SBIA Education Events

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

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FDA REdI Annual Conference 2019
May 29-30, 2019

This event is FREE to attend

REVERE HOTEL | Boston Common – Boston, Massachusetts
or attend Virtually Online

In-Person registration is now closed as we have exceeded capacity.
You can still register to attend Virtually.

Image of the downtown Boston skylineThe Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) invite you to interact with and learn directly from FDA’s regulatory experts. This conference is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements.

Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA.

FDA speakers will be available to answer questions one-on-one at the end of each day.

REGISTER NOW

Topics Include:

  • Keynote Speaker: Doug Throckmorton, MD | Deputy Director for Regulatory Affairs | CDER | FDA
  • Keynote Speaker: William H. Maisel, MD, MPH | Director, Office of Device Evaluation | CDRH | FDA
  • Keynote Speaker: Joseph Matrisciano Jr. | Program Division Director | Office of Regulatory Affairs | FDA
  • Plenary Session: Navigating the World of Combination Products
  • A Medical Officer’s Approach to NDA/BLA Review
  • Regulatory Highlights for Biosimilars and Interchangeables
  • Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements
  • Building Quality Clinical Data into Premarket Approval Applications (PMAs)

View Full Agenda

Who Should Attend?

Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission as well as globalization, harmonization, and standardization of medical device regulation.

  • Newcomers, managers, or directors in the drug or medical device industries
  • Regulatory affairs
  • Research and development
  • Quality assurance and control
  • Development and preparation of submissions

Continuing Education Credit

  • This two-day conference has been pre-approved by RAPS as eligible for up to 12 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 continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 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.
  • Attendance is required for attendance certificates which are only available during the two weeks after the event.
Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is: Version 7, published on May 21, 2019.

PDF Download
Speaker Biographies

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

Onsite Attendance Information

Sorry, but In-Person registration is now closed as we have exceeded capacity.
You can still register to attend Virtually.

VenueImage of the downtown Boston skyline

REVERE HOTEL | Boston Common (reverehotel.com)
200 Stuart Street, Boston, Massachusetts 02116
Phone: 617-482-1800

Conference is in the Grand Master Ballroom

Hotel Room Block Information

Our room block is now full. Please check room availability or book directly with the hotel at Reverehotel.com. You will be responsible to reserve and pay for your own accommodation.

Transportation & Parking

From/To Boston Logan Airport: hotel is located approximately 3 miles from the airport:

  • Approximate costs: Taxi – $25.00; Lyft or Uber: $10 each way
  • GoBoston Shuttle: Gobostonloganairport.com or reserve via hotel concierge

Boston Subway T: Hotel is within walking distance to public transportation – Arlington St. & Boylston St. “T” (Green Line). South Station (Red Line) is approximately a 10-minute walk.

Parking: Attached covered parking garage offers self-parking at $42.00/day, or valet parking at $54.00/day.

Networking Opportunity

A networking opportunity is available for on-site attendees during the conference. The networking event will be held in the [email protected] at REVERE HOTEL | Boston Common. 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.

Virtual Attendance Information

Please register to attend virtually if you are unable to travel to Boston, MA to attend in-person. The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 in each the CDER and the CDRH track). If the room is full when you attempt to enter, you can try back again later. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.

The links below to the Adobe Connect room for each track will be activated shortly before the event begins.

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

You can switch between the two rooms as you like, but please do not join both rooms at once. The Keynote and Plenary sessions on Day One will be broadcast in both rooms.

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

The above links will become active ~24 hours before the event begins.

Link to Final Evaluation & Certificate of Attendance

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

General Session Recordings:

  • Keynote: Office of Regulatory Affairs (ORA) Update – Joseph Matrisciano Jr.
    Recording Coming Soon
  • Plenary: Navigating the World of Combination Products – James Bertram & Kristina Lauritsen
    Recording Coming Soon

Session Recordings: CDER (Drugs) Track

Day One:

Day Two:

Session Recordings: CDRH (Devices) Track

Day One:

Day Two:

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: