Social Media and Online Marketing in FDA-Regulated Companies: What You Need to Know to Prepare for Upcoming FDA Guidelines

Presented by Vernessa Pollard

Recorded On: Thursday, August 05, 2010

Duration: 90 minutes

PURCHASE:

ONLINE

CD and Transcript ($400.00)
On-Demand ($325.00)

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RECORDING HIGHLIGHTS:

Webpages and social networking sites are changing the way Americans obtain information on medical products. While marketing in these formats can garner positive attention for pharmaceutical and medical device companies, it can also pose serious risks.

The emergence and growth of the online realm has raised a host of new issues for marketers, such as who is responsible for product-related messaging and how reporting and regulatory obligations are defined.

Industry’s efforts to leverage online promotions and the FDA’s efforts to regulate them present a new set of legal and regulatory challenges for medical marketers and the lawyers and regulatory professionals who advise them.

With the FDA expected to release new guidelines pertaining to online marketing and social media this year, it is essential to begin preparing now. In this 90-minute audio conference, industry attorney Vernessa Pollard will explain how to effectively incorporate online marketing into your product marketing strategies while maintaining regulatory compliance.

Learning Points and Questions To Be Answered:

Learn the key compliance and regulatory challenges for Web 2.0
Understand the FDA’s approach toward the use of the Internet and social media
Gain insight into what is expected from the FDA’s upcoming guidelines on the Internet and social media
Examine practical strategies to improve communications and manage regulatory risks for:
Branded websites
Unbranded patient websites
Ads on third-party websites
Blogs
Wiki
Social networking websites

Attendees Who Will Benefit From This Audio Conference Include:

ANYONE using online marketing at an FDA-regulated company
Corporate executives and directors
Legal counsel
Corporate compliance officers
Regulatory professionals
Marketing professionals
Sales professionals

YOUR EXPERT(S):

Vernessa Pollard
Vernessa Pollard is counsel in Arnold & Porter LLP's FDA and healthcare practice group, where she represents clients in FDA and DOJ investigations and enforcement matters, and counsels companies on product approval issues, advertising and promotion, and more. Vernessa spent six years as Associate Chief Counsel for Enforcement in the Office of Chief Counsel at the FDA, where she represented the agency on enforcement actions and defensive litigation matters. While there, she advised agency clients and DOJ lawyers on a wide range of compliance and regulatory matters. Among the highlights of her tenure at the FDA, she represented the agency in an enforcement action that resulted in a consent decree of permanent injunction against a leading medical device company. She also handled the FDA's first administrative action seeking civil money penalties for violations of MDR requirements and defended legal challenges involving the FDA's interpretation of the "intended use" doctrine. During her tenure at the FDA, Vernessa received several recognitions and honors, including the FDA Commissioner's Award of Excellence (2008) and the Commissioner's Award for Outstanding Service for Outstanding Legal Representation (2005). Vernessa earned her J.D. from the Temple University School of Law.