TRAINING

COURSE DESCRIPTION

An intensive two-day program for project managers or individuals with project management responsibilities in the pharma and biotech industries. 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. Learn how to create a target product profile that highlights the key features of the end-product.

WHAT PAST ATTENDEES HAVE SAID ABOUT THE COURSE:

Every attendee said they would recommend the course to others!

WHY SHOULD YOU 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.

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.

ATTEND AND YOU WILL LEARN

By the end of this course, students 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.

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/Program Manager
• Clinical Operations Manager
• Clinical Trial Manager
• Clinical/Medical Affairs Director
• Regulatory Affairs Manager
• Portfolio Manager
• Project Coordinator
• Plant Manager

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 capable staff for all of your technical project management needs

Also check out our training on Technology Transfer

Questions? Please call Kymanox at: +1-919-246-4896