Course Description______________________________
The FDA recently revamped its website in an effort to help make information more readily available to users. To speed the process of accessing information, it has now been classified by subject matter for easier retrieval, with associated subjects combined in sections. The site’s updated design and navigation allow uniformity across the site and content has been reviewed for relevance, with unnecessary and obsolete information removed. In addition, new information that is useful for clinical research professionals is now accessible.
This session will review the FDA website for information that will be useful for the clinical research professional in conducting their daily activities. Particular focus will be placed on facilitating location of key information, discussion of its relevance, and utilization of identified information as a tool for enhancing research compliance.
Learning Objectives______________________________
Identify and locate the websites for the Food and Drug Administration’s (FDA’s) different Centers and Offices and discuss the role of each as it pertains to human subject research
Review FDA databases for information on regulations, guidance, enforcement actions, updates, and FAQs
Discuss how these resources can be used to develop and strengthen your role in initiating and conducting clinical research
Who Should Attend_______________________________
Clinical Quality Assurance Professionals
Clinical Research Associates
Project Managers
Investigators
Study Coordinators
GCP-Focused Regulatory Affairs Professionals
Instructor _______________________________________
Elizabeth Ronk Nelson, M.P.H.
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Course Length and Time___________________________
2 hours; 1:00 – 3:00 p.m. Eastern
Course Dates ____________________________________
June 30, 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 2 hours (0.2 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#: 778-000-09-060-L04-P. Released 2/10.
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For more information, contact Naila Ganatra at (215) 413-2471.