Kymanox Project Management Course

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The Kymanox PROJECT MANAGEMENT TOOLKIT

FOR PHASE III AND COMMERCIAL BIOPHARMACEUTICAL DEVELOPMENT


General Course Information

An intensive two-day program for project managers or individuals with project management responsibilities in the pharma and biotech industries.

What is covered?

  • Learn to use the fundamentals of project management for drug development projects
  • Learn what skills are needed to implement, monitor, and control these types of projects
  • Learn how to create a project team and develop project objectives, plans, and timelines
  • Get useful templates to help manage your projects right away
  • Earn 14 PDUs toward PMI’s PMP certificate

Where is this Course?

 Golden LEAF BTEC

850 Oval Drive
Raleigh, NC 27695

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Why You Should Attend

As a new drug candidate enters late-stage clinical development, project managers must shift their focus from development to preparing to enter the marketplace.  A few of the challenges associated with Phase III and Commercialization include regulatory submission, manufacturing scale-up, and promotional launch. In order to successfully transfer from Phase III to Commercialization, project managers must learn how to apply the fundamentals of cross-functional project management to these later stages of drug development. Particular skills are needed to effectively implement, monitor, and control late stage projects.

By following the procedures and using the tools and templates provided, this course will allow you to successfully manage late-stage drug development projects and avoid costly delays during the shift from Phase III to Commercialization.

Who Should Attend

Any individual who holds project or program management positions and/or individuals with project management responsibilities in the pharmaceutical and biotechnology industries, including but not limited to the following job functions:

  •   Project and Program Manager
  •   Manufacturing Operations Director
  •   Clinical Trial and Medical Affairs Director
  •   Project Management Office Director
  •   Regulatory Affairs and Quality Manager
  •   Portfolio Manager
  •   Project Coordinator
  •   Plant Manager

How To Register

Email us at sales@kymanox.com or call +1 919.246.4896


Course Outline

Course Instructor

Stephen M. Perry, Project Management Professional – CEO, Kymanox

Day 1 – Phase III

Lecture 1. Introduction

  • Introduce course & key objectives
  • Outline drug development process
  • Define key project management concepts & terms

Lecture 2. The Project Team

  • Determine which departments and/or disciplines should be represented
  • Communicate with stakeholders

Lecture 3. Updating the Target Product Profile (TPP)

  • Identify what has changed from the original TPP
  • Identify what factors must be considered for the TPP

Lecture 4. Developing Project Objectives

  • Understand importance of defining project objectives
  • Develop & examine typical Phase III project objectives
  • Understand relationships between project objectives

Lecture 5. Developing the Project Plan

  • Develop the Work Breakdown Structure
  • Identify critical path & develop sequence of activities
  • Resource the plan & manage risks

Day 2 – Commercialization

Lecture 6. Developing the Timeline & Budget

  • Create timeline & use timeline tracking tools
  • Develop the budget & use budget tracking tools

Lecture 7. Project Implementation, Monitoring & Control

  • Respond to risk & assure quality
  • Outline decision making process
  • Utilize monitoring tools & communicate progress

Lecture 8. Transition from Phase III to Commercialization

  • Identify the stakeholders
  • Ensure a successful “hand off”

Lecture 9. Summing It All Up

  • Analyze the state of project management
  • Anticipate future trends in project management
  • Review templates from the Kymanox PM Toolkit:
    • Project Charter
    • Stakeholder Analysis and Team Roster
    • Kick-off Meetings
    • Agendas, Minutes, Action Items, & Decisions
    • Risk Management Plan
    • Communication Plan
    • Quality and Change Management Plans
    • Weighted Grid Decision Making
    • Closeout

After this course you will be able to…

  • Select the right cross-functional team to ensure project success
  • Effectively communicate with internal and external stakeholders and prevent communication breakdowns
  • Develop useful project objectives and project plans
  • Apply risk management strategies when developing project objectives and making risk-based decisions
  • Create and manage an achievable timeline and budget
  • Successfully transition from Phase III to commercialization and avoid costly delays

Attend and you will receive…

  • 9 in-depth lectures on the specifics and mechanics of technology transfer
  • Interactive discussions, quizzes, and activities to reinforce the course content
  • Detailed list of documents and editable templates required for successful management of late-stage drug development projects
  • Access to an instructor with first-hand project management and drug development experience
  • Support of Kymanox’s capable staff for all of your technical project management needs


How To Register

Email us at sales@kymanox.com or call +1 919.246.4896


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