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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
Section 2R&D Fundamental
Lecture 7R&D Process : Introduction
Lecture 8Investigational New Drug Application (INDA)
Lecture 9New Drug Application (NDA)
Lecture 10Basic concept and understanding of the Generic Drug
Lecture 11Abbreviated New Drug Application (ANDA) 
Lecture 12Handling of orange book
Lecture 13Complete Response Letter | Key understanding | Management and Action Plan
Lecture 14USFDA expedited programs
Lecture 15505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 16Concept of Authorized Generics
Lecture 17Exploratory IND Vs. Traditional IND
Lecture 18Orphan Drug Designation 
Lecture 19Advance Learning on 505B2 Pathway
Lecture 20Chemistry, Manufacturing & Controls 
Lecture 21Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 3Portfolio Analysis
Lecture 22Introduction : Licensing and Technology Transfer
Lecture 23LOE Strategies for Innovator Brands with case study
Lecture 24Evergreening - Patent Life Extension Strategies
Lecture 25Some Important Termilogies
Lecture 26In-Licensing Vs. Outlicensing
Lecture 27Licensing - Advance Learning 
Lecture 28Terms of License
Lecture 29Are improvements licensed?
Lecture 30financial terms of a license and its total deal value
Lecture 31Milestone Payment
Lecture 32How are royalties structured in a license?
Lecture 33What accounts, inspection and audit provisions are in a license?
Lecture 34How is patenting dealt with in a license?
Lecture 35What warranties are in a license?
Lecture 36What competition law issues are there in licensing?
Lecture 37Overview of Strategic Alliances
Lecture 38Drug Repurposing
Lecture 39Pay For Delay Strategy
Lecture 40Pediatric Exclusivity - Case Study
Lecture 41Compulsory Licensing
Lecture 42Technology Licensing
Lecture 43Due Diligence Activities in Pharmaceutical Licensing
Lecture 44Rx-to-OTC switch
Lecture 45REMS Strategic Planning 
Section 4Project Management Tools and Techniques - PERT, CPM, Critical Path, Project Diagram and its components
Section 5Skills for effective project management
Lecture 47Project Tracking in Drug Discovery Projects
Lecture 48What to Track in project?
Lecture 49Project Benchmarking through a Consortium
Lecture 50Cycle Times (Stage or phase lengths)
Lecture 51Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 52Challenges to Milestone Dates
Lecture 53Project Terminations
Lecture 54Project Re-initiations
Lecture 55Asset Tracking
Lecture 56Levels of Project and Portfolio Management
Section 6Advance Strategic Portfolio Management Skill Training
Lecture 57Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 58Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
Lecture 59Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 60Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 61Numerical SWOT Practical training
Lecture 62Numerical SWOT Practical training
Lecture 63Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 64Forecasting : Tools and Techniques
Lecture 65Market Sizing & Forecasting Case Study
Lecture 66Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 67Average Royalty Rates
Lecture 68Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 69Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 70Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 71Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 72Special Purpose Vehicle
Lecture 73Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 74Types of Deals from Discovery to Commercialization
Lecture 75Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 76Licensing Payment Scheduling: Different Types
Lecture 77Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 78Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 79Negotiation Skill Training for BD / Project Management Professionals
Lecture 80Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 81Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 82Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 83Due Diligence Activities in Pharmaceutical Licensing
Section 7Final Certification Examination