Phase I Study Management

Course Description______________________________

Because the early life of a compound is dependent on the data and analysis derived from Phase I studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore well honed project management skills that can address the unique issues associated with Phase I studies are needed.

This session will examine the importance of Phase I studies in drug development, the issues commonly associated with conducting a Phase I study from both a sponsor perspective and provide project management best practices specific to overseeing a Phase I study.

Learning Objectives______________________________

Define Phase I Studies
Examine the importance of Phase I data in Clinical Development
Review general considerations for a Phase I Study
Describe the attributes of an effective Phase I Unit
List project management best practices specific for Phase I clinical trials

Who Should Attend_______________________________

Project Managers
Study Directors
Site Monitors

Instructor _______________________________________

Erica Elefant, R.N., B.S.N., M.S.W.

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Course Length and Time___________________________

1.5 hours; 1:00 – 2:30 p.m. Eastern

Course Dates ____________________________________

June 22, 2010

Fee____________________________________________

$595

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, call 1-800-856-2556 for pricing.

Accreditation___________________________________

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 778-000-09-061-L04-P. Released: 6/10..