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CDER Town Hall (Part 2 of 2)

Track:
Global Regulatory

Day & Time:
June 19, 10:45AM - 12:15PM (Pacific Standard Time)

Session Number:
426

Room Number:
6B

Level:
Basic

Type:
Forum

Title:
CDER Town Hall (Part 2 of 2)

Chair(s):
Nancy D. Smith, PhD
Adjunct Professor
Temple University, FDA Alumni, United States

Description:
This forum is a roundtable discussion with CDER leadership. It will include discussion and updates on regulatory changes; hot topics at CDER will be discussed, and the audience will be invited to submit questions of general interest.

Part 2 will take place on Thursday at 9:00 am (Session #414).

Please come prepared with your questions for the CDER Town Hall panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “CDER Town Hall” in the subject line.


Learning Objective(s):
Summarize key issues discussed by CDER; Identify regulatory hot topics.

Presentation(s) & Speaker(s):
Panelist
Gerald J. Dal Pan, MD
Director, Office of Surveillance and Epidemiology, CDER
FDA, United States

Panelist
John K. Jenkins, MD
Director, Office of New Drugs, CDER
FDA, United States

Panelist
Sandra L. Kweder, MD, FACP
Deputy Director, Office of New Drugs, CDER
FDA, United States

Panelist
Justina A. Molzon, JD, MSc, RPh
Associate Director for International Programs, Office of Strategic Program CDER
FDA, United States

Panelist
Christine M. V. Moore, PhD
Acting Director, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States