An Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects
Clinical studies are included in almost all new devices presented for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) and may also apply to the approximately 10% of devices under premarket notification that contain clinical data. ANSI/AAMI/ISO 14155:2011 addresses the practical aspects of how to plan clinical investigations conducted in human subjects and defines procedures for the design, conduct, recording, and reporting of a clinical study. The latest version of the standard has been updated to provide step-by-step guidance on the creation and execution of a clinical study.
This webinar addresses good clinical practice in clinical investigations of medical devices for human subjects using ISO 14155 as a guide. Dr. Matthew Tarosky and Dr. Kimber Richter of the FDA and Ms. Jennifer Kerr of the MED Institute, Inc., present in a novel format that will build on each presenter’s experiences. Dr. Tarosky covers frequent problems seen during FDA inspections at clinical sites, both inside and outside the U.S. Dr. Richter explains the history of the new standard and how the FDA encourages its usage. Ms. Kerr reviews the content of the standard and offer best practices in conducting a study — whether you are a researcher, sponsor, or clinical research organization (CRO).
Don’t miss this opportunity to hear directly from the FDA and industry on clinical trials and how this new standard should be applied!
| WHO SHOULD PURCHASE | |
| This webinar is designed for clinical researchers, investigators, research facilities, research coordinators, CROs, physicians, scientists, quality assurance professionals, regulatory affairs professionals, regulators, and any other individuals involved in testing of medical devices. | |
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM AT-A-GLANCE
- FDA inspections at clinical sites
- Frequent problems
- International data and multi-national studies
- History of the ANSI/AAMI/ISO 14155:2011 standard
- Comparison with good clinical practices (GCPs)
- FDA’s plan for recognizing the standard
- Content of the ANSI/AAMI/ISO 14155:2011 standard
- New and modified definitions
- Documentation and planning, useful tools
- Roles and responsibilities of the sponsor, monitor, and principal investigator
- Best practices when conducting a study
- Perspectives of the researcher, sponsor, and CRO
SPEAKERS
- Matthew J. Tarosky, PharmD, EJD, Acting Director, Division of Bioresearch Monitoring, Office of Compliance, CDRH, FDA
- Kimber C. Richter, MD, Deputy Director of Medical Affairs, Office of Compliance, CDRH, FDA
- Jennifer Kerr, MS, CCRA, RAC, Vice President, MED Institute, Inc.
WEBINAR CD
Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.
- $295 for webinar registrants
- $395 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
AAMI Webinar CD
Overview 14155
PO Box 0211
Annapolis Junction, MD 20701-0211