Overview
This webinar will provide strategies to meaningfully establish two-way engagement between FDA and industry. These channels include both formal meeting opportunities and communication between regulatory professionals in informal settings—ombudsman programs, advisory committees, patient engagement listening sessions, and more. Panelists will use practical examples to illustrate how to effectively engage with FDA and address issues in different FDA-regulated product areas using these available channels, as well as appealing agency decisions.
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Speakers
Meghana Chalasani, Team Lead for the Advisory Committee Team, Office of New Drugs, FDA
Erica M. Katherine, Ombudsman, Office of Regulatory Affairs, FDA
Jen Mercier, Office Director for the Office of Regulatory Operations, Office of New Drugs
Jessica L. Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Life Sciences
Moderated by Lowell M. Zeta, Partner, Hogan Lovells US LLP
MEGHANA CHALASANI leads the Advisory Committee Team and the Science Strategies program in FDA Center for Drug Evaluation and Research’s (CDER) Office of New Drugs. She also co-leads the New Drugs Regulatory Program’s Advisory Committee workstream, a modernization effort to enhance CDER’s advisory committees. Previously, Meghana worked closely on CDER’s Patient-Focused Drug Development Program, Rare Disease Cures Accelerator, and Benefit-Risk Framework. Meghana holds a master’s degree in health policy and management from Columbia University and a bachelor’s degree in medicine, health, and society from Vanderbilt University.
ERICA M. KATHERINE is the ombudsman for the FDA Office of Regulatory Affairs (ORA) and has held this position since 2019. As the ORA ombudsman, she informally assists in the resolution of individual and systemic process issues by helping stakeholders to identify and evaluate options; explaining the appropriate process for resolution; and monitoring the outcome of the issue to ensure transparency and fairness. Ms. Katherine began her career at FDA in 2008 as an investigator, later transitioning to the role of compliance officer where she gained experience in the domestic and import programs. Ms. Katherine also serves on the Coalition of Federal Ombudsman Executive Committee and is a voting member of the United States Ombudsman Association. She holds a MS in Biotechnology – Regulatory Affairs from the University of Maryland University College, and a BS in Chemistry from Jackson State University.
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 regulatory review activities. Jennifer has 27 years of regulatory project management experience, mostly in the Division of Urology, Obstetrics and Gynecology. Jennifer served as one of the leads on the development and implementation of the reorganization of OND and creation of ORO. 
JESSICA L. ZELLER is Vice President, Quality, Regulatory, and Public Affairs Counsel at Edwards Lifesciences based out of Irvine, CA. Jessica routinely counsels on global medical device regulatory compliance matters and quality systems concerns, including interacting with government regulators. She was previously FDA’s inaugural ORA Ombudsman, focusing on problem-solving with respect to FDA’s field offices, including inspections, imports, and other agency processes and procedures. Additionally, Jessica has served as the Deputy Directory of Compliance and Enforcement for FDA’s Center for Tobacco Products, as a litigation attorney in FDA’s Office of Chief Counsel, as the lead FDA lawyer for Procter & Gamble, and is the co-editor on an upcoming FDLI publication about How to Work with the FDA. Jessica holds a JD/MA (Bioethics) from University of Virginia and a BS (Biology) from Xavier University.
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