ComplianceOnline and FDA Lawyer, Michael A Swit, Esq. will conduct a two day seminar on Advertising and Promotional Requirements for Drugs and Medical Devices.
PALO ALTO, CA, USA, October 17, 2018 /EINPresswire.com/ — Led by well-known FDA Lawyer Michael Swit, ComplianceOnline’s Live Seminar on Advertising and Promotional requirements for drugs and medical devices returns to Boston in 2018. The two-day training program will address in detail FDA requirements for drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
Given the endless updates in the regulated industry, each session in the seminar will discuss these industry updates and focus on best practices to avoid Warning Letters and other regulatory enforcement actions.
The seminar will cover topics such as distinctions between labels, labeling and advertising, and how that impacts FDA's powers, how to properly position Direct-to-Consumer (DTC) promotions, the Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter, the perils of off-label promotion and much more.
The 2016 & 2017 participation for this event from various healthcare and pharma organizations, such as Health Canada, Depomed, Pfizer, Dr Reddy's Laboratories, SSCOR, Inc., GSK, Grifols Diagnostic Solutions, Inc., Gilead Sciences, Adamas Pharmaceuticals, Inc. and others, have made the event an industry platform to reckon with.
Seminar instructor Michael A. Swit, Esq., has been tackling critical FDA legal and regulatory issues since 1984. 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. Mr. Swit has lectured and written on a variety of subjects relating to FDA law, regulation and related commercial activities and is a former member of the Food & Drug Law Journal Editorial Board.
This in-person training will assist sales, marketing, medical affairs, legal, regulatory, and compliance professionals within an organization.
For more information or to register for the seminar, please visit our website.
DAY 01 Agenda (8:30 AM – 4:30 PM)
I. Understanding the Basics (Who Has Jurisdiction,Labeling vs. Advertising, Device rules, DTC advertising, Comparative Claims, Detailing and Sampling, How FDA learns of violations)
II. Scientific Exchange (Guidances on Dissemination of Scientific Information, Risks involved in Off-Label Statements, Procedural Requirements and Unsolicited Requests for Information)
III. First Amendment (Understanding “Commercial Speech” Doctrine, FDA and the Regulation of Advertising)
IV. Websites & Social Media (FDA Policies on the Internet, Recent FDA Enforcement Activities, How to Handle at the Company Levels)
DAY 02 Agenda (8:30 AM – 4:30 PM)
V. Enforcement Trends (FDA Hot Buttons, FTC, Private Litigation – Understanding)
VI. False Claims Act and Criminal Liability (Key Settlements,Responsible Corporate Official Liability)
VII. Handling at the Company Level (Compliance Programs, Internal processes)
Dates: Thursday, November 1, 2018 (8.30 AM- 4.30 PM) and Friday, November 2, 2018 (8.30 AM- 4.30 PM)
Location: Boston, MA
Registration Cost: $1,599.00 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to firstname.lastname@example.org
For more information on ComplianceOnline or to browse through our trainings, please visit our website https://www.complianceonline.com
ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at https://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.
Source: EIN Presswire