Events

Bethesda North Marriott Hotel and Conference Center

North Bethesda, MD

April 14 - 15, 2010

Overview | Sponsorship Form | Agenda

Don’t miss this unique opportunity to hear directly from FDA’s
Office of Generic Drugs (OGD) Labeling Review Staff responsible for reviewing and approving your applications.

GPhA is pleased to announce the GPhA ANDA Labeling Workshop.
This workshop is designed to provide industry with current information on the ANDA labeling review process as well as the many issues now facing the generic industry when submitting ANDA labeling.

Key Workshop Issues Include:

• Recommendations for industry on handling last-minute labeling “carve-outs”
• Updates on SPL formatting
• The impact of REMS on the ANDA labeling review process
• MedGuide Requirements
• Risk management plan challenges
• Pediatric exclusivity considerations
• Best practices for ANDA labeling

Hotel Information:

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Reservations must be made directly with the hotel by calling 800-228-9290. Please refer to “GPhA ANDA Labeling Workshop” to obtain the preferred rate. There are a limited number of rooms available at the preferred rate. The cut-off date for this rate is Tuesday, March 23, 2010. After this date or once the rooms are sold out, reservations are subject to standard hotel rates and availability.

Fees:

GPhA Member Full Conference: $1050

Nonmember Full Conference: $1400

Separate registration for each of the two days is available. Contact GPhA for details.

Cancellations:

Cancellations must be received in writing either faxed to 703-647-2481 or emailed to jnguyen@gphaonline.org by April 7, and confirmed by GPhA. All cancellations are subject to a $200 processing fee. No refunds after April 7, 2010.