InstructorRoyed Training
TypeOnline Course
Price$390 USD / 18500 INR.
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Pharmaceutical Project Management online course

Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

Course Deliverable

Key learning area

Pharmaceutical Project Maangement Course by Royed Training

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. 
  • Flexible online final examination (Computer Based Test by secure mode)
  • Real life Case Study module will be provided along with the course, material. 

Graduation in any discipline.

  • Pharmaceutical & Bio-Pharmaceutical professionals seeking to enhance / update knowledge about pharmaceutical project management
  • Those moving into pharmaceutical project management 
  • Pharmaceutical R&D scientist and Regulatory Affairs Professionals 
  • 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

  1. Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination.
  2. 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 Project 
Lecture 4Project Management Constraint
Lecture 5Key to Project success
Lecture 6PERT, CPM, Critical Path, Project Diagram and its components
Lecture 7Qualities of a Good Project Leader
Section 2Pharma and Biopharma R&D Project and Portfolio Management
Lecture 8Fundamental of Pharma R&D - Discovery to Commercialization Process
Lecture 9Investigational New Drug Application (INDA)
Lecture 10New Drug Application (NDA) 
Lecture 11Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 12Basic concept and understanding of the Generic Drug
Lecture 13Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 14Handling of orange book
Lecture 15Purple Book: Significance | Searching | Assignments
Lecture 16USFDA expedited programs
Lecture 17505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 18Advance Learning on 505B2 Pathway
Lecture 19Project Tracking in Drug Discovery Projects
Lecture 20Project Benchmarking through a Consortium
Lecture 21Cycle Times (Stage or phase lengths)
Lecture 22Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 23Milestone chart
Lecture 24Project Terminations
Lecture 25Asset Tracking
Lecture 26Levels of Project and Portfolio Management
Section 3Concepts related to Project and Portfolio Management
Lecture 27Strategic Planning During Clinical Trials
Lecture 28LOE Strategies for Innovator Brands with case study
Lecture 29Evergreening - Patent Life Extension Strategies
Lecture 30Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology
Lecture 31In-Licensing Vs. Outlicensing
Lecture 32Licensing - Advance Learning 
Lecture 33Drug Repurposing
Lecture 34Advance study on Para IV Filing
Lecture 35Para IV Notices
Lecture 36Pay For Delay Strategy
Lecture 37REMS Strategic Planning 
Lecture 38Compulsory Licensing
Lecture 39Licensing & Technology Transfer
Lecture 40Pipeline in a Molecule
Lecture 41Patent Cliff
Lecture 42Due Diligence Activities in Pharmaceutical Licensing
Lecture 43Paediatric Exclusivity and Paediatric Study Plan Development
Section 4Pharma and Biopharma Strategic Project Management
Lecture 44Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 45Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 46Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 47Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 48Numerical SWOT Practical training
Lecture 49Modelling 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 50Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 51Forecasting : Tools and Techniques
Lecture 52Market Sizing & Forecasting Case Study
Lecture 53Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 54Average Royalty Rates
Lecture 55Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 56Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 57Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 58Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 59Types of Deals from Discovery to Commercialization
Lecture 60Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 61Licensing Payment Scheduling: Different Types
Lecture 62Basic Finance for Pharma and Biopharma Project Manager
Lecture 63Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 64Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 65Negotiation Skill Training for Project Management Professionals
Lecture 66Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 67Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 68Step By Step Implementation of Licensing Deal by Business Development Team 
Section 5Final Certification Examination