Promoting Excellence In Clinical Research: The Road to Compliance

Thank you for your interest.


We have reached capacity for this meeting.

No refunds will be given after Friday, September 11, 2009.

Case Western Reserve University

September 18, 2009



7:00  -  8:00 am    Registration, Breakfast, Welcome

8:00  -  8:05 am    Welcome and Introduction, Carol Fedor, President NEO ACRP

8:05  -  9:00 am    Keynote Speaker – Janette Collins-Mitchell “History of the FDA and the Bioresearch Monitoring (BIMO) Program.”

9:00 -  10:00 am   “Investigator Supervisory Responsibilities:  The Changing Landscape of FDA Expectations” - Liz Wool and Carol Fedor

10:00 - 10:30 am    BREAK

10:30 - 11:30 am    "FDA Inspections: What to Expect and How to Prepare" - Panel Discussion - Carol Fedor, Moderator

11:30 - 12:30 pm    “Consenting the Vulnerable Patient” - Carmen Paradis

12:30  - 1:30  pm    LUNCH

1:30  -  2:30  pm    Mock IRB Session

2:30  -  4:00 pm    Workshops

Workshop A: “Quality and Performance in Clinical Research:  Establishing a Quality Management System For Success.”  -  Liz Wool

Workshop B: “Applying the Principles of Project Management to Clinical Research.” - Sue Jasper and Lisa Prcela

4:00 pm - Close    Completion of Evaluation for Contact Hours and Dismissal.

This program is pending approval of 6.5 clinical research continuing education contact hours by ACRP and the California Board of Nursing. 

Purchase of Contact Hours will be available online after the event.  


Questions about registering?  Please email

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With thanks to our generous sponsors:

CRM Logo            CTSC logo


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Name Sales End Price Fee
Credit Card payments at the door Ended $50 $1.25