Project Management in Drug Development: Phase III to Commercialization and Beyond

COURSE DESCRIPTION
Discover how 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 to successfully transition from Phase III to commercialization and avoid costly delays.

INSTRUCTOR
Stephen M. Perry, PMP, Kymanox

COST
$990

PROFESSIONAL DEVELOPMENT UNITS (PDUs) GIVEN FOR COMPLETING THE COURSE:
14 PDUs (see www.pmi.org for more details)

DATES
December 7-8, 2009 8:30 AM – 4:30 PM  

WHERE
Room 123 at BTEC,
850 Oval Drive
Raleigh, NC 27606

PDF INFORMATIONAL DOCUMENTS
Course Description
Course Summary
Course Agenda
BTEC Information Sheet

COURSE DETAILS

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.  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 individuals who hold 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	15 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 capable Kymanox staff for all of your technical project management needs

SIGNUP

There are two ways to sign up:

Signup for the Dec 7-8, 2009 session on our KymaSTORE website using your credit card.

OR

REGISTRATION EMAIL/ CHECK

Send an email to reserve your seat to info@kymanox.com with your name, phone number, email and the session you would like to attend.

Mail your check for $990 to:

Kymanox
Attn: Course Coordinator
2220 Sedwick Road, Suite 201
Durham, NC 27713

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

"Small projects need much more help than great ones." - Dante Alighieri