Introduction
Course Type
Course Duration
Feature
Eligibility
Who should attend
Certification
Course Deliverable
Key learning area
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
Online distance learning course. Course can be accessed online across anywhere 24×7.
1 Month
- 24×7 Online Access – Access anytime from anywhere across globe.
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.Â
- Flexible online final examination (Computer Based Test by secure mode)
- Real life Case Study module will be provided along with the course, material.Â
Graduation in any discipline.
- Pharmaceutical & Bio-Pharmaceutical professionals seeking to enhance / update knowledge about pharmaceutical project management
- Those moving into pharmaceutical project managementÂ
- Pharmaceutical R&D scientist and Regulatory Affairs ProfessionalsÂ
- Anyone who will be working at portfolio management projects of pharmaceutical companies
 Certificate will be provided at the end of the successful completion of the course
- 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.
Key Areas of Learning:
- Detailed understanding in drug discovery – development to commercialization process.
- Strategic look into R&D project management in pharmaceutical and biopharmaceutical industry.
- Turns to the key links of pharma projects with pharma business strategy and portfolio management.
- Pharmaceutical Project Manager’s Skill training – Introduction to Project Management, Beginning a Project, Project Planning, Project Budgeting, Project Scheduling, Project Execution, Monitoring and Controlling the Project, Summary of Project Management Knowledge, Tools To Help Make a Project Manager Succeed.
- Drug Discovery Development project management – timeline creation with business outcome.
- Project Evaluation process.
- Financial knowledge for pharmaceutical industry.
- Project Execution.
- Customized formats, charts, logs for detailed project management systems and controls. Practical Training on documentation.
- Handling of IT system and Project software.
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 ProjectÂ
Lecture 4Project Management Constraint
Lecture 5Qualities of a Good Project Leader
Lecture 6Review Test
Lecture 7Introduction to Pharma Project Management - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 8Pharma Project Management Terminologies
Lecture 9Project TrackingÂ
Lecture 10Asset TrackingÂ
Section 2Pharma and Biopharma R&D Project and Portfolio Management
Lecture 11Fundamental of Pharma R&D - Discovery to Commercialization Process
Lecture 12Investigational New Drug Application (INDA)
Lecture 13New Drug Application (NDA)Â
Lecture 14Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 15Basic concept and understanding of the Generic Drug
Lecture 16Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 17Handling of orange book
Lecture 18Purple Book: Significance | Searching | Assignments
Lecture 19USFDAÂ expedited programs
Lecture 20505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 21Advance Learning on 505B2 Pathway
Lecture 22Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 23Project Terminations
Lecture 24Market Access - Understanding key terminologies and various key steps in market access
Lecture 25Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 26Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 27Indication Prioritization Case Study
Lecture 28Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 29Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 30Cycle Times (Stage or phase lengths)
Lecture 31Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 32Milestone chart
Lecture 33Levels of Project and Portfolio Management
Lecture 34Types of deal from discovery to commercialization
Section 3Concepts related Portfolio Management
Lecture 35Strategic Planning During Clinical Trials
Lecture 36LOE Strategies for Innovator Brands with case study
Lecture 37Evergreening - Patent Life Extension Strategies
Lecture 38Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology
Lecture 39In-Licensing Vs. Outlicensing
Lecture 40Licensing - Advance LearningÂ
Lecture 41Drug Repurposing
Lecture 42Advance study on Para IV Filing
Lecture 43Para IV Notices
Lecture 44Pay For Delay Strategy
Lecture 45REMS Strategic PlanningÂ
Lecture 46Compulsory Licensing
Lecture 47Licensing & Technology Transfer
Lecture 48Pipeline in a Molecule
Lecture 49Patent Cliff
Lecture 50Due Diligence Activities in Pharmaceutical Licensing
Lecture 51Paediatric Exclusivity and Paediatric Study Plan Development
Section 4Strategic Project Planning and Portfolio Management
Lecture 52Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheetsÂ
Lecture 53Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 54Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 55Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 56Numerical SWOT Practical training
Lecture 57Modelling 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 58Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 59Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 60Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 61Negotiation Skill Training for Project Management Professionals
Lecture 62Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 63Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Section 5Forecasting, Market Sizing, Market Potential Analysis
Lecture 64Sales Forecasting in Life Science Industry
Lecture 65New Product Forecast Algorithm
Lecture 66Patient Based Forecasting Model | Applying more filters and variables
Lecture 67Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 68Prevalence Vs. Incidence Model
Lecture 69EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 70Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 71Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 72Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 73Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 74Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 75Market Sizing & Forecasting Case Study
Lecture 76Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 77Forecasting : Tools and Techniques
Section 6Royalty Management
Lecture 78Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 79Average Royalty Rates
Lecture 80Factors affecting Royalty Rates
Section 7Finance and Valuation Management
Lecture 81Training on Basic Finance | Understanding Financial Statement | 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 84Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 85Licensing Payment Schedule | Case Study
biopharma, biopharma business development, biopharma project management, Pharmaceutical Portfolio Management, Pharmaceutical Project Management Course
