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FDA Generic Drugs Forum 2024

Generic Drugs Forum (GDF) 2024:
Regulatory Considerations to Enhance Generic Drug Access
April 10-11, 2024

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This is a NO COST event

The Bethesdan Hotel – Bethesda, Maryland
or attend Virtually Online

The Generic Drugs Forum is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

Click Here for Workshop Details

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Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is still being refined and may be updated over time. The current version is v1, uploaded on February 27, 2024.

PDF Download
Speaker Biographies

The speaker biographies document is under development and will be linked here when it is ready.

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Onsite Attendance Information

VenueImage of the ballroom in The Hotel at UMD

The Bethesdan Hotel
8120 Wisconsin Avenue, Bethesda, MD 20814
Phone: 301-652-2000

BOOK YOUR ROOM

Hotel Information

You may reserve your guest room by calling the hotel directly at (301) 652-2000 and ask to be added to the “Generic Drugs Forum” room block, or use this link to reserve online. The room block will close on March 29, 2024, or when the block is full, so don’t delay, reserve your room now! You will be responsible for reserving and paying for your own room accommodation. Please be mindful of the hotel’s policy regarding cancellations and early checkout. Check-in: 3:00 p.m. Checkout: 12:00 p.m.

Transportation & Parking

  • Onsite Hotel discounted attendee parking: $10.00/day (regular $27.00); $15.00 discounted overnight parking
  • Other paid parking garages nearby:
    • Colonial Parking Garage (459 ft. from hotel): 8200 Wisconsin Avenue, Bethesda, MD 20814
    • Garage 35 – Woodmont (0.1 miles from hotel): 7730 Woodmont Avenue, Bethesda, MD 20814 – Entrances: Woodmont Ave. & Old Georgetown Rd.
    • Garage 40 – Cordell-St. Elmo (0.3 miles from hotel): 4935 St. Elmo Avenue, Bethesda, MD 20814 – Entrances: St. Elmo Avenue and Cordell Avenue
  • Medical Center metro station – the hotel is 1 mile from Walter Reed National Military Medical Center
  • Complimentary hotel shuttle to Metro is available

Dining

Please view the hotel’s Dining page for information on the food choice in the hotel.

Networking Opportunity

A networking opportunity is available for on-site attendees during the conference. The networking event will be held in the Fialova Bar at the hotel. This is an optional self-pay event.

Recording Disclosure

This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.

For Reasonable Accommodations

If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.

Virtual Attendance: LOGIN Information

The links below will become active on the day of the workshop.

Room One

Ability to submit questions, but cannot pause or rewind
1,000 seatsUse Room Two if this room is full

Room Two

Ability to submit questions, Ability to pause or rewind
Unlimited Seating

The above rooms will open ~15 minutes before each day begins.

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files & Recordings

Download Presentation Slides:

ZIP of the Day One Slides

ZIP of the Day Two Slides

The links above will become active on the day before the event begins.

Evaluation & Certificate:

Evaluation & Certificate of Attendance

The above link will become active near the close of the first day of the event.

Session Recordings:


Recordings will be linked here as soon as they are available.

Questions & More Information

Continuing Education:

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.

Certificates are only available during the two weeks post-event (until April 25, 2024).

This event has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: