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  1. News & Events for Human Drugs

Antibody Mediated Rejection in Kidney Transplantation; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. This public workshop is intended to provide information for and gain perspective from individuals, industry, health care professionals, researchers, public health organizations, patients, patient care providers, and other interested persons on various aspects of clinical development of medical products for prophylaxis and/or treatment of AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will also help in developing topics for future discussion.

Dates and Times:

April 12, 2017, from 8 a.m. to 6 p.m. Eastern Time and April 13, 2017, from 8:30 a.m. to 1:30 p.m. Eastern Time

Location:

Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.

The workshop will take place in Ballroom AB, located on the 2nd floor

Registration:

Registration is free. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) by April 6, 2017 to AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov. Registrants will receive email confirmation when they have been registered. Persons without access to the Internet can call 301-796-1300 to register. Onsite registration on the day of the meeting will be provided based on space availability.

Requests for Oral Presentations:

During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make oral presentations must be received no later than April 6, 2017. FDA will review all requests and will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin. Participants will be notified of their selection on or before April 7, 2017. If selected for presentation, any presentation materials must be emailed to AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov no later than April 10, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Contact:

If further information is needed, please contact Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.

Meeting Materials:

The agenda, speaker slides and other meeting material will be posted and/or updated here prior to the workshop. Please note that only printed copies of the agenda, affiliations and disclosures will be provided during the meeting. Please print/bring your own slides, as these will not be provided on the day of the meeting as printed copies.

Meeting Call-In:

In order to listen to the workshop remotely and follow along with the slides being presented, please use the following information below:

To join this meeting

1. Go to https://fda.webex.com/fda/j.php?MTID=m3ce357a7e7eab2b88e8e53e85f325236

2. If requested, enter your name and email address.

3. If a password is required, enter the meeting password: 123456

4. Click "Join".

5. Follow the instructions that appear on your screen.

Teleconference information

1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:

Local: 1-301-796-7777

toll free: 1-855-828-1770

2. Follow the instructions that you hear on the phone.

Your Cisco Unified Meeting Place meeting ID: 741 295 076

Please test your WebEx capability prior to the start of the workshop. Please also remember to mute your phones during the meeting.

Transcripts: