is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, March 9th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
