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18 - 19 Mar 2021 • 

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

About11Sessions1SpeakersExhibitorsReviews2Photos

Estimated Turnout

100
Delegates
Based on previous editions

Editions

Mar 2021
+2 more editions

Frequency

Bi-annual
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Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the .. Read more regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Highlights

  • How to properly position Direct-to-Consumer (DTC) promotions
  • Whether the First Amendment provides any insulation for truthful statements
  • The distinctions between labels, labeling and advertising and how that impacts FDA's powers
  • The basics of FDA law and regulations governing advertising and promotion
  • The basics of FDA law and regulations governing advertising and promotion
3   Different Located Editions
Minneapolis, USA14 - 15 Nov 2019
San Diego, USA08 - 09 Aug 2019
1 Followers
Cambridge, USA09 - 10 Nov 2017
3 Followers
Filter By
Registration
Registration
Workshop
Understanding the Basics
Who Has JurisdictionDrugs & BiologicsRx Drug AdvertisingOTC Drug AdvertisingDevice
Break
Lunch
Workshop
Scientific Exchange
Guidances on Dissemination of Scientific InformationRisks involved in Off-Label StatementsProcedural Requirem
Workshop
First Amendment
Understanding “Commercial Speech” DoctrineFDA and the Regulation of Advertising
Workshop
Websites & Social Media
FDA Policies on the InternetRecent FDA Enforcement ActivitiesHow to Handle at the Company Levels
Workshop
Enforcement Trends
FDA Hot ButtonsUnderstating riskOverstating effectivenessFTCPOM Wonderful and subst
Break
Lunch
Workshop
False Claims Act and Criminal Liability
Review of Key Settlements“Responsible Corporate Official” Liability
Workshop
Handling at the Company Level
Compliance ProgramsInternal processes
Closing Ceremony
Closing Speech
Speaker
Michael A Swit

Michael A Swit

Principal, Law Offices of Michael A. Swit
8665 USD Special Group Discount Register for Six In Case of any query please call @ +1-888-717-2436 or email us @ customercare@complianceonline.com
1699 USD Seminar One Registration In Case of any query please call @ +1-888-717-2436 or email us @ customercare@complianceonline.com
Disilwa Seth

Disilwa Seth

Student at Dr. Shyama Prasad Mukherjee university Ranchi

Ranchi, India
Souzan Bakdoones

Souzan Bakdoones

Pharmacist at Student

Jeddah, Saudi Arabia
Wendy Johnstone

Wendy Johnstone

Nurse at GV Health

Shepparton, Australia
Owais Ahmad

Owais Ahmad

Business at Safa Trading

Srinagar, India

Audience Profile

Doctor
Manager
Owner
Managing Director
Cosmetologist

Audience Spread

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