InstructorRoyed Training
TypeOnline Course
Student Enrolled1
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 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
Section 2Pharma and Biopharma R&D Project and Portfolio Management
Lecture 9Fundamental of Pharma R&D - Discovery to Commercialization Process
Lecture 10Investigational New Drug Application (INDA)
Lecture 11New Drug Application (NDA) 
Lecture 12Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 13Basic concept and understanding of the Generic Drug
Lecture 14Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 15Handling of orange book
Lecture 16Purple Book: Significance | Searching | Assignments
Lecture 17USFDA expedited programs
Lecture 18505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 19Advance Learning on 505B2 Pathway
Lecture 20Project Tracking in Drug Discovery Projects
Lecture 21Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 22Cycle Times (Stage or phase lengths)
Lecture 23Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 24Milestone chart
Lecture 25Project Terminations
Lecture 26Asset Tracking
Lecture 27Levels of Project and Portfolio Management
Section 3Concepts related to Project and Portfolio Management
Lecture 28Strategic Planning During Clinical Trials
Lecture 29LOE Strategies for Innovator Brands with case study
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology
Lecture 32In-Licensing Vs. Outlicensing
Lecture 33Licensing - Advance Learning 
Lecture 34Drug Repurposing
Lecture 35Advance study on Para IV Filing
Lecture 36Para IV Notices
Lecture 37Pay For Delay Strategy
Lecture 38REMS Strategic Planning 
Lecture 39Compulsory Licensing
Lecture 40Licensing & Technology Transfer
Lecture 41Pipeline in a Molecule
Lecture 42Patent Cliff
Lecture 43Due Diligence Activities in Pharmaceutical Licensing
Lecture 44Paediatric Exclusivity and Paediatric Study Plan Development
Section 4Pharma and Biopharma Strategic Project Management
Lecture 45Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 46Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 47Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 48Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 49Numerical SWOT Practical training
Lecture 50Modelling 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 51Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 52Forecasting : Tools and Techniques
Lecture 53Market Sizing & Forecasting Case Study
Lecture 54Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 55Average Royalty Rates
Lecture 56Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 57Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 58Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 59Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 60Types of Deals from Discovery to Commercialization
Lecture 61Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 62Licensing Payment Scheduling: Different Types
Lecture 63Basic Finance for Pharma and Biopharma Project Manager
Lecture 64Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 65Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 66Negotiation Skill Training for Project Management Professionals
Lecture 67Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 68Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 69Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 70Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 5Final Certification Examination