Events

Bethesda Marriott Pooks Hill

Bethesda, MD

June 1 - 2, 2011

Agenda | Sponsorship | Tip Sheet

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 during a full 1 day workshop. Also as a bonus you will be able to hear the latest directly from the Division of Drug Marketing, Advertising and Communications (DDMAC) during a half day workshop which will focus on drug advertising issues that are specific to the generic industry.

This workshop is designed to provide industry with current information on the ANDA labeling review process as well as the many issues facing the generic industry when submitting ANDA labels

Key Workshop Issues Include:
•Recommendations for industry on handling last-minute labeling “carve-outs”
• Update on the advisory and enforcement processes for DDMAC and generic drug activity
• The impact of REMS on the ANDA labeling review process
• MedGuide Requirements
• Risk management plan challenges
• Pediatric exclusivity considerations
• Best practices for ANDA labeling
• Best practices for DDMAC

Registration Fees:
ANDA Labeling and DDMAC Workshop Registration
Government - $300.00
GPhA Member - $1,050.00
Non Members - $1,400.00

ANDA Labeling Workshop Registration ONLY
Government - $250.00
GPhA Member - $850.00
Nonmember - $1,050.00

DDMAC Workshop Registration ONLY
Government - $120.00
GPhA Member - $400.00
Nonmember - $550.00

Cancellations:
Cancellations must be received in writing emailed to jnguyen@gphaonline.org by May 18, and confirmed by GPhA. All cancellations are subject to a $200 processing fee. No refunds after May 18, 2011.

Hotel Information:
Bethesda Marriott
5151 Pooks Hill Road
Bethesda, Maryland 20814
To reserve a hotel room, call 800-228-9290

Sponsorship
GPhA is offering sponsorship opportunities that include significant exposure to the workshop attendees throughout the program. For more information, contact Katie Dysart, kdysart@gphaonline.org.

Registration
Please contact Jennifer Nguyen for registration questions (jnguyen@gphaonline.org or 202-249-7127).

ANDA Labeling/DDMAC Workshop Sonsorship:

Publication Partners: