Wednesday, 6 March 2019
12:00 – 1:30 PM EST
Product promotion is crucial for driving the business of a drug, biologic or medical device manufacturer, but the content of medical product advertising and promotional labeling are subject to the regulatory oversight of FDA and, in some cases FTC. While FDA’s regulations directly related to promotional labeling and advertising are limited, both FDA and FTC have issued numerous lengthy guidance, policy and enforcement documents that create a complex legal landscape with many gray areas. The speakers recently authored a book published by RAPS, Promotion of FDA-Regulated Medical Products, which explains promotional labeling requirements and provides regulatory compliance advice. This webcast will provide an overview of the book content and will go beyond to discuss considerations for implementing quality systems and procedures that will help you remain in compliance with promotional labeling regulations. You will learn about FDA’s and FTC’s respective responsibilities for enforcement of medical product promotion; the similarities and major distinctions among promotional labeling requirements for drugs, biologics and devices; and the critical policies and procedures necessary to ensure promotional labeling complies with applicable regulations and guidance.Learning Levels:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
- Identify the regulatory standards that apply to each medical product type
- Understand the major issues that are the focus of FDA and FTC scrutiny of medical product promotions
- Understand the basic elements necessary to implement a regulatory process to help ensure promotional activities comply with FDA and FTC regulations and guidance
Who Should Attend?
- executives who oversee regulatory affairs
- regulatory affairs managers and personnel
- in-house attorneys who are involved with regulatory affairs
, chair FDA practice, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.
Bethany Hills is chair of the Mintz FDA practice. She is nationally recognized for her experience and insight on FDA matters and advises businesses on both pre- and postmarketing issues, including everything from FDA submissions and communications to post approval compliance. She also helps international and US companies enter and navigate the US healthcare market. Hills holds an MPH and JD from the State University of New York–Buffalo.
, member, Mintz, Levin, Cohn, Ferris, Glovsy & Popeo, P.C.
Joanne Hawana is a member of the Mintz FDA practice team. She counsels global clients on regulatory and distribution-related considerations for bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. Hawana also advises on the business impact of new US federal and state actions that affect those regulated products. She holds an MS in molecular genetics and microbiology from the University of Medicine and Dentistry of New Jersey and a JD from the University of Maryland School of Law.
, associate, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.
Benjamin Zegarelli is a member of the Mintz FDA practice team. He provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Zegarelli advises a broad range of healthcare and life science industry clients on the federal and state laws surrounding medical product development, manufacturing and marketing. He holds an MS in organic chemistry from the California Institute of Technology and a JD from the Benjamin N. Cardozo School of Law.
Registration Information Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.