Seattle, WA (PRWEB) April 25, 2014
Quorum Review IRB, the industry leader in central IRB services, announces Director of Regulatory Affairs and General Counsel Linda Coleman, JD, CIP, CHC, CHRC, as a presenter at MAGI’s 2014 Clinical Research Conference – East. This year MAGI East will be held at the Loews Hotel in Philadelphia, PA, May 4-7, 2014.
Ms. Coleman’s presentation, “Master Class: Good Clinical Practice,” covers important GCP topics, with recent FDA guidance, and inspection and audit findings. This workshop lays the groundwork for the topics covered in the meeting, and attendees are encouraged to bring their own GCP questions and real world dilemmas for an engaging discussion. The presentation takes place Sunday, May 4th with Part One at 9:30 a.m.-12:00 p.m. and Part Two from 1:30 p.m.-4:45 p.m. Ms. Coleman adds, “I am looking forward to presenting at MAGI East as it provides a wonderful opportunity to apply an IRB’s experience to the research community in a practical way.”
Ms. Coleman has over a decade of legal expertise in clinical trial research and regulatory oversight. She joined Quorum Review in 2007 as the Director of Regulatory Affairs and today continues to serve that role in addition to the role of General Counsel, which she assumed early in 2011. In April 2012, Ms. Coleman was honored by Puget Sound Business Journal as “Outstanding Corporate Counsel for a Small Business” (<1000 employees), recognizing her legal expertise in research matters and contribution to education.
MAGI’s 2014 Clinical Research Conference is one of the most visible events in the clinical research industry. The conference offers an exceptional networking environment with a large variety of sessions and workshops that provide practical tips in a coherent program for operations, regulatory compliance, contracts and budgets. More information about the 2014 conference is available on the MAGI website.
About Quorum Review IRB
Quorum Review is an independent institutional review board fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and has been providing ethics review of human clinical research since 1992. Quorum oversees research in accordance with U.S. and Canadian human subject research protection regulations and guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.
Quorum’s best-in-class service and support includes 15 Board meetings each week, plus expedited review, 24-hour site review turnaround, 36-hour amendment review turnaround, a secure web portal, and SmartForms for online submissions. Quorum’s service offerings include full study review in the US, as well as internationally; a specialized Phase I team; institution-specific support; and efficient processes for minimal risk studies.