Virtual Program: Advertising, Promotion and Labeling: the US Regulated Environment (2016)




  • At a Glance
  • Objectives & Audience
  • Speakers
  • Agenda
  • Registration Info

At a Glance

Date:

30 March 2016

Discounted Registration Deadline:

11 March 2016

Advance Registration Deadline:

29 March 2016
Please note that capacity for this program is limited. RAPS encourages participants to register early to confirm participation.

Cancellation Deadline:

22 March 2016

RAC Points:

5

Will this meeting be recorded?:

Yes

Registration Fees:

$495 member ($595 after 11 March)
$695 nonmember ($795 after 11 March)

Learning Objectives

Hear leaders from industry, regulatory agencies and the legal profession share their expertise through presentations, discussions and case studies. This program examines current guidelines and expectations for healthcare product advertising, promotion and labeling in the US and how they impact the way you communicate with prospective and end users.

Learning Objectives

  • Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices, drugs and biologics
  • Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion, with specific attention on FDA’s regulation of social media
  • Discover regulatory applications through case studies

Who Should Attend

  • Early to mid-level regulatory professionals involved in advertising and promotion of healthcare products for the US market
  • Regulatory consultants
  • Compliance specialists
  • Food and drug lawyers
  • Marketing representatives
  • Medical device attorneys
  • Medical communications professionals

Learning Levels: Intermediate

Speakers

Richard L. Cleland is assistant director, Division of Advertising Practices, Federal Trade Commission (FTC). Previously, Cleland was assistant to the director of the Bureau of Consumer Protection and assistant director of the Division of Service Industry Practices. His primary area of expertise is the advertising and marketing of health-related products and services. He also supervises many of FTC’s health fraud and weight-loss product and service law enforcement initiatives. Current areas of interest include immunity claims for dietary supplements and foods. Cleland recently supervised FTC’s review of the Endorsement and Testimonial Guides. Prior to joining FTC, Cleland served as special assistant attorney general and director of the Division of Consumer Protection in the Iowa Office of the Attorney General.

Dale Cooke, is president of PhillyCooke Consulting and serves on the faculty of the University of California San Francisco’s American Course on Drug Development and Regulatory Sciences. He helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Cooke is the author of Effective Review & Approval of Digital Promotional Tactics, which was published in the Food & Drug Law Institute’s primer series, and is currently writing a book about compliant social media usage.

Stefanie Doebler, JD, MPH, MA, is special counsel in Covington & Burling LLP's healthcare and food and drug practice groups. Her practice focuses on healthcare compliance matters for pharmaceutical and medical device clients. Doebler provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with healthcare professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Bradley Merrill Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC, is in the healthcare and life sciences practice in the firm's Washington, DC office and is strategic counsel with EBG Advisors Inc. There he counsels medical device and drug companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. For trade associations, Thompson has served as counsel to AdvaMed for payment issues, as general counsel to the Combination Products Coalition and as counsel and secretary for the Indiana Medical Device Manufacturers Council. He has taught food and drug law as an adjunct professor at the Indiana University Law School and Columbia Law School. Thompson also serves as co-chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association.

Agenda

12:00 pm

Opening Remarks

12:05 pm

Regulatory’s Role in Managing Intended Use and Off-Label Promotion

  • Intended use as the foundation for all promotion
  • Impact of off-label use/risk
  • Handling unsolicited requests
  • The use of journal reprints

Dale Cooke, president, PhillyCooke Consulting

12:45 pm

Claims Substantiation & Comparative Claims

  • Learning from FDA Warning and Untitled Letter

Stefanie Doebler, special counsel, Covington & Burling LLP

1:45 pm

Break

2:00 pm

Using Social Media

  • Understanding the new FDA Guidance Document
  • Incorporating social media into your marketing plan
  • Avoiding landmines in communications within social media platforms 

Bradley Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC

3:15 pm

Break

3:30 pm

Navigating Federal Trade Commission (FTC) Requirements

  • FTC organization and jurisdiction
  • New FAQs on endorsements and social media
  • Enforcement policy and guidance on native advertising
  • Health-related cases currently in litigation

Richard L. Cleland, assistant director, Division of Advertising Practices, Federal Trade Commission

4:45 pm

Concluding Comments and Questions

Registration Info

REGISTRATION FEES

Register by 11 March

Register after 11 March

RAPS Member

$495

$595

Nonmember

$695

$795

Cancellation Deadline: 22 March 2016

»Downloadable Registration Form (for registration by Mail/Fax)