InstructorRoyed Training
TypeOnline Course
Student Enrolled3
Price$490 USD / 27500 INR.
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pharmaceutical project management course

Introduction

Feature

Who should attend

Key learning area

Related Courses

Pharmaceutical Project Maangement Course by Royed Training

In the dynamic landscape of the pharmaceutical industry, effective project management is paramount for success. Royed Training’s Advanced Certification in Pharmaceutical Project Management offers a comprehensive and advanced curriculum designed to equip professionals with the specialized skills and knowledge. In fact this course is ideal for those who want to excel in managing complex projects within the pharmaceutical sector. This intensive program dives deep into the intricacies of pharmaceutical project management, covering key concepts, methodologies, and best practices essential for navigating the unique challenges of this rapidly evolving industry.

This course provides training on the pharma and biopharma R&D discovery, development and commercialization pipeline, project and portfolio management.

This online Pharmaceutical and Biopharmaceutical Project Management training course utilizes interactive learning tools to guide each participant through the steps of the project management process which takes place in the pharmaceutical, biotech keeping in view both in innovative and generic industry.

The course is designed to challenge 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. The course can be completed at any pace, allowing the user to stop and start at their leisure.

  • Course Title: Advance Certification in Pharmaceutical Project Management
  • Course Code: RYD-047
  • Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
  • Duration of the course: 1 Month
  • Eligibility: Graduation in any discipline.
  • Course Certificates: Certificate will be provided at the end of the successful completion of the course.
  • Deliverables: Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination. You will also eligible to receive the course study modules, which you can download by login to your course page.

Features of Pharma Project Management Course

  • This pharma project management covers all aspects of the project and portfolio management from drug discovery development, regulatory, commercialization of the innovator drugs, innovator biologics, generics and biosimilars.
  • The course provides orientation to job related practical aspects of the pharmaceutical project managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Project Management Professionals works in pharmaceutical and biopharmaceutical company..
  • One of the important feature of the course is real life simulation on project related critical decision making process. Hence, these simulations help to enhance the decision making skills which is the core aspects of the pharmaceutical project manager’s working.

Who should attend this course?

  • Professionals already working in pharmaceutical and biopharmaceutical company.
  • Project managers seeking to specialize in pharmaceutical projects.
  • Those who moving into pharmaceutical project management from different functional areas.
  • Pharmaceutical R&D scientist, Regulatory Affairs Professionals, market access and strategic management professionals.

Key Area I

  • Drug Development to Commercialization – R&D management and related strategic planning. 
  • Basics of Biopharmaceutical – Development to commercialization
  • Advanced training on various classes of biopharmaceuticals. 
  • Understanding on the biopharmaceutical regulatory affairs, registration requirements. 
  • Biopharma strategic management training
  • Biopharma market access | Market sizing | Forecasting | Valuation | Pricing | Reimbursement
  • Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
  • Objective – Strategy – Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques – Web Search | Conference | Confidentiality – CDA | MTA
  • Life cycle extension / Loss of Exclusivity – LOE strategies.
  • Pharma Marketing and branding Strategic Planning
  • Generic Drug Strategic Planning
  • Strategic Pathways for marketing authorization of the pharmaceutical and – biopharmaceutical products
  • Exclusive training on Biopharmaceutical and biosimilar management.
  • In depth training on Licensing in the pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion

Key Area II

  • Financial Planning and Management for pharma strategic management professionals
  • Modelling and Deal Valuation – Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
  • Royalty Management – Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking – Concept and Calculation | Minimum Annual Royalties | Reach through royalties
  • Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
  • Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
  • Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales – Max-Min Approach.
  • EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation | EBITDA Multiples 
  • Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary – Secondary – Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
  • Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Section 1Fundamental Understanding of Project Management
Lecture 1Introduction and definition
Lecture 2Difference between Project and Program
Lecture 3Phasing of Projects for better effectiveness / outcome of the Project 
Lecture 4Project Management Constraint
Lecture 5Review Test
Lecture 6Introduction to Pharma Project Management  - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 7Pharma Project Management Terminologies
Lecture 8Project Tracking 
Lecture 9Asset Tracking 
Section 2Pharma and Biopharma R&D Project and Portfolio Management
Lecture 10Fundamental of Pharma R&D - Discovery to Commercialization Process
Lecture 11Investigational New Drug Application (INDA)
Lecture 12New Drug Application (NDA) 
Lecture 13Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 14Basic concept and understanding of the Generic Drug
Lecture 15Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 16Handling of orange book
Lecture 17Purple Book: Significance | Searching | Assignments
Lecture 18USFDA expedited programs
Lecture 19505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 20Advance Learning on 505B2 Pathway
Lecture 21Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 22Project Terminations
Lecture 23Market Access - Understanding key terminologies and various key steps in market access
Lecture 24Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 25Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 26Indication Prioritization Case Study
Lecture 27Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 28Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 29Cycle Times (Stage or phase lengths)
Lecture 30Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 31Milestone chart
Lecture 32Levels of Project and Portfolio Management
Lecture 33Types of deal from discovery to commercialization
Lecture 34First-in-class | Best-in-class | Market Access Strategic Decision Making 
Lecture 35Introduction to Health Economics | Key terminologies related to health economics
Lecture 36HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 37Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis 
Lecture 38Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty 
Lecture 39Core 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 40Pharmacoeconomic 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 41Pharmacoeconomic 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 42Pharmacoeconomic 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 43Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model 
Lecture 44CER and PCOR
Lecture 45QALY | How to calculate QALY | Importance and Significance 
Lecture 46ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Section 3Concepts related Portfolio Management
Lecture 47Strategic Planning During Clinical Trials
Lecture 48LOE Strategies for Innovator Brands with case study
Lecture 49Evergreening - Patent Life Extension Strategies
Lecture 50Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology
Lecture 51In-Licensing Vs. Outlicensing
Lecture 52Licensing - Advance Learning 
Lecture 53Drug Repurposing
Lecture 54Advance study on Para IV Filing
Lecture 55Para IV Notices
Lecture 56Pay For Delay Strategy
Lecture 57REMS Strategic Planning 
Lecture 58Compulsory Licensing
Lecture 59Licensing & Technology Transfer
Lecture 60Pipeline in a Molecule
Lecture 61Patent Cliff
Lecture 62Due Diligence Activities in Pharmaceutical Licensing
Lecture 63Paediatric Exclusivity and Paediatric Study Plan Development
Section 4Strategic Project Planning and Portfolio Management
Lecture 64Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 65Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 66Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 67Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 68Numerical SWOT Practical training
Lecture 69Modelling and Deal Valuation - Top Down Modeal | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 70Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 71Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 72Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 73Negotiation Skill Training for Project Management Professionals
Lecture 74Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 75Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 76Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms 
Section 5Forecasting, Market Sizing, Market Potential Analysis
Lecture 77Sales Forecasting in Life Science Industry
Lecture 78New Product Forecast Algorithm
Lecture 79Patient Based Forecasting Model | Applying more filters and variables
Lecture 80Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 81Prevalence Vs. Incidence Model
Lecture 82EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 83Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 84Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 85Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 86Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 87Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 88Market Sizing & Forecasting Case Study
Lecture 89Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 90Forecasting : Tools and Techniques
Section 6Royalty Management
Lecture 91Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 92Average Royalty Rates
Lecture 93Factors affecting Royalty Rates
Section 7Finance and Valuation Management
Lecture 94Training on Basic Finance  |  Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 95Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 96Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 97Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 98Licensing Payment Schedule | Case Study
Lecture 99Licensing Term Sheet | Importance | Significance | Content of the Term Sheet | Sample Predesigned Term Sheet of Pharma  Licensing Deal 
Lecture 100Value Share Principle | Discounting of licensing deal | Discount Rate 
Lecture 101DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 102Net Present Value (NPV) method : Calculation
Lecture 103Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium 
Lecture 104Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 105Comparable Company Analysis method : Calculation
Section 8Evidence based decision making | Real World Data (RWD) | Real World Evidence (RWE)
Lecture 106Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 107RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 108RWD and RWE in Product Lifecycle Management
Lecture 109RWD and RWE - Fit to use | Assessment 
Lecture 110RWD data sources | Different types | Detailed understanding of each class 
Section 9Portfolio Benchmarking
Lecture 111Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 112Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development 
Lecture 113Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 114Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 115Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker