BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T182244Z UID:3287fbcb-0221-4e1d-8bfd-b50a338ef6c2 DTSTART:20211012T090000 DTEND:20211013T090000 CLASS:PRIVATE DESCRIPTION:
If you go "\;off label"\; with advertising and promo tion\, FDA'\;s hammer can hit hard and seemingly out of the blue. Adver tising and promotion for devices is weak and lacks legal clarity. For drug s\, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock\, however is that mar keting managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
\n\nFDA'\;s Cent er for Devices and Radiological Health (CDRH) has never issued a comprehen sive guidance on advertising and promotion. You are on your own. In contra st\, FDA'\;s Center for Drug Evaluation and Research (CDER) uses long-s tanding regulations and a growing number of guidance documents in its regu latory approach. Policing social media has become a new regulatory respons ibility and FDA is still trying to figure out how to deal with it. Bottom line\, do you know when you fail to meet FDA'\;s requirements or are yo u guessing? Can you afford to guess? The cost to your business and the con fusion left in your customers'\; mind becomes an unwelcomed nightmare.< /p>\n\n
In this seminar\, you will learn how to navigate FDA'\;s nume rous legal options and how to interpret them based on basic legal principl es. Applying new guidance documents becomes a new test of the FDA'\;s l egal boundaries and enforcement options. The agency is now conducting clin ical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipli ne may or may not get to the root of what consumers take away as the messa ge.
\n\nCongress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidenc e for safety and effectiveness is evaluated by the FDA. Valid off-label in formation may take the lead in that direction.
\n\nThis conference w ill provide insight on how to manage your marketing activity and gauge wha t regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing\, regulatory a ffairs\, legal counsel\, manufacturing\, engineering and finance departmen ts. Operating in a stovepipe environment will not work. You need to unders tand that a weak link in any department leaves the entire corporation vuln erable to FDA enforcement. Most importantly\, you will understand the boun daries that FDA uses and how easy it is to cross them. With information fr om this course\, you can step back and rationally evaluate your firm'\; s regulatory profile for advertising and promotion practices.
\n\nFDA regulates advertising and promotion material
as labeling. The legal definition of labeling covers just about anything t
hat explicitly or implicitly conveys a message intended to affect a person
'\;s behavior and decision outcomes. The vehicle for communication has
evolved dramatically over the past 100 years and continues to evolve at a
rate faster than one can anticipate at times. How FDA applies its legal te
nants of false and misleading information or variations on that theme requ
ires continual updating by FDA and constant re-evaluation by industry. Now
the legal field playing field involves other federal agencies and departm
ents\, and they work in concert with FDA. It has become very complicated a
nd very costly if you knowingly or unknowing walk into a legal snare. This
seminar is designed to bring you up to speed so you are clearer about wha
t is a problem\, what is not a problem and what becomes a risk laden judgm
ent call.
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\n \;
8:30 AM - 9:00 AM: \;Registration
\n\n9:00 AM - 10:30 AM
\n\nLecture 1: \;FDA legal authority
\n\n10:30 AM - 12:00 PM
\n\nLecture 2: \;Promotion and Advertising: scope of labeling
\n\n1:00 PM - 2:30 PM
\n\nLecture 3: \;< strong>Supreme Court / commercial free speech
\n\n2:30 PM - 2:45 PM \;Break
\n\n2:45 PM - 4:30 PM
\n\nLecture 1: \;
\nDirect to
consumer advertising vectors \;
\nFederal Trade Commission intere
st (economic vs. safety) \;
\nContext and format of messaging&nbs
p\;
\nScript versus message
10:30 AM - 12:00 PM
\n\nLecture 2: \;False and m isleading information
\n\n1:00 PM - 2:30 PM
\n\nLecture 3: \;
\nOff label use - practi
ces and policy
\nFDA Warning Letters
2:30 PM - 2:45 PM \;Break
\n\n2:45 PM - 4:30 PM
\n\ nLecture 4: \;
\nPractice of medicine exemption
\
nCustom Device promotion \;
\n(Group Hypothetical) \;
\n
Corporate management responsibility
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\n \;
Casper (Cap) Uldriks \;
owns Encore Insight LLC\, which provides consulting services on FDA Law. H
e brings over 32 years of experience from the FDA. He specialized in the F
DA'\;s medical device program as a field investigator\, served as a sen
ior manager in the Office of Compliance and as an Associate Center Directo
r for the Center for Devices and Radiological Health. He developed enforce
ment actions and participated in the implementation of new statutory requi
rements. He is recognized as an exceptional and energetic speaker. His com
ments are candid\, straightforward and of practical value. He understands
how FDA thinks\, operates and where it is headed.
\n
\nPlease co
ntact Marilyn Turner: Phone: +1 929 900 1853  \;Email: marilyn.turner
[a] nyeventslist.com for registrations