FDA Final Rule on Safety Information During Clinical Trials

The U.S. Food and Drug Administration issued a final rule on September 28, 2010 that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. This webinar will discuss the operational changes you will need to implement to support the new rule.
 
Topics to be covered:

•     The need for pharmaceutical and biotech companies to manage accumulating safety data from the clinical database
•     Additionally defined sources of safety information
•     New ways of reporting safety events from endpoint studies and from a worsening of the  underlying disease
•     The need for more unblinded data review
•     Analysis of similar events & causality assessment of SUSARs
•     Bioavailability & Bioequivalence requirements

Expert Panelists:
 
Anthony Faragasso, MD, MPH
Senior Director, Drug Safety and Risk Management
ICON Clinical Research
 
Mirza Rahman, MD, MPH
Senior Director,
Clinical Risk Management
Merck & Co., Inc.

Irina Baeumer, MD, PhD
Sr. Director Medical & Safety Services
ICON Clinical Research

Click here to view speaker profiles
 
Moderator:
Peter Schueler M.D.,
Sr. Vice President,
Global Medical & Safety Services,
ICON Clinical Research