The Seventh Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference “Solutions to Regulatory Challenges”

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

The Food and Drug Administration (FDA) is announcing its seventh annual educational conference entitled “Solutions to Regulatory Challenges” cosponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the drug, device, and biologics industries with an opportunity to interact with FDA reviewers and compliance officers from FDA's centers and district offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive question and answer, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues.

Date and Time: The conference will be held on June 2 and 3, 2004, from 7:30 a.m. to 5 p.m.

Location: The conference will be held at The Irvine Marriott, 18000 Von Karman Ave., Irvine, CA.

Contact: Ramlah Moussa, Office of Regulatory Affairs (HFR-PA200), Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4408, FAX: 949-608-4456, or Orange County Regulatory Affairs Discussion Group, Attention to Detail, 5319 University Dr., suite 641, Irvine, CA 92612, 949-387-9046, FAX: 949-387-9047, Web site: http://www.ocra-dg.org . (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.)

Registration and Meeting Information: See OCRA Web site at http://www.ocra-dg.org . Contact Attention to Detail at 949-387-9046.

Before May 20, 2004, registration fees are as follows: $495.00 for members, $545.00 for nonmembers, and $325.00 for FDA/government/full-time students with proper identification. After May 20, 2004, $545.00 for members, $595.00 for nonmembers, and $325.00 for FDA/government/full-time students with proper identification.

The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses.

If you need special accommodations due to a disability, please contact Ramlah Moussa at least 10 days in advance.