TypeOnline Course
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Price$390 / Rs. 19500
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Admission Process

Admission Process

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pharmaceutical project management course

Introduction

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Duration

Syllabus

Admission

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Resources

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

FAQ RELATED TO THE COURSE

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ADMISSION PROCESS

  • 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 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 9Basic concept and understanding of the Generic Drug
Lecture 10Abbreviated New Drug Application (ANDA) 
Lecture 11Handling of orange book
Lecture 12Complete Response Letter | Key understanding | Management and Action Plan
Lecture 13USFDA expedited programs
Lecture 14505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 15Concept of Authorized Generics
Lecture 16Exploratory IND Vs. Traditional IND
Lecture 17Orphan Drug Designation 
Lecture 18Advance Learning on 505B2 Pathway
Lecture 19Chemistry, Manufacturing & Controls 
Lecture 20Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 3Portfolio Analysis
Lecture 21Introduction : Licensing and Technology Transfer
Lecture 22LOE Strategies for Innovator Brands with case study
Lecture 23Evergreening - Patent Life Extension Strategies
Lecture 24Some Important Termilogies
Lecture 25In-Licensing Vs. Outlicensing
Lecture 26Licensing - Advance Learning 
Lecture 27Terms of License
Lecture 28Are improvements licensed?
Lecture 29financial terms of a license and its total deal value
Lecture 30Milestone Payment
Lecture 31How are royalties structured in a license?
Lecture 32What accounts, inspection and audit provisions are in a license?
Lecture 33How is patenting dealt with in a license?
Lecture 34What warranties are in a license?
Lecture 35What competition law issues are there in licensing?
Lecture 36Overview of Strategic Alliances
Lecture 37Drug Repurposing
Lecture 38Pay For Delay Strategy
Lecture 39Pediatric Exclusivity - Case Study
Lecture 40Compulsory Licensing
Lecture 41Technology Licensing
Lecture 42Due Diligence Activities in Pharmaceutical Licensing
Lecture 43Rx-to-OTC switch
Lecture 44REMS Strategic Planning 
Section 4Project Management Tools and Techniques - PERT, CPM, Critical Path, Project Diagram and its components
Section 5Project Managment Job Aspects
Lecture 46Qualities of a Good Project Leader
Lecture 47Qualities of a Good Team Representative
Section 6Skills for effective project management
Lecture 48Project Tracking in Drug Discovery Projects
Lecture 49What to Track in project?
Lecture 50Project Benchmarking through a Consortium
Lecture 51Cycle Times (Stage or phase lengths)
Lecture 52Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 53Challenges to Milestone Dates
Lecture 54Project Terminations
Lecture 55Project Re-initiations
Lecture 56Asset Tracking
Lecture 57Levels of Project and Portfolio Management
Section 7Advance Strategic Portfolio Management Skill Training
Lecture 58Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 59Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
Lecture 60Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 61Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 62Numerical SWOT Practical training
Lecture 63Numerical SWOT Practical training
Lecture 64Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 65Forecasting : Tools and Techniques
Lecture 66Market Sizing & Forecasting Case Study
Lecture 67Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 68Average Royalty Rates
Lecture 69Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 70Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 71Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 72Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 73Special Purpose Vehicle
Lecture 74Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 75Types of Deals from Discovery to Commercialization
Lecture 76Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 77Licensing Payment Scheduling: Different Types
Lecture 78Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 79Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 80Negotiation Skill Training for BD / Project Management Professionals
Lecture 81Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 82Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 83Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 84Due Diligence Activities in Pharmaceutical Licensing
Section 8Final Certification Examination