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pharmaceutical project management course







Course Code: KPE-C-019

Course Title: Certificate Course in Pharmaceutical Project Management

Pharmaceutical Project Management course trains professionals in advance project, portfolio and strategic management.

This online Pharmaceutical/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.

Who should attend?
  • Pharmaceutical & Bio-Pharmaceutical professionals seeking to enhance / update knowledge about pharmaceutical project management
  • Those moving into pharmaceutical project management 
  • Pharmaceutical R&D scientist 
  • Anyone who will be working at portfolio management projects of pharmaceutical companies

1. Orientation to practical understanding in the entire scientific approach behind project management and its key learning ares

2. Simulation to real life drug discovery project management, portfolio management, formulation development (F&D) management in parenteral, solid and semi solid dosage form and novel drug delivery system.

3. Access to Project management case studies and flow charts

4. Access to Pharmaceutical Case Studies related to project management

5. Attend Live Lectures of all different chapters / study content.

1 Month 

Pharmaceutical Project Management course is structured as follows:

  • Strategic look into pharma project management.
  • Turns to the key links of pharma projects with pharma business strategy.
  • Introduction to Project Management, terminologies and advance content of the project management. 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
  • Cutomized formats, charts, logs for detailed project management systems and controls. Practical Training on documentation
  • Handling of IT system and Project software

  • Upon admission you will be providing the user id and password to access all the content online.
  • You will also be receiving the soft copy of the e-module (which you can download from your dashboard).

Course registrant will be receiving hard copy of the printed module within India only. 

International participant will be receiving pdf modules (books) by email.

What is the importance of project manager in pharmaceutical industry?

Drug development is unpredictable The course of drug development is unpredictable and therefore it is critical to have realistic expectations for any given project. There are inherent difficulties in running a drug development successfully and the larger the project the more numerous potential problems can be. Accounting for the factors that can stand in the way of a project’s success and being able to take an objective view of the strategies required is a demanding, but necessary task.

Regardless of the amount that a pharmaceutical company decides to invest in its new drug pipeline, there is no chance of success unless a project is effectively managed. At present the pharmaceutical industry is under pressure to improve its productivity, as the number of new products reaching the market has been on the decline for a number of years. The productivity decline has led to many observers believing that the industry requires a new approach to the way in which it runs its projects.

It is these circumstances that have led to the rise of project managers in the pharmaceutical industry. Project managers are able to apply past experience to ongoing projects in order to solve problems in a practical manner whilst also being able to develop new approaches to resolve project-specific issues. Although it is impossible to predict every factor that will affect a project, by being proactive the major issues can be identified. Furthermore, any preconceptions can be challenged and alternative scenarios can be devised.

Focus on Pharmaceutical licensing

Alliances and collaborations are playing a greater role in drug development. Companies are finding that by licensing in compounds they are able to supplement their pipelines. Over a quarter of the sales of the top 50 pharmaceutical companies were derived from in-licensed drugs and also huge royalities companies received from outlicense molecules. This approach allows the parties to benefit from the commercial and technical strengths of the other organization and the sharing of risk. Yet once again, careful management of a project is required if it is to have any chance of success. Poor project management could negate all the advantages that have been gained through potential collaboration.

Section 1Introduction to Project Management
Lecture 1Definition Review
Lecture 2Difference between Project and Program
Lecture 3Role and Responsibility of Project Leader
Lecture 4Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 5Qualities of the Pharmaceutical Project Manager
Lecture 6Review Test
Lecture 7Introduction to Pharma Project Management  - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 8Terminologies of Pharmaceutical Project Management 
Lecture 9Project Tracking 
Lecture 10Asset Tracking 
Section 2R&D Fundamental
Lecture 11R&D Process : Introduction
Lecture 12Investigational New Drug Application (INDA)
Lecture 13New Drug Application (NDA)
Lecture 14Basic concept and understanding of the Generic Drug
Lecture 15Abbreviated New Drug Application (ANDA) 
Lecture 16Handling of orange book
Lecture 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18USFDA expedited programs
Lecture 19505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 20Concept of Authorized Generics
Lecture 21Exploratory IND Vs. Traditional IND
Lecture 22Orphan Drug Designation 
Lecture 23Advance Learning on 505B2 Pathway
Lecture 24Chemistry, Manufacturing & Controls 
Lecture 25Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 26Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 27Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 28Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 29Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 30Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 3Portfolio Analysis
Lecture 31Introduction : Licensing and Technology Transfer
Lecture 32LOE Strategies for Innovator Brands with case study
Lecture 33Evergreening - Patent Life Extension Strategies
Lecture 34Some Important Termilogies
Lecture 35In-Licensing Vs. Outlicensing
Lecture 36Licensing - Advance Learning 
Lecture 37Terms of License
Lecture 38Are improvements licensed?
Lecture 39financial terms of a license and its total deal value
Lecture 40Milestone Payment
Lecture 41How are royalties structured in a license?
Lecture 42What accounts, inspection and audit provisions are in a license?
Lecture 43How is patenting dealt with in a license?
Lecture 44What warranties are in a license?
Lecture 45What competition law issues are there in licensing?
Lecture 46Overview of Strategic Alliances
Lecture 47Drug Repurposing
Lecture 48Pay For Delay Strategy
Lecture 49Pediatric Exclusivity - Case Study
Lecture 50Compulsory Licensing
Lecture 51Technology Licensing
Lecture 52Due Diligence Activities in Pharmaceutical Licensing
Lecture 53Rx-to-OTC switch
Lecture 54REMS Strategic Planning 
Section 4Skills for effective project management
Lecture 55Project Tracking in Drug Discovery Projects
Lecture 56What to Track in project?
Lecture 57Project Benchmarking through a Consortium
Lecture 58Cycle Times (Stage or phase lengths)
Lecture 59Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 60Challenges to Milestone Dates
Lecture 61Project Terminations
Lecture 62Project Re-initiations
Lecture 63Asset Tracking
Lecture 64Levels of Project and Portfolio Management
Section 5Advance Strategic Portfolio Management Skill Training
Lecture 65Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 66Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
Lecture 67Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 68Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 69Numerical SWOT Practical training
Lecture 70Numerical SWOT Practical training
Lecture 71Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 72Forecasting : Tools and Techniques
Lecture 73Market Sizing & Forecasting Case Study
Lecture 74Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 75Average Royalty Rates
Lecture 76Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 77Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 78Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 79Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 80Special Purpose Vehicle
Lecture 81Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 82Types of Deals from Discovery to Commercialization
Lecture 83Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 84Licensing Payment Scheduling: Different Types
Lecture 85Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 86Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 87Negotiation Skill Training for BD / Project Management Professionals
Lecture 88Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 89Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 90Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 91Due Diligence Activities in Pharmaceutical Licensing
Section 6Final Certification Examination