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-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 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
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 PreparationÂ
Lecture 8Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 9Pricing in Pharmaceuticals
Lecture 10Pricing Market Access Strategies Case Studies
Lecture 11Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 12Pharma Market Access Pricing Case Study : Interchangeable PricingÂ
Lecture 13Why Is Market Research Important in Pharmaceutical Business?
Lecture 14Market Research - Customer Engagement through feedback mechanismÂ
Lecture 15Product Life cycleÂ
Lecture 16Advance - Strategic Planning in Product Life cycle Management
Lecture 17Segmentation, Targeting and Positioning
Lecture 18Distribution Channel in Pharmaceutical IndustryÂ
Section 2Market Access Regulatory Landscape - United Sales
Lecture 19Pharma R&D Process & Introduction to drug discovery
Lecture 20Investigational New Drug Application (INDA)
Lecture 21New Drug Application (NDA)Â
Lecture 22Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 23Basic concept and understanding of the Generic Drug
Lecture 24Abbreviated New Drug Application (ANDA)Â
Lecture 25Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 26Handling of orange book
Lecture 27Purple Book: Significance | Searching | Assignments
Lecture 28Clinical Trials Terminologies
Lecture 29Patent & Exclusivity - Strategic Understanding
Section 3Market Access Regulatory Landscape - Europe
Lecture 30Introduction to EU RegulationÂ
Lecture 31Orientation to European Countries and National Regulatory Bodies
Lecture 32EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 33Overview of EU RegulationÂ
Lecture 34EMA and EMA Authorisation Process
Lecture 35EU MA Application Types and Strategic Planning
Lecture 36EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 37EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 38Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 39Accelerated assessment by EMEA
Lecture 40EU Adaptive Pathway
Section 4Forecasting and Market Size Analysis
Lecture 41Sales Forecasting in Lifesceience industry
Lecture 42New Product Forecast algorithms
Lecture 43Patient Based Forecasting Model | Applying more filters and variables
Lecture 44Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 45Prevalence Vs. Incidence Model
Lecture 46EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 47Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 48Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 49Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 50Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 51Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 52Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 53Bottom-up or Top-down forecasting : How and When | Practical cases
Lecture 54Simulation : Bottom-up forecasting
Lecture 55Assessment on Bottom-up forecasting
Lecture 56Oncology Brand Forecasting
Lecture 57Revenue Forecasting Case Study - Novel AntihypertensiveÂ
Lecture 58Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Lecture 59QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 60ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Section 5Market Access - Commercialization
Lecture 61Market Access Strategic Planning Process | Knowledge Area of Market Access Business Development Professionals | Lead targeting | Licensing term sheets
Lecture 62Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 63Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 64Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 65Numerical SWOT Practical training
Lecture 66Modelling 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 67Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 68Forecasting : Tools and Techniques
Lecture 69Market Sizing & Forecasting Case Study
Lecture 70Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 71Average Royalty Rate
Lecture 72Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 73Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 74Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 75Types of deal from discovery to commercialization
Lecture 76Licensing Payment Scheduling: Different Types | Case Study
Lecture 77Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 78Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 79Due Diligence Activities in Pharmaceutical Licensing
Lecture 80
Section 6Financials - Valuation Management
Lecture 81Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 82Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 83Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 84Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 85Value Share Principle | Discounting of licensing deal | Discount RateÂ
Section 7Reference | Add on learning
Lecture 86Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 87Compound Annual Growth Rate | CAGR Calculation
