Bioresearch Monitoring:
What You Want to Know But Were Afraid to Ask

 

February 5, 2009

 

Don’t miss this opportunity to hear advice directly from FDA and other experts on how to approach pharmaceutical and medical device research from a regulatory standpoint. Topics include:

• Laws and regulations related to clinical studies
• Sponsor-monitors
• Institutional review boards and CROs
• Preparations needed for an FDA inspection will be fully described by a senior FDA investigator.

Jointly sponsored by:

• The University of Georgia College of Pharmacy
• The Medical College of Georgia School of Medicine
• The U.S. Food and Drug Administration

Faculty

• Sonali Gunawardhana, Regulatory Counsel, BIMO Program, Center for Devices and Radiological Health, FDA
• Stan Woollen, Consultant (former FDA BIMO program director)
• Stephanie Hubbard , FDA BIMO Senior Investigator
• Valerie Murray, Quintiles Laboratories Ltd.
  

Accreditation

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical College of Georgia School of Medicine and the University of Georgia College of Pharmacy. The Medical College of Georgia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

The Medical College of Georgia School of Medicine designates this educational activity for a maximum of 6.50 AMA PRA Category 1 Credits ™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.

Registration Information

$125 Early Bird, $150 after January 23, 2009.

Registration fee covers all materials, continental breakfast and lunch.

SPECIAL OFFER: For every two paid registrations, get the third registration FREE!

Register online at www.rxugace.com

Location

All sessions will be held on the University of Georgia – Gwinnett Campus, 2530 Sever Rd, Lawrenceville, GA.

For additional information, contact:

Regulatory Affairs Graduate Education Program

Division of Outreach and Nontraditional Education

2530 Sever Road

Lawrenceville, GA 30043-4005

Phone: 678-985-6810