The Food and Drug Administration's (FDA)
Center for Drug Evaluation and Research (CDER)
 and
Center for Devices and Radiological Health (CDRH)
are pleased to announce a co-sponsored seminar developed just for you:

FDA Small Business Regulatory Education for Industry (REdI) Conference
Fall 2013

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our intended audience is the small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.

 

Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference features a cross-cutting plenary addressing FDASIA updates as they impact both drugs and devices, as well as individual break-out sessions which focus on the unique issues of drugs and devices. Common themes include:

  • Meetings with FDA
  • Clinical Studies and Review
  • Site Inspections
WHEN: September 25 – 26, 2013
WHERE: The Hyatt Regency Bethesda
One Bethesda Metro Center  (7400 Wisconsin Ave)
Bethesda, MD  20814
Phone: 301-657-1234
 
**NOTE HOTEL ROOM BLOCK CUT OFF IS SEPTEMBER 6. 
Group rate and room availability cannot be guaranteed after September 6
PLEASE VISIT THE LOCATION PAGE (located along the top of this page) FOR ADDITIONAL HOTEL INFORMATION
                 
CONFERENCE INFORMATION
  • At the top of this page are the page name tabs for the different pages of this website.  Click on the page name to go to the page you want.
  • Advance registration is required. SELECT THE REGISTRATION TAB AT THE TOP OF THE PAGE TO REGISTER FOR THE CONFERENCE.  
  • For conference registration questions or logistical questions, contact: Debbie Levi, Debbie@tepgevents.com
  • Registration is FREE, but seating is limited. We ask that you honor your registration commitment.  If you are a registered attendee and are unable to attend please contact Debbie Levi, Debbie@tepgevents.com
  • This conference will NOT be webcast or taped. Presentation slides and conference surveys will be provided electronically to participants. URLs will be made available upon conference sign in onsite.
  • WiFi/Internet will be available complimentary in the meeting area and guest rooms. 
  • ONLINE CONFERENCE REGISTRATION CLOSES ON  SEPTEMBER 20 at 5pm. To register after September 20 see Registration page for additional information.

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

NETWORKING:
  • September 25 and 26: Optional networking session during lunch in the Concours Terrace seating area.  You may choose to pre-order and purchase a boxed lunch ($15 inc of tax) at the conference registration table each morning. NOTE boxed lunches are CASH or Room charge ONLY.  Checks, credit or debit cards will not be accepted. 
  • September 25 : Optional self pay networking event in the Concours Terrace seating area from 5-8pm.

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