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Thursday, July 1 • 10:00am - 11:00am
#412 SL: Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-643-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will take a deep dive into FDA’s integrated review for marketing applications from an operations perspective. We will hear about the new review templates and how FDA has changed internal processes, review content, and role responsibilities.

Learning Objectives

Explain the operational and organizational changes FDA made to the New Drugs Regulatory Program to support an integrated review for marketing applications; Name the new processes and templates, and new and changing roles FDA has developed to modernize the review of marketing applications; Summarize what industry can expect through these changes and once a steady state is reached.

Chair

Amy Bertha

Speaker

Integrated Assessment Process: ORO Regulatory Project Management Perspective
Jennifer L Mercier

INMAZEB Case Study: FDA Perspective
John Farley, MD, MPH

Integrated Assessment of Marketing Applications Overview
Rhonda Hearns-Stewart, MD

INMAZEB Case Study: Industry Perspective
Janie Parrino, MD



Speakers
avatar for Amy Bertha

Amy Bertha

Executive Director, Regulatory Policy, Bayer, United States
Amy Bertha is currently Senior Director, Regulatory Policy at Bayer. Prior to joining Bayer in 2018, Amy worked 14 years at the FDA's Center for Drug Evaluation and Research in various offices, including the Regulatory Affairs Team in the Office of New Drugs and the Special Projects... Read More →
JF

John Farley

Director, Office of Infectious Diseases, OND, CDER, FDA, United States
Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation... Read More →
RH

Rhonda Hearns-Stewart

Associate Director, Implementation for the Integrated Assessment of Marketing Ap, FDA, United States
Rhonda Hearns-Stewart, MD, is the Associate Director of Implementation for the New Integrated Assessment of Marketing Applications. She is also on the staff at Walter Reed National Military Medical Center where she sees patients once a week. In 2013, Dr. Hearns joined the FDA as a... Read More →
JM

Jennifer Mercier

Director, Office of Regulatory Operations, OND, CDER, FDA, United States
Jennifer Mercier is the Director of the newly formed Office of Regulatory Operations (ORO) in CDER’s Office of New Drugs (OND). As Director, she is responsible for the oversight of OND’s regulatory review processes and regulatory project management (RPM) staff, who co-lead OND’s... Read More →
JP

Janie Parrino

Executive Director, Regulatory Affairs, Regeneron Pharmaceuticals, Inc, United States
Janie Parrino, MD, is Executive Director of Regulatory Affairs at Regeneron Pharmaceuticals, Inc. Dr. Parrino has 15 years of experience in government and pharmaceutical industry settings in drug and vaccine development. In her regulatory role at Regeneron, Dr. Parrino oversees activities... Read More →


Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session