6 March 2019
12:00 – 1:30 PM
Registration
Information
Webcast registration includes access to handouts, presentation slides
and the on-demand recording for one year.
RAPS Members: $0
Nonmembers: $0
Description
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.
Learning Objectives
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 in
regulatory affairs
Speakers
Bethany Hills, 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.
Joanne Hawana, 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.
Benjamin Zegarelli, 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.