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With the release of the ICH E6(R2) GCP guideline in November of 2016 and regulatory agencies' expectations of a quality management system (QMS) approach to the conduct of regulated clinical trials, many sponsors are quickly adapting such an approach. At this time, the same cannot be said of many clinical research sites. This presentation will describe a clinical site that chose to apply a QMS approach, along with the trials and tribulations it faced along the way. We will describe the actual process, including the difficulties and challenges faced. The presentation will also outline the positive outcomes experienced since applying such an approach and what future activities will be needed to ensure maintenance of the QMS approach. 209
Presenter: Marcus Stone, PhD, ACRP-CP, Director of Clinical Research, Spine Institute of Louisiana Foundation
Presenter: Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP, TIACR, President and CEO, Norwich Clinical Research Assoc., Ltd.
Good Laboratory Practice (GLP) studies can be more than just one of the boxes you need to check off in order to receive regulatory approval to initiate a human clinical trial with your company's’ new medical device. Large animal GLP studies are mainly used to support the filing of IDE/ITAs, but they can be designed to provide additional valuable information that can increase the chances of human trial success. GLP studies are traditionally designed to provide safety and efficacy data with an emphasis on safety, on the use of a medical device, but these studies can also be designed to collect information for areas such as reimbursement, clinical adoption, human factors, risk evaluation and mitigation, and transportation and storage logistics; all important factors in the successful development of any new medical device. It is all about making sure that you maximize every opportunity to collect information related to your company’s new medical device. 213
Presenter: Michael Jamieson, DRSc, , Advisor, Research & Innovation Partnerships, Queens University
This presentation will provide an overview of hypersensitivity reactions to metal, review of the evidence and findings from a recent qualitative study on the experiences of people with metal hypersensitivity. 215
Presenter: Dzifa Dordunoo, PhD, MSN, BSN, RN, Assistant Professor, University of Victoria