SubscribeThe Drug Information Association will host a one-of-a kind meeting titled, “Bridging the Gaps between GCP, Clinical Trial Safety, and Postmarketing Vigilance,” from September 25-26, 2006 in Washington, DC.
This two-day event will address some of the regulatory compliance challenges facing international pharmaceutical and medical device companies.
Ever since international harmonization on safety reporting and risk management strategies were adopted by regulators worldwide, the current approval process for drugs and biological agents in the United States has come under intense scrutiny.
"Pre- and post-marketing vigilance, as well as Good Clinical Practice regulations, have undergone many changes over the past decade," said Theresa K. Musser, president of the DIA board of directors. "This conference will bring together both sides of the safety aisle to explore the relationship between harmonization efforts and compliance.
Representatives from the FDA, National Institutes of Health, international regulatory agencies, and industry will discuss issues surrounding global compliance, pre- and post-marketing regulatory requirements; safety-related US, EU, and Japan inspectional programs; EudraVigilance and EUDRACT systems; legal aspects of pre-marketing trials and post-marketing safety; local and global company SOPs; medical device initiatives occurring under Global Harmonization Task Force auspices; special issues in clinical trials; MedDRAź usage in clinical trials and premarketing safety; Institutional Review Boards, Data Safety Monitoring Boards, and human subject protection; FDA, EU Member State, and Japanese inspectional programs covering Good Clinical Practice; and effective compliance and the latest regulatory actions within and across ICH regions.
Early-bird registration runs through September 5, 2006. Register online at www.diahome.org. For more information, contact DIA Program Manager Ellen Diegel at (215) 442-6158 or Ellen.Diegel@diahome.org. Media interested in attending the event or arranging for pre- or post-event interviews should contact Heather Cable of Toplin & Associates, Inc. at (215) 793 4666 or heather@toplin.com.
Horsham, Pa - July 17, 2006