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*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***\nREGISTER TODAY!
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\n\nLearnin g Objectives:
\n\nKey goals of the conference will include learning:
\n\nThe basics of FDA law and regulations go verning advertising and promotion\, as well as sister agencies such as the Federal Trade Commission\, which shares jurisdiction with FDA on certain regulated products (e.g.\, OTC drugs).
\nThe distinc tions between labels\, labeling and advertising and how that impacts FDA 39\;s powers\, and
\nHow to properly position Direct -to-Consumer (DTC) promotions
\nThe Dos and Don'\ ;ts of promoting products on the internet\, including social media sites s uch as Facebook and Twitter
\nThe perils of off-labe l promotion\, including criminal and civil actions that have led to multi- billion dollar settlements by regulated drug companies
\nWhether the First Amendment provides any insulation for truthful stat ements regarding regulated products\;
\nWhen dissemi nating medical educational materials crosses the line into improper promot ion\; and
\nKey considerations on how to implement a ppropriate procedures and controls in your company to minimize the potenti al for regulatory action by the FDA or the FTC relative to promotion and a dvertising.
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\n\nWho will Be nefit:
\n\nSenior executives\, directors\, managers and tho se who have responsibility for implementing advertising and promotional ac tivities\, as well as those that have key collateral roles in reviewing ad vertising for drug and device firms\, including officials from these areas within regulated companies:
\n\nSales
\nMarketing
\n \nMedical Affairs
\nLegal
\n \nRegulatory
\nCompliance
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\n\nAGENDA
\n\n
\nDay 01(8:30 AM - 4:30 PM)
08.30 AM - 09.00 AM: Registration
\n09.00 AM: Session Start
\nI
. Understanding the Basics
\nWho Has Jurisdiction
\nDrugs &\;
Biologics
\nRx Drug Advertising
\nOTC Drug Advertising
\nD
evices
\nRestricted
\nall other
\nLabeling vs. Advertising<
br />\nBasic drug rules
\nFair balance
\nDevice rules
\nInt
ended use deviations
\nDTC advertising
\nPrint
\nTV
\n
Comparative Claims
\nstandard to support
\npush to pursue CER
\nDetailing and Sampling
\nis there still a future?
\nwhat ca
n be said?
\ndanger of &ldquo\;custom&rdquo\; pieces
\nHow FDA l
earns of violations
\nKeep your house clean or your competitors will
rat you out
\nII. Scientific Exchange
\nGuidances on Disseminati
on of Scientific Information
\nRisks involved in Off-Label Statements
\nProcedural Requirements and Unsolicited Requests for Information\nIII. First Amendment
\nUnderstanding &ldquo\;Commercial Speech&
rdquo\; Doctrine
\nFDA and the Regulation of Advertising
\nIV. W
ebsites &\; Social Media
\nFDA Policies on the Internet
\nRec
ent FDA Enforcement Activities
\nHow to Handle at the Company Levels<
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\n\nDay 02(8:30 AM - 4:30 PM)
\n\nV. Enforcement Trends
\nFDA Hot Buttons
\nUnderstating ri
sk
\nOverstating effectiveness
\nFTC
\nPOM Wonderful and su
bstantiation
\nPrivate Litigation &ndash\; Understanding
\nLanha
m Act
\nState Unfair Competition
\nVI. False Claims Act and Crim
inal Liability
\nReview of Key Settlements
\n&ldquo\;Responsible
Corporate Official&rdquo\; Liability
\nVII. Handling at the Company
Level
\nCompliance Programs
\nInternal processes
\nSPEAKER
\n\n
Michael A Swit\, E
sq.
\nFDA Lawyer
Michael A. Swit focuses on solvin g the legal challenges confronted by the pharmaceutical\, medical device\, and other life sciences industries in tackling the myriad of legal mandat es enforced by the U.S. Food &\; Drug Administration. Mr. Swit has exte nsive experience counseling life sciences firms on the demands of complian ce with FDA'\;s statutory and regulatory requirements to develop and ma rket safe and effective drugs\, biologics\, medical devices\, IVDs and oth er products. He also has advised regulated firms on a wide range of FDA re gulatory matters\, including drug and device approvals and marketing/promo tional claims\, dietary supplement health claims and regulatory issues in corporate acquisitions. His experience includes FDA development strategies \, compliance and enforcement initiatives\, recalls and crisis management\ , submissions and related traditional FDA regulatory activities\, labeling and advertising\, and clinical research efforts.
\n\nMr. Swit has b een addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP\, Mr. Swit served for seven years as vice presid ent at a preeminent scientific and FDA regulatory consulting firm\, where he developed and ensured execution of a broad array of regulatory and othe r services to clients\, both directly and through outside counsel.
\n\nHis multi-faceted experience includes serving for three and a half year s as corporate vice president\, general counsel and secretary of Par Pharm aceutical\, a prominent\, publicly-traded\, generic drug company and\, thu s\, he brings an industry and commercial perspective to his work with FDA- regulated companies. While at Par\, he spearheaded Par'\;s successful r esponse to multiple federal and state criminal and civil investigations ar ising out of the actions of prior management. Mr. Swit then served for ove r four years as CEO of FDAnews.com\, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulate d community. His private FDA regulatory law practice also has included ser vice as counsel in the FDA practices of three international law firms\, as well as a solo FDA practitioner.
\n\nMr. Swit has taught and writte n on a wide variety of subjects relating to FDA law\, regulation and relat ed commercial activities\, including\, since 1989\, co-directing a three-d ay intensive course on the generic drug approval process and editing a gui de to the generic drug approval process\, Getting Your Generic Drug Approv ed. A former member of the Food &\; Drug Law Journal Editorial Board\, Mr. Swit also has been a prominent speaker at numerous conferences sponsor ed by such organizations as the Food &\; Drug Law Institute (FDLI)\, th e Regulatory Affairs Professionals Society (RAPS)\, and the Drug Informati on Association (DIA).
\n\nMr. Swit is a 1982 graduate of Emory Schoo l of Law and a magna cum laude graduate of Bowdoin College (1979)\, with h igh honors in history.
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\n\nPlease contact the even
t manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:
\n-
Multiple participant discounts
\n- Price quotations or visa invitati
on letters
\n- Payment by alternate channels (PayPal\, check\, Wester
n Union\, wire transfers etc)
\n- Event sponsorships
\n
\nN
O REFUNDS ALLOWED ON REGISTRATIONS
\nService fees included in this li
sting.
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