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Monday, June 17 • 11:00am - 12:00pm
#110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-524-L04-P; CME 1.00; RN 1.00

In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.

Learning Objectives

Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of the NDRP workstreams.

Chair

Yoni Tyberg, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Meghana Chalasani, MHA

Panelist
Michael Monteleone, MS, RAC

Panelist
Andrew Emmett, MPH


Speakers
avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Advisory Committees, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
avatar for Andrew Emmett

Andrew Emmett

FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States
Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →
MM

Michael Monteleone

Associate Director for Labeling, OND, CDER, FDA, United States
Mr. Michael Monteleone is currently an Associate Director for Labeling in the Office of New Drugs at CDER, FDA. Michael has also held positions in Regulatory Affairs and Project Management throughout his 15 year tenure at the FDA.
YT

Yoni Tyberg

Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States
Yoni Tyberg is the Associate Director of Special Program Staff (SPS) at the Office of New Drugs within CDER. In this role, Yoni supports the strategic planning, project development and execution of the New Drug Regulatory Program Modernization efforts across OND and CDER. He had also... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum