OK. A more serious post. Just received word of a teleconference designed to help with FDA and OHRP compliance in clinical trials. Pasted below are salient points about the audioconference.....
Its sponsors claim that the proram will help attendees better understand the following:
· The key rules and requirements of the FDA and the HHS' OHRP
· What the FDA considers a reportable event and how it is often
misinterpreted
· How to recognize a serious adverse event and then comply with the
different rules governing it
· How to clarify responsibilities so no reporting slips through the cracks
· Best practices for IRBs in managing adverse event compliance
· The most common reporting errors and how to avoid them
· Consequences of not meeting your reporting obligations
· The risks of under-reporting and over-reporting
· How to more effectively manage the scope and severity of adverse events
in pre-market safety reporting
· How to ensure patient safety and avoid the penalties of noncompliance
It has been designed specifically for :
· Research and site coordinators
· Institutional review board (IRB) members
· Study coordinators and monitors
· Investigators
· Principal investigators
· Contract research organization
· Medical staff
And it is taught by lawyer Mark Barnes, who has served as a member of the HHS Secretary's Advisory
Committee for Human Research Protections and is a partner at the law firm
Ropes & Gray. In 2004-2005, Mark was seconded from Ropes & Gray to Harvard
University to serve as the interim executive director overseeing the start
up of Harvard's AIDS treatment programs in Nigeria and Tanzania.
Click for more info:
http://www.fdanews.com/wbi/conferences/aecompliance-espicom.html
A joint Espicom/FDAnews promotion
