New Safety Reporting Requirements for Drugs and Biologics: Dissecting the FDA’s Sept. 29 Final Rule and Draft Guidance : Dec 7, 2010

New Safety Reporting Requirements for Drugs and Biologics: Dissecting the FDA’s Sept. 29 Final Rule and Draft Guidance

Monday,  Dec. 7, 2010

 

In 90 fast-paced minutes, Joan Antokol, Managing Partner at Park Legal, LLC and Dr. John McLane, COO and VP Clinical and Regulatory Affairs with Clinquest Inc., will analyze the final rule and guidance, advise how to manage individual safety events in various settings, and offer compliance tips for sponsors, CROs and investigators. You’ll discover:

  • What you must do differently in terms of drug safety reporting, safety surveillance and monitoring
  • New privacy measures you must put in place to be in compliance
  • How U.S. privacy laws (HIPAA/HITECH/state laws), as well as laws of other countries where your products are under study, affect your new responsibilities
  • How to get baseline incidence rates
  • And much more!

Events that suggest a significant risk to study participants must be reported within 15 days of the sponsor becoming aware of such an occurrence, under the new rule. So, you’ll learn how to set up a systematic surveillance program to track and report such safety data, and how to periodically review and analyze safety databases to ensure proper reporting of adverse events associated with investigational drugs.

Who Will Benefit?
  • Directors
  • Pharmacovigilance specialists
  • Clinical project managers
  • Regulatory affairs associates
  • Clinical trial managers
  • Site managers
  • Clinical coordinators
  • Clinical research associates
  • Clinical operation managers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

 

[Update: The slides Dr. McLane used in the presentation are available for free download.]