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New York Metropolitan Chapter of ACRP
presents our
2nd Annual Clinical Research Symposium
with support from NYU CTSI & NYCON CTSA Consortium
and our platinum chapter sponsor

September 24th & 25th, 2010
New York University

550 1st Avenue
New York, NY
Farkas Auditorium
September 24th, 2010
Centers for Excellence in Clinical Research
Keynote Speaker: Henry Spotnitz, MD
George H. Humphreys, II, Professor of Surgery
Vice Chair, Research and information Systems
Day 1: Three panel discussions focus on the goal of achieving site excellence:
Panel I – Is Your Clinical Research Site Good Enough to Be Accredited?
June Rae Merwin – Pfizer, Inc.
Marjorie Speers – AAHRPP
Carol Fedor – Center for Clinical Research at University Hospitals
George Gasparis – Columbia University Medical Center IRB
Panel II – National Cancer Institute (NCI) Designated Cancer Centers
Edward P. Gelmann – Columbia University Medical Center
Maryann Kral – Columbia University Medical Center
Linda K. Weiss – NCI
Panel III – Information Technology: Achieving Part 11 Compliance
Victoria Spendel – Cincinnati Children's Hospital Medical Center
Lisa Weiss – Shire Pharmaceuticals
Jaimie Lucove – Allscripts
Jules T. Mitchel – Target Health Inc.
Day 2: Focus on the FDA
September 25th, 2010
Session #1 9am-11am
Ask the FDA
This 2 hour panel discussion will have representatives from the drug and device sections of the FDA. The clinical research community is invited to ask questions of this expert panel.
Session #2 11:15am-1:15pm
The Changing Landscape of FDA Expectations: Investigator Supervisory Responsibilities
Liz Wool, BSN, CMT, CCRA
This important session will present the FDA expectations, as highlighted in FDA warning letters and guidance documents.
REGISTER BEFORE July 31st to get the EARLY BIRD RATES!!
(no refunds after 9/10/10)
Contact hours are administered by ACRP Global and incur a charge over and above the cost of the symposium. Two weeks prior to the event through two weeks after the event, a link to purchase contact hours will be activated on the chapter website. Email notifications will be sent when the link is active.
When & Where
550 First Avenue
New York
Friday, September 24, 2010 at 7:30 AM - Saturday, September 25, 2010 at 1:30 PM (ET)
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