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FDA Scrutiny of Promotion and Advertising Practices 2017

Start Date:
Thursday, 30 November, 2017
End Date:
Friday, 1 December, 2017 6:00pm
Nephrology, Immunology, Hepatology, Infectious Disease, Internal Medicine, Emergency Medicine, Family Practice, Physical Medicine

Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, 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 marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach.

Policing social media has become a new regulatory responsibility 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 you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles.

Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA.

Valid off-label information may take the lead in that direction.This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work.

You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices. Learning Objective: Learn how FDA faces constitutional constraints on enforcement decisionsLearn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety CommissionLearn how the FDA interprets advertising and promotion in principle and in factUnderstand ways that a firm violates FDA requirementsEvaluate advertising and promotional material based on interactive group hypotheticalsSee how sales and marketing departments play a central role, for better or worseLearn how the federal government holds executive management responsible for missteps in promotion and advertising practices.

Who Will Benefit: Sales and Marketing executives and managersRegulatory ManagersIn-house Legal Counsel and Contract Specialists3rd party consultantsVenture CapitalistsInvestorsBusiness Acquisition ExecutivesOwners of New or Developing FirmsOwn label distributorsInternational Trade ManagersProduct specification developers Background FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that 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 tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA.

It has become very complicated and 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 what is a problem, what is not a problem and what becomes a risk laden judgment call. Agenda: Day 1 Schedule 8:30 AM - 9:00 AM: Registration9:00 AM - 10:30 AMLecture 1: FDA legal authorityFDA application of the FD&C Act and implementing regulationsFTC / mass mediaSEC/False statementsDOJ / False ClaimsEnforcement authority and optionsCognitive psychology vs. psychoanalytic motivation10:30 AM - 12:00 PMLecture 2: Promotion and Advertising: scope of labelingDefinitions for "label" and "labeling"Hard copy and electronicTestimonialsBlogsSales forceWhat is "off-label?"Practice of Medicine exemptionDrugs authorityDevicesDietary supplements12:00 PM - 1:00 PM Lunch1:00 PM - 2:30 PMLecture 3: Supreme Court / commercial free speechConstitutional protection and case lawAmarin Case: off-label, but trueSafe harborPolicyFDA organizational responsibilityFDA Guidance2:30 PM - 2:45 PM Break2:45 PM - 4:30 PMFair and balanced disclosureSocial mediaDirect to Consumer AdvertisingHypothetical WorkshopDay 2 Schedule9:00 AM - 10:30 AMLecture 1: Direct to consumer advertising vectors Federal Trade Commission interest (economic vs. safety) Context and format of messaging Script versus messageTarget populationAspirationsEmotional factors10:30 AM - 12:00 PMLecture 2: False and misleading informationStatutory basis (21 U.S.C. 352(a))New useComparative claimsClaims for safety and effectivenessSales for solicitation12:00 PM - 1:00 PM Lunch1:00 PM - 2:30 PMLecture 3: Off label use - practices and policy FDA Warning Letters2:30 PM - 2:45 PM Break2:45 PM - 4:30 PMLecture 4: Practice of medicine exemption Custom Device promotion (Group Hypothetical) Corporate management responsibility SpeakerCasper Uldriksex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA.

He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed.

Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Location: Chicago, ILDate: November 30th & December 1st, 2017 and Time: 9:00 AM to 4:30 PMVenue: Four Points by Sheraton Chicago O'Hare 10249 W Irving Park Road, Schiller Park, IL 60176, United States Price: Price: $1,295.00 (Seminar Fee for One Delegate)Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register now and save $200. (Early Bird)Until October 20, Early Bird Price: $1,295.00 From October 21 to November 28, Regular Price: $1,495.00Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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