Overview
In order to stay on the market, vaping and other electronic nicotine delivery system (ENDS) product manufacturers must submit a PMTA by Wednesday, September 9. Panelists will provide multiple perspectives on the PMTA process, including whether it is an appropriate safeguard of public health or creates a barrier to entry that stifles competition. Panelists will also discuss FDA’s pending review of these applications, including how it may use its enforcement discretion after September 9, how it will apply the public health standard in light of youth and population-wide risks, and what is needed to make the process appropriately efficient and transparent.
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Speakers
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Moira Gilchrist, Vice President, Scientific and Public Communications, Phillip Morris International
Matt Holman, Director, Office of Science, Center for Tobacco Products, FDA
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
STACY L. EHRLICH is a partner at the law firm of Kleinfeld, Kaplan & Becker, LLP in Washington, DC. In her 20th year with the firm, Ms. Ehrlich’s practice focuses on counseling and advocating on behalf of pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of matters involving FDA, USDA, and FTC, as well as state agencies. Ms. Ehrlich is currently outside counsel for the Coalition of Independent Tobacco Manufacturers of America and has been involved in FDA’s regulation of tobacco products since early in the legislative process of the Family Smoking Prevention and Tobacco Control Act. 
STACEY GAGOSIAN has worked in politics and policy for more than 20 years. Currently, she is the Managing Director of Public Policy at Truth Initiative, an organization dedicated to making tobacco a thing of the past. In that position she develops and promotes policies to prevent youth from using tobacco and to help tobacco users quit. She has held progressively responsible roles at Truth Initiative since 2008. As part of her work she has published three articles focusing on flavored tobacco products. From 2003 until 2008, she was the Legislative Associate at the National Breast Cancer Coalition, successfully working to secure research funding and passing legislation requiring more research into the environmental causes of breast cancer. Previously, Ms. Gagosian worked on Capitol Hill in the US House of Representatives and the US Senate. Other positions include a Fundraising Manager for a Senate campaign, and Outreach Coordinator at the Close Up Foundation. Ms. Gagosian has a Bachelor of Arts degree from Kalamazoo College.
MOIRA GILCHRIST was appointed Vice President Strategic & Scientific Communications in January 2018 and is responsible for leading PMI’s strategic communications globally. She was PMI’s lead presenter at the US FDA’s Scientific Advisory Committee meeting on the Modified Risk Tobacco Product Application for IQOS, our heated tobacco product. In her prior role as Vice President Reduced-Risk Products Corporate Affairs, Dr. Gilchrist represented PMI at multiple public conferences and regulatory meetings. Before this she was based in our R&D function where she was Director of Scientific Engagement from 2014 to 2016. Dr. Gilchrist joined PMI in 2006, to work on our Reduced-Risk Product program and held roles in Research and Development as well as Commercialization. Prior to joining PMI, Dr. Gilchrist worked in the pharmaceutical sector for more than 10 years. She was a Principal Consultant in PwC and IBM’s pharmaceutical industry consulting groups, and prior to that, held positions in both the industry and charity sectors, developing new drug formulations. Dr. Gilchrist holds a degree in Pharmacy and a PhD. in Pharmaceutical Sciences, both from the University of Strathclyde in Glasgow, Scotland.
MATTHEW HOLMAN became Director of the Office of Science (OS) at FDA’s Center for Tobacco Products in January 2017. OS is responsible for identifying, developing, and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality. They provide scientific support for regulations and guidance, review tobacco product applications, and carry out research to fill the gaps in scientific knowledge related to tobacco product regulation. Before his current position, Dr. Holman served as Director of the Division of Product Science within OS for six years. In this position, he served as Technical Project Lead (TPL) for over a thousand SE Reports. Before his tenure at CTP, he served as Deputy Director of the Division of Nonprescription Regulation Development in FDA’s Center for Drug Evaluation and Research and earned his PhD in Biochemistry from the University of Maryland at College Park.Virtual Learning FAQ
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