Seattle, WA (PRWEB) June 12, 2012
Quorum Review IRB‘s General Counsel and Director of Regulatory Affairs will present an interactive session on minimal risk research at this year’s DIA 48th Annual Meeting on Tuesday, June 26, held in Philadelphia, PA.
Linda Coleman, JD, CIP, CHC, CHRC, will lead the expert session “Non Interventional Minimal Risk Research: a 360-degree Perspective.” The panel will provide today’s critical perspectives on FDA compliance and OHRP regulatory requirements for post-approval non-interventional studies, registries, safety-surveillance, and REMS, as seen through the viewpoints of the Institutional Review Board, clinical trial administrators, and research sites.
Using relevant case studies, the expert panel will also shed light on stakeholders’ views, including patients and caregivers, physicians administering such research, and those responsible for healthcare payment.
Ms. Coleman will be joined by an esteemed panel of ethics review experts from the field, including: Ann Meeker-O'Connell, Acting Associate Director, Risk Science, Intelligence, and Prioritization, Office of Scientific Investigations, CDER, FDA, Kathleen Mandziuk, MPH, Senior Scientific Affairs Director, PRA, and Lindsay Boyer Crampton, CCRP, Project Manager, Global Late Stage Research, PPD.
Ms. Meeker-O’Connell joined the Office of Scientific Investigations in the Office of Compliance, Center for Drug Evaluation and Research at FDA in March 2010. In OSI, she serves as Acting Associate Director for Risk Science, Intelligence, and Prioritization, leading a team developing risk-based analytic tools for pre- and post-marketing compliance activities. Ms. Meeker-O’Connell is actively involved in a range of clinical trial policy matters, including innovative models for clinical trial oversight and implementation of the Food and Drug Administration Amendments Act of 2007, Title VIII.
Ms. Mandziuk comes to the panel with over 15 years of managing clinical late phase study solutions for biotechnology, pharmaceutical, and medical device companies. In her current role of Senior Scientific Affairs Director at PRA, a global CRO headquartered in Philadelphia, PA, she supports clients across all phases of pharmaceutical and biotech drug development and clinical trial research by combining therapeutic and operational expertise with local knowledge.
Ms. Crampton provides operational oversight for pregnancy registries/observational studies, Risk Evaluation & Mitigation Strategy (REMS) programs and other post marketing safety studies at PPD, a leading global CRO providing drug discovery, development and lifecycle management services, based in Wilmington, NC.
The afternoon session (#256) will be held at 1:30-3:00 pm EST, Tuesday, June 26th, in Room 199b. More information can be found on the DIA Meeting Program website within the “Clinical Safety and Pharmacovigilance” track, and attendees will be eligible for IACET CEUs, as outlined in the final program.
Held in Philadelphia, PA, from June 24-28, the DIA Annual Meeting is a four day networking event. Participants from around the world gather to learn from over 7,500 experts and professionals from the pharmaceutical, biotechnology, medical device and healthcare-related industries. Highlights of the event include 22 Tracks featuring over 270 educational opportunities, white paper showcase, and over 500 exhibiting companies.
Quorum Review will be a featured exhibitor at the DIA 2012 conference, and welcomes visitors to booth #1624 to discuss their projects and questions related to ethics review and the IRB.
About Quorum Review IRB
Quorum Review IRB is an independent ethics review board fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and has been providing ethics review of drug and device trials since 1992. Quorum Review IRB oversees research in accordance with U.S. and Canadian human research subject 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 and support includes 13 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 Review’s comprehensive IRB offerings include full study review in the U.S. and Canada, a specialized phase I team, and unique processes for post-approval and registry studies.