InstructorRoyed Training
TypeOnline Course
Student Enrolled16
Price$490 / 27500 INR.
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pharma market access and pricing training

Introduction

Who should attend

Eligibility

Course Deliverable

Features

Related Courses

About PMA

market access pricing

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. 

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-089
  • Title of the Course: Advanced Certification in Pharma Market Access and Pricing (ADPM&A)
  • Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
  • Duration: 1 Month.
  • 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

Graduation in any discipline.

  1. 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.
  2. 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: 

  • 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.
  • Health Economics.
  • Health Technology Assessments.
  • Patient Advocacy.

Related Courses

At Royed Training, we have 1 year PG Cortication in Pharma Market Access.

Followings are the few of the similar courses, you may be interested in

  • Pharma Global Management >> Click here
  • Biopharma Global Business Course >> Click here
  • Drug Regulatory Affairs Course >> 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 is Market Access?

Pharmaceutical market access refers to the process by which pharmaceutical companies gain approval, reimbursement, and availability for their products in healthcare systems. Hence it allows the patients to access and benefit from those medications. Above all, pharma market access training involves a combination of regulatory, economic, and clinical considerations to ensure that pharmaceutical products are accessible to patients who need them.

Focus Area for Market Access Professionals

Here are the focus area where market access professionals focuses on day to day basis.

Regulatory Approval

Before a pharmaceutical product can be marketed, it must undergo a rigorous approval process by regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. These agencies evaluate the safety, efficacy, and quality of the product based on preclinical and clinical trial data provided by the manufacturer. That is the reason, Royed Market Access training provides hands-on knowledge on regulatory approval process in EU and US market.

Reimbursement and Pricing

Once a product receives regulatory approval, the next step is to secure reimbursement from public and private payers, such as government healthcare programs, insurance companies, or health maintenance organizations. Hence, this involves demonstrating the clinical and economic value of the medication compared to existing treatments. Therefore, pharmaceutical companies often engage in price negotiations with payers to determine an appropriate price that balances affordability and profitability. In fact our course provides key insight on pricing and reimbursement with case studies.

Health Economics (HE) and Health Technology Assessment (HTA)

HE and HTA agencies evaluate the clinical effectiveness, cost-effectiveness, and budget impact of pharmaceutical products. These assessments help inform reimbursement decisions by payers, as they consider factors such as clinical outcomes, patient population, cost-effectiveness, and budget impact on the healthcare system. At Royed Pharma Market Access course, advanced training on health economics and health Technology Assessment process. Hence, one can easily plan, evaluate and pick best possible therapeutic alternatives which provides best value.

Market Access Strategy

This is the core focus area for the market professionals. Pharmaceutical companies develop market access strategies to navigate the complex landscape of regulations, payer requirements, and pricing negotiations. Therefore it involves identifying target markets, understanding the local healthcare systems, building relationships with key stakeholders, and tailoring evidence and value messages to demonstrate the benefits of their products. Royed Pharma Market Access course provides all possible insight on market access strategic planning process.

Real-World Evidence

Real World Evidence is the buzz-word today in Pharmaceutical Industry. Increasingly, payers and regulatory authorities are placing importance on real-world evidence (RWE) to support market access decisions. RWE refers to data collected from real-world settings, such as observational studies and patient registries, to assess the long-term safety, effectiveness, and value of pharmaceutical products beyond clinical trials. In 2023, Royed Market Access course is now updated with real world data, real world evidence.

Patient Access Programs

Pharmaceutical companies may develop patient access programs to help eligible patients gain access to their medications. These programs may offer financial assistance, patient support services, or other initiatives to help overcome barriers to access, particularly for patients facing financial hardship or with limited insurance coverage. Hence, Patient Access Program is the key learning area for the Market Access Professionals.

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 Preparation 
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 Making 
Lecture 10Introduction to Health Economics | Key terminologies related to health economics
Lecture 11HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 12Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis 
Lecture 13Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty 
Lecture 14Core 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 15Pharmacoeconomic 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 16Pharmacoeconomic 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 17Pharmacoeconomic 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 18Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model 
Lecture 19CER and PCOR
Lecture 20QALY | How to calculate QALY | Importance and Significance 
Lecture 21ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Lecture 22Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 23RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 24RWD and RWE in Product Lifecycle Management
Lecture 25RWD and RWE - Fit to use | Assessment
Lecture 26RWD data sources | Different types | Detailed understanding of each class 
Lecture 27Drug Pricing Methodologies I
Lecture 28Drug Pricing Methodologies II
Lecture 29Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 30Pharma Market Access Pricing Case Study : Interchangeable Pricing 
Lecture 31Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 32Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 33Pharma Market Access Pricing Case Study : Interchangeable Pricing 
Lecture 34Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation 
Lecture 35HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes 
Section 2Market Access Regulatory Landscape - United Sales
Lecture 36Pharma R&D Process & Introduction to drug discovery
Lecture 37Investigational New Drug Application (INDA)
Lecture 38New Drug Application (NDA) 
Lecture 39Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 40Basic concept and understanding of the Generic Drug
Lecture 41Abbreviated New Drug Application (ANDA) 
Lecture 42Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 43Handling of orange book
Lecture 44Purple Book: Significance | Searching | Assignments
Lecture 45Clinical Trials Terminologies
Lecture 46Patent & Exclusivity - Strategic Understanding
Section 3Market Access Regulatory Landscape - Europe
Lecture 47Introduction to EU Regulation 
Lecture 48Orientation to European Countries and National Regulatory Bodies
Lecture 49EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 50Overview of EU Regulation 
Lecture 51EMA and EMA Authorisation Process
Lecture 52EU MA Application Types and Strategic Planning
Lecture 53EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 54EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 55Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 56Accelerated assessment by EMEA
Lecture 57EU Adaptive Pathway
Section 4Forecasting and Market Size Analysis
Lecture 58Sales Forecasting in Lifesceience industry
Lecture 59New Product Forecast algorithms
Lecture 60Patient Based Forecasting Model | Applying more filters and variables
Lecture 61Rx Based Forecasting Model | Differences between Patient Based and Rx Based Forecasting Model | Which model to use and when?
Lecture 62Prevalence Vs. Incidence Model
Lecture 63EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 64Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 65Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 66Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 67Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 68Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 69Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 70Bottom-up or Top-down forecasting : How and When | Practical cases
Lecture 71Simulation : Bottom-up forecasting
Lecture 72Assessment on Bottom-up forecasting
Lecture 73Oncology Brand Forecasting
Lecture 74Revenue Forecasting Case Study - Novel Antihypertensive 
Lecture 75Portfolio Based Forecasting | Forecasting Model Development in Excel 
Lecture 76First-in-class | Best-in-class | Market Access Strategic Decision Making 
Lecture 77Forecasting Biosimilar | Key Factors to consider
Lecture 78Consensus Meeting 
Lecture 79One Number Vs. Multi Number Forecasting
Lecture 80Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 81Treatment Algorithm and Forecasting 
Lecture 82Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 83Prescription Value Calculation 
Section 5Market Access - Commercialization
Lecture 84Market Access Strategic Planning Process | Knowledge Area of Market Access Business Development Professionals | Lead targeting | Licensing term sheets
Lecture 85Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 86Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 87Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 88Numerical SWOT Practical training
Lecture 89Modelling 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 90Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 91Forecasting : Tools and Techniques
Lecture 92Market Sizing & Forecasting Case Study
Lecture 93Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 94Average Royalty Rate
Lecture 95Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 96Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 97Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 98Types of deal from discovery to commercialization
Lecture 99Licensing Payment Scheduling: Different Types | Case Study
Lecture 100Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 101Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 102Due Diligence Activities in Pharmaceutical Licensing
Lecture 103Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier
Lecture 104Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing
Lecture 105Budget 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 106Markov Model | Significance | Importance | Time horizon - Significance | Real Life Development of Markov Model | Calculation
Section 6Financials - Valuation Management
Lecture 107Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 108Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 109Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 110Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 111Value Share Principle | Discounting of licensing deal | Discount Rate 
Section 7Reference | Add on learning
Lecture 112Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 113Compound Annual Growth Rate | CAGR Calculation
Section 8Request for Course Certificate