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.Â
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
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.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-099
Course Title: PG Certification in Pharma Market Access (PGPMA)
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 year 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.
We also have 1 month certification course in pharmaceutical market access and pricing.
Some of the other related courses are mentioned below.
Related Courses
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
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 6Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 7Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | UncertaintyÂ
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 SignificanceÂ
Lecture 10ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
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 & ATPÂ
Lecture 14Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov modelÂ
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)Â
Lecture 19Biological Licensing Application (BLA)Â | 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)Â
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 RegulationÂ
Lecture 28Orientation to European Countries and National Regulatory Bodies
Lecture 29EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 30Overview of EU RegulationÂ
Lecture 31EMA and EMA Authorisation Process
Lecture 32EU MA Application Types and Strategic Planning
Lecture 33EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
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 PreparationÂ
Lecture 43Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 5Pricing, Reimbursement and Formulary Placement
Lecture 44Drug Pricing Methodologies - I
Lecture 45Drug Pricing Methodologies II
Lecture 46Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 47Pharma Market Access Pricing Case Study
Section 6Forecasting and Market Size Analysis
Lecture 48Sales Forecasting in Lifesceience industry
Lecture 49New Product Forecast algorithms
Lecture 50Patient Based Forecasting Model | Applying more filters and variables
Lecture 51Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 52Prevalence Vs. Incidence Model
Lecture 53EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 54Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 55Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 56Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 57Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 58Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 59Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 60Bottom-up or Top-down forecasting : How and When | Practical cases
Lecture 61Simulation : Bottom-up forecasting
Lecture 62Assessment on Bottom-up forecasting
Lecture 63Oncology Brand Forecasting
Lecture 64Revenue Forecasting Case Study - Novel AntihypertensiveÂ
Lecture 65Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Lecture 66QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 67ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Lecture 68Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 69Compound Annual Growth Rate | CAGR Calculation
Lecture 70First-in-class | Best-in-class | Market Access Strategic Decision MakingÂ
Lecture 71Forecasting Biosimilar | Key Factors to consider
Lecture 72Consensus MeetingÂ
Lecture 73One Number Vs. Multi Number Forecasting
Lecture 74Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Section 7Real World Data and Real World Evidene
Lecture 75Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?Â
Lecture 76RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 77RWE in lifescycle management
Lecture 78RWD and RWE - Fit to use | AssessmentÂ
Lecture 79RWD data sources | Different types | Detailed understanding of each classÂ
Lecture 80RWE - Study Design
Lecture 81RWE - Published Tool
Section 8Business Development, Licensing & Valuation Management
Lecture 82Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 83Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 84Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 85Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 86Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 87Numerical SWOT Practical training
Lecture 88Modelling 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 89Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 90Forecasting : Tools and Techniques
Lecture 91Market Sizing & Forecasting Case Study
Lecture 92Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 93Average Royalty Rate
Lecture 94Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 95Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 96Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 97Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 98SPECIAL PURPOSE VEHICLES (SPV)
Lecture 99Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 100Types of Deals from Discovery to Commercialization
Lecture 101Review: What are the fundamental areas of business development
Lecture 102Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 103Licensing Payment Schedule | Case StudyÂ
Lecture 104Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 105Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 106Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 107Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 108Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 109Value Share Principle | Discounting of licensing deal | Discount RateÂ
Section 9Case Study
Lecture 110Case Study - 1
Lecture 111Case study 2
Lecture 112Case study 3
Lecture 113Case study 4
Lecture 114Case study 5
Lecture 115Case study 6
Lecture 116Case study 7
Lecture 117Case study 8
Lecture 118Case study 9
Lecture 119Case study 10
Section 10Request for Course Certificate
