Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER) Small Business Assistance Program

Generic Drug User Fee Amendment (GDUFA) and You Conference

June 12-13, 2013
 

WELCOME TO OUR FIRST GDUFA AND YOU CONFERENCE

This is a MUST ATTEND conference for anyone involved with generic drugs.
The Generic Drug User Fee Amendments of 2012 (GDUFA) is landmark drug legislation designed to speed the delivery of safe, high-quality, and affordable generic drugs to the public and reduce costs to industry.
 
We invite you to attend a conference dedicated entirely to GDUFA. This is your opportunity to interact with FDA subject matter experts as we discuss various regulatory elements of GDUFA.
 

Highlights of Day 1: Comprehensive overviews on:

  • GDUFA
  • User Fees and Arrears List
  • Drug Master Files (DMFs)
  • Compliance Notes
  • DUN and Bradstreet’s (D&B’s) Data Universal Numbering System (DUNS) Number
  • Facility Establishment Identifiers (FEIs)

Highlights of Day 2: Explore in detail the technical aspects of:

  • Electronic Submissions Gateway (ESG) and WebTrader
  • Electronic Self-Identification
  • Self-Identification/eSubmitter

View the Agenda for more detailed information.

 
WHEN:     June 12 – 13, 2013
WHERE:  The Sheraton Silver Spring Hotel    
**NOTE ROOM BLOCK CUT OFF IS JUNE 7 
Contracted rate and room availability cannot be guaranteed after June 7
                 8777 Georgia Avenue
                 Silver Spring, MD 20910
                 Phone: 301-589-0800
                 Toll Free: 1-888-627-7176
                 Reservations
 

CONFERENCE INFORMATION:
  • Advance registration is required.
  • Registration is FREE and includes printed agenda.  Presentation slides will be posted on FDA website approximately 2 weeks after conference ends.
  • Complimentary WiFi/Internet will be available in the guest rooms, meeting area and hotel common areas.
  • Session and conference evaluations will be made available via QR codes. Please download your preferred QR code reading application prior to the event.
  • The meeting will NOT be webcast or taped.
  • CONFERENCE REGISTRATION CLOSES ON JUNE 10.

*The attendee is responsible for accommodations, meals and hotel parking.

NETWORKING:
  • June 12 and 13: Optional lunch networking session Persimmon Room, which is purchase on own.
  • June 12 : Optional networking event in the Mica Lounge from 5pm-8pm which is purchase on own.
Note: Venue is accessible to persons with disabilities. If you have any special accommodation needs, please make requests as soon as possible to Debbie Levi at debbie@tepgevents.com.
 
Questions:    Please contact CDER Small Business Assistance at 1-866-405-5367