Adverse Events 101

Rick Kingston, President, Regulatory and Scientific Affairs If you’re wondering exactly what constitutes an adverse event (AE), you’ve come to the right place. In general terms, an adverse event is an experience associated with the use of a product that is or could be considered adverse or unwanted. They typically fall into three categories: Toxicology-related adverse events – When humans …

Dr. Kingston Speaking at CSPA Annual Meeting

Dr. Rick Kingston will be speaking at the CSPA Annual Meeting in Ft. Lauderdale, FL.  This year’s Annual Meeting will offer guidance on what new federal environmental legislation will mean for your company.  Dr. Kingston’s presentation is on EPA Adverse Event Reporting: Past, Present and Future. Fore more information about the Annual Meeting, head to the CSPA website.

Adverse Event Reporting Webinar

Title: The Importance of a Robust Adverse Event Reporting System Date: Wednesday, October 29, 2014 Time: 2:00 PM Eastern / 11:00 AM Pacific Register here The What, When, Why and How of Serious Adverse Event Reporting Serious Adverse Event Reports (SAERs) should be a major concern for dietary supplement companies as adverse events can happen at any time. SAER issues …

Webinar: The Buzz on Caffeine

Dr. Kingston will join a group of faculty to present a two hour webinar hosted by the Institute of Food Technologists.  More information on the webinar can be found here: http://www.ift.org/knowledge-center/learn-online/live-webcasts/the-buzz-on-caffeine.aspx “The Buzz on Caffeine: New Developments in Safety, Regulation and Adverse Event Reporting” Caffeine, a methylated xanthine, is the most widely used mild central nervous system stimulant, naturally present …

Adverse Event Reports on the Rise – Is there a Safety Issue?

Does FDA’s expectation of increased serious adverse event reports involving dietary supplements signal a safety issue with these products? In recent months, the U.S. Food and Drug Administration (FDA) has been advising dietary supplement companies to review their SOPs regarding adverse event documentation and reporting of serious adverse events to the FDA. FDA believes that there are good indications that …

Welcome to the SafetyCall Blog!

Today SafetyCall enters the blogosphere with the launch of our blog site. Staying true to SafetyCall’s mission of communicating clear and trusted health, safety, and medical information 24/7, the content of our blogs will reflect just that, information and opinions from health care practitioners with a specialized yet broad area of knowledge. That knowledge relates to a clear understanding of …