SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

2019 Electronic Drug Registration and Listing Using CDER Direct Header Banner

Electronic Drug Registration and Listing
Using CDER Direct
October 22, 2019

This event is FREE to attend

The Hotel at the University of Maryland – College Park, Maryland
or attend Virtually Online

Bring your laptop and submit your annual registration and listing renewals on the spot.

The drug registration and listing staff is hosting a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions.

This year will focus on the top errors and mistakes observed with submissions and highlight FDA’s newly announced process for inactivation of uncertified listings.

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Keynote Speaker:

Paul Loebach
Director
Drug Registration and Listing Staff
Office of Program and Regulatory Operations
CDER | FDA

Paul Loebach

Topics Include:

  • Drug registration and listing compliance program featuring a case study of a violation
  • Registration and labeler code requests
  • NDC reservation, drug listing, and 503B compounder product reporting
  • Listing certification and FDA inactivation of uncertified listings
  • Town Hall with the DRLS staff

Full Agenda

Who Should Attend?

  • Regulatory affairs professionals working on registration and listing or who submit Structured Product Labeling (SPL) to FDA
  • Members of Industry who submit Registration and Listing
  • US Agents for Foreign registrants
  • Importers and import agents
  • Consultants and law firms representing pharmaceutical companies s

Continuing Education Credit

  • This one-day conference has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
  • This event has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
  • SOCRA 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.
  • Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.
Agenda & Speaker Bios

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Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 4, uploaded on October 9, 2019.

PDF Download
Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

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Onsite Attendance Information

VenueImage of the ballroom in The Hotel at UMD

The Hotel at the University of Maryland (thehotelumd.com)
7777 Baltimore Avenue, College Park, Maryland 20740
Phone: 301-277-7777

Conference is in Ballroom A

Hotel Room Block Information

You may reserve your guest room within the 2019 Electronic Drug Registration & Listing Workshop room block using this link or by calling THE HOTEL’s reservations line at 301-277-7777. The discounted rate of $199 will expire on October 14, 2019 or when the block is filled, whichever comes first, so please book your rooms now. You will be responsible to reserve and pay for your own room accommodations. Please be mindful of the hotel’s policy regarding cancellations and early checkout.

Transportation & Parking

Please view the hotel’s Transportation page for transportation and parking information.

Dining

Please view the hotel’s Dining page for information on the food choice in the hotel. Potomac Pizza and Bagel ‘n Grinds allow you to pre-order online, which may help expedite your lunch break.

Networking Opportunity

A networking opportunitis durng the breaks and lunch break are available for on-site attendees during the conference. These are optional self-pay opportunities.

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 [email protected] 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: [email protected]

Virtual Attendance Information

Please register to attend virtually if you are unable to travel to College Park, MD to attend in-person. The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.

Room One will open 15 minutes before the event begins.

Please try Room One first.
Room Two will only be activated if Room One exceeds 1,000 participants.
Please do not join both rooms at the same time.

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, Certificate & Recordings

ZIP of the Workshop Slides

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

The links to the recordings (below) will become active within 24 hours after each session concludes.

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Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at [email protected].

More Information

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