TypeOnline Course
Price$390 / Rs. 19500
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Admission Process

Admission Process

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pharmaceutical project management course








Course Code: KPE-C-019

Course Title: Certificate Course in Pharmaceutical Project Management

Course Objective: The objective of this course is to impart knowledge and understanding of the Pharmaceutical Project management keeping in view of pharmaceutical, biotech and biosimilar industry in mind.

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


Frequently asked questions

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  • 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 3Program/Project Leadership versus Stage
Lecture 4Project Management Constraint
Lecture 5Key to Project Success
Section 2R&D Fundamental
Lecture 6R&D Process : Introduction
Lecture 7Investigational New Drug Application (INDA)
Lecture 8New Drug Application (NDA)
Lecture 9USFDA expedited programs
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Patents Vs. exclusivity 
Lecture 13Review on R&D Regulations
Section 3Portfolio Analysis
Lecture 14Introduction : Licensing and Technology Transfer
Lecture 15LOE Strategies for Innovator Brands with case study
Lecture 16Evergreening - Patent Life Extension Strategies
Lecture 17Some Important Termilogies
Lecture 18In-Licensing Vs. Outlicensing
Lecture 19Licensing - Advance Learning 
Lecture 20Terms of License
Lecture 21Are improvements licensed?
Lecture 22financial terms of a license and its total deal value
Lecture 23Milestone Payment
Lecture 24How are royalties structured in a license?
Lecture 25What accounts, inspection and audit provisions are in a license?
Lecture 26How is patenting dealt with in a license?
Lecture 27What warranties are in a license?
Lecture 28What competition law issues are there in licensing?
Lecture 29Overview of Strategic Alliances
Lecture 30Drug Repurposing
Lecture 31Pay For Delay Strategy
Lecture 32Pediatric Exclusivity - Case Study
Lecture 33Compulsory Licensing
Lecture 34Technology Licensing
Lecture 35Due Diligence Activities in Pharmaceutical Licensing
Lecture 36Rx-to-OTC switch
Lecture 37REMS Strategic Planning 
Section 4Project Management Tools and Techniques - PERT, CPM, Critical Path, Project Diagram and its components
Section 5Project Managment Job Aspects
Lecture 39Qualities of a Good Project Leader
Lecture 40Qualities of a Good Team Representative
Section 6Skills for effective project management
Lecture 41Project Tracking in Drug Discovery Projects
Lecture 42What to Track in project?
Lecture 43Project Benchmarking through a Consortium
Lecture 44Cycle Times (Stage or phase lengths)
Lecture 45Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 46Challenges to Milestone Dates
Lecture 47Project Terminations
Lecture 48Project Re-initiations
Lecture 49Asset Tracking
Lecture 50Levels of Project and Portfolio Management
Section 7Final Certification Examination