How to Avoid GCP Non-Compliance Issues in Your Clinical Trials

is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, June 22nd, 2010. For more details or to register please visit our site at www.fxconferences.com

Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.

In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.

From Emerging to Emerged: Clinical Development in Asia Pacific

Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.

The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.

This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.

From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

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