Copernicus Group IRB Chairperson, Glenn Veit, speaks at DIA
Veit Presented Perspectives of IRB Process in Phase I Studies

WASHINGTON, DC, August 14, 2010 /24-7PressRelease/ -- Copernicus Group IRB (CGIRB) Chairperson, Glenn Veit, spoke at the Drug Information Association 46th Annual Meeting. Along with colleagues from Duke University Medical Center and Pfizer, Inc., Mr. Veit presented a session titled "Three Perspectives of the IRB Process in Phase I Studies Conducted in an Academic Setting." The session focused on how obtaining Institutional Review Board (IRB) approval to conduct a Phase I clinical trial presents unique challenges for an academic site conducting the study, as well as the pharmaceutical sponsor, and the IRB.

"Having the opportunity to speak with Barry Mangum of Duke University Medical Center and Anne Cropp of Pfizer was professionally rewarding," said Veit. "Our session discussed three challenges ‐ operational, IRB approval process, and oversight ‐ through the lens of three stakeholders ‐ an academic site, the sponsor, and the IRB."

As the IRB representative for the session, Veit provided perspective by identifying the issues that make Phase I research at academic institutions different. He then explained how the IRB uses regulations and the principles of the Belmont Report to resolve those issues in a way that enhances subject safety and assists the sponsor and investigator in meeting goals for the research.

Veit summed up the session saying, "Hopefully the take‐away message is for people to better understand both the importance of IRB review and the potential benefits for all stakeholders."

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