InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 / 19800 INR.
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Pharma Market Access and Pricing


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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 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

  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. The course challenges students 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.

Related Courses

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  • Medical devices regulatory affairs >> Click here
  • Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
  • USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> Click here
Section 1Market Access, 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 9Drug Payment Methodologies
Lecture 10Pricing in Pharmaceuticals
Lecture 11Pricing Market Access Strategies Case Studies
Section 2Market Access Regulatory Landscape - United Sales
Lecture 12Pharma R&D Process & Introduction to drug discovery
Lecture 13Investigational New Drug Application (INDA)
Lecture 14New Drug Application (NDA) 
Lecture 15Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 16Basic concept and understanding of the Generic Drug
Lecture 17Abbreviated New Drug Application (ANDA) 
Lecture 18Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 19Handling of orange book
Lecture 20Purple Book: Significance | Searching | Assignments
Lecture 21Clinical Trials Terminologies
Lecture 22Patent & Exclusivity - Strategic Understanding
Section 3Market Access Regulatory Landscape - Europe
Lecture 23Introduction to EU Regulation 
Lecture 24Orientation to European Countries and National Regulatory Bodies
Lecture 25EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 26Overview of EU Regulation 
Lecture 27EMA and EMA Authorisation Process
Lecture 28EU MA Application Types and Strategic Planning
Lecture 29EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 30EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 31Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 32Accelerated assessment by EMEA
Lecture 33EU Adaptive Pathway
Section 4Market Access - Forecasting - Models, Techniques
Lecture 34Sales Forecasting in Lifesceience industry
Lecture 35New Product Forecast algorithms
Lecture 36Patient Vs. Prescription Model
Lecture 37Prescription Based Forecasting Model
Lecture 38Prevalence Vs. Incidence Model
Lecture 39EPI based model
Lecture 40Patient Based Sales Forecasting
Lecture 41Market Sizing Assignment 1 - Hands on Training
Lecture 42Market Sizing Assignment 2 - Hands on Training
Lecture 43Degerming the value of a prescription
Lecture 44Rebate
Lecture 45Formulary Placement of the brand
Lecture 46Concomitancy and polypharmacy
Lecture 47Forecasting Techniques in Pharma Industry
Lecture 48Bottom-up or Top-down forecasting : How and When | Practical cases
Section 5Market Access - Commercialization
Lecture 49Market Access Strategic Planning Process | Knowledge Area of Market Access Business Development Professionals | Lead targeting | Licensing term sheets
Lecture 50Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 51Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 52Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 53Numerical SWOT Practical training
Lecture 54Modelling 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 55Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 56Forecasting : Tools and Techniques
Lecture 57Market Sizing & Forecasting Case Study
Lecture 58Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 59Average Royalty Rate
Lecture 60Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 61Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 62Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 63Types of deal from discovery to commercialization
Lecture 64Licensing Payment Scheduling: Different Types
Lecture 65Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 66Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 67Due Diligence Activities in Pharmaceutical Licensing
Section 6Financials - Valuation Management
Lecture 68Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 69Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 70Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 71Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model