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Monday, June 20 • 4:00pm - 5:00pm
#134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-527-L04-P ; CME 1.00; RN 1.00

PDUFA VII continues and strengthens prior commitments, accelerates CBER’s IT modernization to keep pace with complex scientific advancements, supports the increasing use of digital health technologies in clinical trials, and explores innovation through the use of cloud-based technologies. This session will review the commitments and their value to stakeholders. Join the DIA Regulatory Affairs Community for a follow up round table discussion (session #236 RT) on Tuesday, June 21, 12:30pm - 1:30pm.

Learning Objectives

Describe the data and technology-focused commitments in PDUFA VII.

Chair

Ethan Chen, MBA

Speaker

Moderator
Brooke Casselberry, MS, RAC

IT/Informatics: What's Coming in PDUFA VII
Mary Ann Slack

FDA Update
Michael Foecking


Speakers
MF

Michael Foecking

IT Branch Chief and ADCIO, CBER, FDA, United States
Michael has been in the IT industry for over 38 years. He worked for a variety of software, hardware and services companies before joining the U.S. Federal government 20 years ago. Michael led multiple agency-wide programs across the Department of Health and Human Services. He is... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session