implementing market access strategies.
- Early access programs.
- Managed entry agreements.
Real-World Evidence (RWE)
- Importance and application of RWE in market access.
- Data sources and collection methods.
- Case studies demonstrating RWE in action.
Stakeholder Engagement
- Identifying and engaging with key stakeholders.
- Role of patient advocacy groups.
- Communication strategies for different stakeholders.
Health Technology Assessment (HTA)
- Purpose and process of HTA.
- Key HTA agencies and their methodologies.
- Impact of HTA on market access.
Global Market Access
- Differences in market access requirements across regions.
- Challenges in global market access.
- Strategies for successful global market entry.
Emerging Trends and Future Directions
- Impact of digital health and innovation on market access.
- Personalized medicine and its implications.
- Future trends in pricing, reimbursement, and market access.
Case Studies and Practical Applications
- Real-world case studies of successful market access strategies.
- Practical exercises and simulations.
- Group discussions and workshops to apply learned concepts.
Ethical and Legal Considerations
- Ethical issues in market access.
- Legal framework and compliance requirements.
- Addressing ethical dilemmas in market access decisions.
Section 1Market Access & Health Economics
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 4Introduction to Health Economics | Key terminologies related to health economics
Lecture 5HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 6Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 7Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 8Core 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 9QALY | How to calculate QALY | Importance and Significance
Lecture 10ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 11Pharmacoeconomic 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 12Pharmacoeconomic 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 13Pharmacoeconomic 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 14Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model
Lecture 15CER and PCOR
Section 2Discovery Development to Commercialization (Pharma / Biopharma R&D) - US Market
Lecture 16Pharma R&D Process & Introduction to drug discovery
Lecture 17Investigational New Drug Application (INDA)
Lecture 18New Drug Application (NDA)
Lecture 19Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 20Basic concept and understanding of the Generic Drug
Lecture 21Abbreviated New Drug Application (ANDA)
Lecture 22Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 23Handling of orange book
Lecture 24Purple Book: Significance | Searching | Assignments
Lecture 25Clinical Trials Terminologies
Lecture 26Patent & Exclusivity - Strategic Understanding
Section 3Regulatory Landscape - Europe
Lecture 27Introduction to EU Regulation
Lecture 28Orientation to European Countries and National Regulatory Bodies
Lecture 29EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 30Overview of EU Regulation
Lecture 31EMA and EMA Authorisation Process
Lecture 32EU MA Application Types and Strategic Planning
Lecture 33EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 34EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 35Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 36Accelerated assessment by EMEA
Lecture 37EU Adaptive Pathway
Section 4Market Access Strategic Planning
Lecture 38Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 39Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 40Indication Prioritization Case Study
Lecture 41Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 42AMCP Market Access Dossier Preparation
Lecture 43Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 44Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier
Lecture 45Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing
Lecture 46Budget Impact Analysis | Importance | Significance | Steps involved | Total Budget Impact Calculation | Simulation - BIA of novel molecule with real life example | Total Budget Impact Calculation for Novel Molecule
Lecture 47Markov Model | Significance | Importance | Time horizon - Significance | Real Life Development of Markov Model | Calculation
Lecture 48Pipeline in a molecule | Case Study
Section 5Pricing, Reimbursement and Formulary Placement
Lecture 49Drug Pricing Methodologies - I
Lecture 50Drug Pricing Methodologies II
Lecture 51Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 52Pharma Market Access Pricing Case Study
Lecture 53Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation
Lecture 54HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes
Lecture 55Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 56Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 57Sample Pricing Dossier : Case Analysis - How to make the price justification
Lecture 58Concept of Reference Pricing | IRP | ERP | Differences | Practical Examples
Section 6Forecasting and Market Size Analysis
Lecture 59Sales Forecasting in Lifesceience industry
Lecture 60New Product Forecast algorithms
Lecture 61Patient Based Forecasting Model | Applying more filters and variables
Lecture 62Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 63Prevalence Vs. Incidence Model
Lecture 64EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 65Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 66Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 67Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 68Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 69Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 70Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 71Bottom-up or Top-down forecasting : How and When | Practical cases
Lecture 72Simulation : Bottom-up forecasting
Lecture 73Assessment on Bottom-up forecasting
Lecture 74Oncology Brand Forecasting
Lecture 75Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 76Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 77QALY | How to calculate QALY | Importance and Significance
Lecture 78ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 79Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 80Compound Annual Growth Rate | CAGR Calculation
Lecture 81First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 82Forecasting Biosimilar | Key Factors to consider
Lecture 83Consensus Meeting
Lecture 84One Number Vs. Multi Number Forecasting
Lecture 85Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 86Treatment Algorithm and Forecasting : Case Study
Lecture 87Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 88Prescription Value Calculation
Lecture 89Commonly used Pharma Forecasting Tools | Understanding each types of tools | Time Series Analysis [ARIMA, Exponential Smoothing] | Regression Analysis | Machine Learning Models | Simulation Models | Delphi Method | Scenario Planning
Lecture 90Time Series Forecasting | Step by step time series forecasting | Characteristics of Time Series forecasting
Lecture 91ARIMA Model
Lecture 92ARIMA Model application on pharmaceutical industry | Application in different domains of pharma | Logical step by step Arima Model Development
Lecture 93Exponential Smoothing : in pharma forecasting | Smoothing Factor | Step by step working on Time Series Data by applying Exponential Smoothing
Section 7Real World Data and Real World Evidene
Lecture 94Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 95RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 96RWE in lifescycle management
Lecture 97RWD and RWE - Fit to use | Assessment
Lecture 98RWD data sources | Different types | Detailed understanding of each class
Lecture 99RWE - Study Design
Lecture 100RWE - Published Tool
Section 8Business Development, Licensing & Valuation Management
Lecture 101Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 102Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 103Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 104Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 105Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 106Numerical SWOT Practical training
Lecture 107Modelling 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 108Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 109Forecasting : Tools and Techniques
Lecture 110Market Sizing & Forecasting Case Study
Lecture 111Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 112Average Royalty Rate
Lecture 113Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 114Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 115Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 116Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 117SPECIAL PURPOSE VEHICLES (SPV)
Lecture 118Indication Splitting | Concept | Implementation feasibility analysis
Lecture 119Types of Deals from Discovery to Commercialization
Lecture 120Review: What are the fundamental areas of business development
Lecture 121Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 122Licensing Payment Schedule | Case Study
Lecture 123Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 124Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 125Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 126Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 127Step By Step Implementation of Licensing Deal by Business Development Team
Lecture 128Value Share Principle | Discounting of licensing deal | Discount Rate
Lecture 129DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 130Net Present Value (NPV) method : Calculation
Lecture 131Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium
Lecture 132Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 133Comparable Company Analysis method : Calculation
Lecture 134EBITDA Multiples | Importance in Pharma Biopharma BD&L | Calculation | Benchmarking EBITDA multiplies | Sourcing EBITDA multiples | Decoding EBITDA multiples value in different types of pharma and biopharma organizations
Lecture 135Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development
Lecture 136Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 137Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 138Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker
Lecture 139Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise
Lecture 140Due Diligence Activities in Pharmaceutical Licensing
Section 9Biologic and Biosimilar Market Access Strategic Planning
Lecture 141Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management
Lecture 142Biosimilar launch case study | Patent Dance Framework
Lecture 143Biosimilar Launch Framework
Lecture 144Biosimilar 180 Day Notice
Lecture 1453(A) List | Significance | Importance | How to interpret
Lecture 146Steps to win over innovator patents | Step wise planning
Lecture 147Biosimilar Launch Project Roadmap with defined stages of project
Lecture 148Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments
Lecture 149Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation
Lecture 150Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation
Lecture 151Biosimilar Launch Project With Milestones
Lecture 152Analysis of Biologic Patents | Work Assignments
Lecture 153Biologic Patent Insight Worksheet
Lecture 154Patent Thickets | Concept | Implication | Case Based Learning
Section 10Data Visualization in Market Access
Lecture 155Line Chart vs. Spline Chart
Lecture 156Basic Area Charts
Lecture 157Stacked Area Chart
Lecture 158Basic Bar Charts
Lecture 159Stacked Bar Charts
Lecture 160Basic Column Charts
Lecture 161Stacked Column Charts
Lecture 162Pie Chart
Lecture 163Donut Chart
Lecture 164What is a Scatter Plot?
Lecture 165Case Study: New Oncology Drug Launch Forecasting
Lecture 166Treemap Plot
Lecture 167Spiderweb chart
Lecture 168Polar Chart
Lecture 1693D Funnel Chart
Lecture 170Heatmap chart
Section 11Case Studies | Used Cases
Lecture 171Demand Forecasting for a Drug Targeting Duchenne Muscular Dystrophy (DMD) | Rare Disease Forecasting | Model Development | Assignment | Download Excel Work File
Lecture 172Case Study: Forecasting the Uptake of a New Cancer Drug After Launch in a Specific Region
Lecture 173Case Study: Forecasting Demand for a New Cancer Treatment Expected to Generate Billions in Sales Globally
Lecture 174Generic Drug Forecasting - Post Patent Expiry
Lecture 175Case Study: Estimating the Market Uptake of a Generic Version of a Popular Cholesterol-Lowering Drug
Lecture 176Data-Driven Forecasting Case Study: Market Share Forecast for a New Hypertension Drug
Lecture 177Forecasting During Early Stage of Development
Lecture 178Case Simulation : Demographic-Based Forecasting
Lecture 179Forecasting and Valuation for Weight Loss Drugs | Forecasting Model | Model Assumptions | Data Inputs | Projected Revenue Calculations
Lecture 180Forecasting Example for a Weight Loss Drug:
Section 12Handling and Managing Datasets
Lecture 181Introduction to Healthcare Datasets
Lecture 182Dataset 1: Claims Data (Insurance)
Lecture 183Dataset 2: Retail Pharmacy Prescription Data
Lecture 184Dataset 3: Longitudinal Patient Data
Lecture 185Characteristics of Different Set of Healthcare Data
Lecture 186Reimbursement and Pricing Datasets
Section 13Request for Course Certificate
