The mission of the United States Food and Drug Administration (FDA) is to Promote and Protect the Public Health.  The FDA promotes the public health by delivering to the market in an efficient and timely fashion new and novel drugs, devices and biologics that have been proven effective.  It also protects the public health by ensuring these products are safe when used as directed.

 

This webseminar reviews the definitions (or lack of) for adverse events within the medical device regulations, focusing on adverse device effects, and the challenges in understanding when events are reportable as adverse events and when they are not.  It covers both the reporting of Adverse Events associated with investigational devices as well as commercially available devices, as well as combination products and in-vitro diagnostic devices.  Also covered is the Institutional Review Boards' role in recording and reporting of adverse events.

 

Objectives:

Who Should Attend:

 

You will benefit from purchasing this event if you are a Vice President, Director or a Supervisor of the following departments at a medical device company.

This conference would also be of interest to law firms, and health policy consultants.

 

About the Presenter:

Douglas Albrecht, BSN, CCRA, President, Valiscent Clinical, Inc.

 

Douglas Albrecht has spent his clinical research career working for both large and small medical device and diagnostic companies designing and managing IDE clinical trials and non-significant risk clinical trials.  Mr. Albrecht has participated in the pre-IDE, IDE and PMA processes by working with the FDA to develop successful strategies leading to the initiation and successful completion of IDE clinical trials and eventually successful marketing application submissions.  Since starting Valiscent Clinical in 2006, Mr. Albrecht has consulted for and assisted a number of medical device companies with the management and successful completion of their clinical trials.