MEETINGS - Technology Acquisition: The Impact of Clinical Trials (US) October 1998:
This article was originally published in Clinica
Executive Summary
The Association for the Advancement of Medical Instrumentation will hold a meeting entitled Technology Acquisition: The Impact of Clinical Trials on October 9-10 in Baltimore. Representatives from the Health Care Financing Administration, the FDA and industry will discuss topics such as requirements for clinical trial design and outcomes; interpretation of safety and effectiveness in premarket approval process; and new guidelines for premarket approval of Class III devices by means of a product development protocol. The government's views on technology assessment and clinical trials will also be presented. Delegates will be able to participate in a mock clinical trial developed by the FDA to train its reviewers. For more information contact AAMI in the US. Fax: +1 703 525 1424.