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Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices
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Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices

8/26/2015 to 8/28/2015
When: August 26-28, 2015
Where: The Hilton Los Angeles Airport (LAX)
5711 West Century Boulevard
Los Angeles, California  90045
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin
610-648-7550

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Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices

Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.

The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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