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Thursday June 18, 2026 9:30am - 10:30am EDT
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-652-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from the U.S. Food and Drug Administration (FDA) will provide an update on key priorities, including the Commissioner's National Priority Voucher Program, artificial intelligence in drug and biological product development, and the Agency's digital transformation efforts. The session will provide the opportunity for the audience to ask questions.

Learning Objectives

Discuss FDA’s key initiatives and strategic priorities; Identify opportunities for engagement with FDA regulators.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
R. Angelo De Claro, MD

Panelist
Katherine Szarama

Panelist
Jeremy Walsh

Panelist
Mallika Mundkur, MD, MPH


Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and is part of the FDA team for Prescription Drug... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
MM

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States
KS

Katherine Szarama

Deputy Director, CBER, FDA, United States
JW

Jeremy Walsh

Chief AI Officer, OC, FDA, United States
Thursday June 18, 2026 9:30am - 10:30am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

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