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Event Details
Comparing and Contrasting Safety Reporting in Drug and Device Trials
Speaker: Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP. President, CEO of NCRA
Ms. Truax-Bellows is a certified monitor and registered good clinical practice auditor with extensive experience of regulated research within the pharmaceutical and medical devices.
November 4th, 2009
Lenox Hill Hospital
130 W. 77th (between Park and Lex)
William Black Hall, 2nd Floor, Theater Room
Brief Program Description
This program is designed to assist the research professional in identifying and managing safety reporting FDA requirements for both medical device and drug clinical studies. It will assist the participant in identifying the differences and similarities for safety reporting between the two different types of studies.
Program Objectives:
1. The participant should be able to interpret the various definitions and reporting requirements for drug and device studies
2. The participant should be able to distinguish differences between drug and device reporting requirements and best practices
3. The participant should be able to explain current regulatory agency activities that impact safety reporting today
Program Agenda: Registration and Networking 6:00-6:40pm;
Chapter elections and meeting 6:40-7pm;
Educational Program & Q&A 7:00 – 8:30pm
Target Audience: All research professionals
When & Where
Lenox Hill Hospital
130 East 77 Street (between Lexington and Park Avenues)
Theater Room, 2nd Floor
New York,
NY NY
Wednesday, November 4, 2009 from 6:00 PM to 8:30 PM (ET)
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Hosted By
NY Metropolitan Chapter of ACRP
