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June Biomed/BioTech SIG Meeting  

Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

Jun 11, 2009    6:00 pm - 9:15 pm

�Medication Errors 101!�

Presented by
Linda Y. Kim-Jung, PharmD
Consumer Safety Officer
Medical Review and Pharmacovigilance Team, Division of Surveillance
Office of Surveillance and Compliance
Center for Veterinary Medicine, FDA


�Steps to a Quality CBER Submission�

Presented by
Ms. Susan Yu
Lead Regulatory Quality Manager
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Review (CBER), FDA

Thursday, June 11, 2009

The Kelly�s Deli Conference Room
7519 Standish Place, Rockville, MD 20855

6:00 - 6:15 pm: Networking with a light pizza dinner
6:15 - 9:00 pm: Program
9:00 - 9:15 pm: Door prize drawing and networking

Costs: Free to the general public with a door prize drawing

Registration: To register for this meeting, please click here by Thursday noon, June 11, 2009.

Event Contact: Dr. George Chang at or 240-793-8425.
Program Summary:
Medication Errors 101.  This presentation will include a general introduction about the sources of drug risks followed by a summary of the current medication error prevention initiatives in FDA. The focus of the talk will be in regards to the trade-name confusion and error-prone label/labeling issues.  Lastly, about how medication error prevention and analysis ties into the overall efforts of promoting drug safety will be discussed.

Steps to a Quality CBER Submission. The speaker will provide an overview of the steps to consider when preparing a submission for CBER from a facility and current good manufacturing practice reviewer�s viewpoint. The speaker will provide an overview of the CBER review process and products; identify resources that can be used when preparing a submission; discuss statutes and regulations that must be followed; review steps that may be used to help an efficient CBER review and inspection; review submission pitfalls; and provide comments from reviewers about problems encountered in submissions and during inspection.

For more information and directions to the meeting, see the June 11, 2009 Biomed/Biotech SIG Meeting Announcement.