Linda Coleman's presentation, "Good Clinical Practice Essentials: What You Won't Learn from the Regulations," covers recent guidance from the FDA as well as inspection and audit findings.
Seattle, WA (PRWEB) April 17, 2013
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 2013 Clinical Research Conference – East. This year MAGI East will be held in Boston, MA, May 5-8, 2013.
Ms. Coleman’s presentation, “Good Clinical Practice Essentials: What You Won’t Learn from the Regulations,” provides unique insights into timely GCP topics. The presentation covers recent guidance from the FDA as well as inspection and audit findings. Using real-life studies packed with practical information, Ms. Coleman’s workshop lays the groundwork for many topics covered in the meeting. The presentation takes place Sunday, May 5th at 9:30 a.m.-12:00 p.m.
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 2013 Clinical Research Conference is one of the fastest growing events in the clinical research industry. The conference offers an exceptional networking environment with over 90 sessions and workshops that provide practical tips in a coherent program for operations, regulatory compliance, contracts and budgets. More information about the 2013 conference is available on the MAGI website.
For the latest on Quorum Review News and Events, visit http://www.quorumreview.com.
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 IRB review of drug and device trials 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 IRB services include 14 Board meetings each week plus expedited review, 24-hour site review turnaround, 36-hour amendment review turnaround, a secure web portal, and Smart Forms for online submissions. Quorum’s IRB service offerings include full study review in the US and Canada, a specialized Phase I team, and unique processes for post-approval and registry studies.