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UPCOMING LIVE SEMINARS
 
Auditing Techniques for Clinical Research Professionals
October 23-24, 2014
San Francisco, CA
Monitoring Clinical Drug Studies: Advanced
November 13-14, 2014
San Francisco, CA






CRC & PI Current Practice Update: Impact of the FDA BIMO Program

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description

The FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO inspections program. This includes conducting inspections and other assessments earlier in the development of a potential product to build quality into the clinical trial upfront rather than assessing it at trial completion. From this initiative, the FDA has generated new guidance and regulation that directly affect the performance of the research investigator and the research coordinator. The initiative is a dynamic process and this web seminar tracks the updates that directly affect the investigator and study staff. Examples of how to implement the agency requirements and recommendations into current practices and specific projects are also covered.

Learning Objectives

  • Examine industry regulatory updates that impact the role of the Clinical Research Coordinator
  • Integrate strategies for determining appropriate role delegation and documentation specific to a study project
  • Apply tools and resources

Who Should Attend

  • Clinical Research Coordinators
  • Investigators
  • Site Managers
  • Quality Assurance Personnel
  • Clinical Research Associates

Instructor

This course will be taught by one of the following instructors:

Linda Carter, R.N., B.S.N.

Nikki Christison, B.S., C.C.R.A.

Jeanne Morris, B.S., MT (ASCP)

Click here for complete trainer biographies 

Registration Fees

$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, please call 1-800-856-2556 for pricing.

Accreditation Information

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#: 0778-0000-13-006-L01-P. Released: 4/13. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.