Advertising and Promoting FDA Regulated Products - Is your House in Order?

Why Should You Attend:

Are the "claims" you are making about your pharmaceutical or medical device in compliance with FDA requirements?

We've entered a period of aggressive promotional enforcement. Prosecution of off-label marketing has heated up. Government (FDA, DOJ, OIG) has started prosecuting corporate executives and lawyers for promotional violations

This webinar will focus on promotional claims, compliance, enforcement and what you can do to protect yourself. If you work at a medical device or pharmaceutical company, you should attend this training.

Is your sales force, the materials they carry and their sales pitch in compliance? What about your company website? Is your marketing department using Facebook and Twitter? During this presentation the speakers will discuss the new enforcement reality faced by industry, and answer your questions.

Learning Objectives:

• How to make lawful claims about your drug or device.
• How you can protect yourself from promotional compliance issues.
• How to determine whether your sales force, the materials they carry and their sales pitch in compliance.
• What to look for on your company website or social media outlets that could create issues.

Areas Covered in the Seminar:

• Promotional claims.
• Update on promotional enforcement and prosecution of off-label marketing.
• Prosecution of corporate executives and lawyers for promotional violations.
• Compliance and protecting yourself.
• Reviewing your sales force, the materials they carry and their sales pitch in compliance.
• Review company websites and social media use.

Who Will Benefit:

The following professionals from regulated industries (Pharmaceutical, Medical device, Biotech, Biologics, Nutritional or Dietary supplements/Vitamin makers

Foods (if health related) and Laboratories) will benefit from this training:

• Marketing Management
• Corporate Executives
• Attorneys (In-house or Outside Counsel)
• Senior executives of pharmaceutical and device firms
• Regulatory Affairs - Vice Presidents, Directors and Managers
• Sales Vice presidents, Directors and Managers
• Compliance Management
• Sales Management
• QA managers
• Quality system auditors

Instructor Profile:

Mark DuVal, is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and 3M Drug Delivery Systems and various Medical Device Divisions working both domestically and internationally. He then worked at Medtronic in Corporate Compliance covering FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark Gardner, is an attorney with an M.B.A. that specializes in laws and regulations that impact FDA regulated products. Prior to his legal career, Mark worked in product management and sales for three medical device companies over a 10-year span. His unique background and training helps him provide practical, yet compliant counsel to his clients who manufacture drugs, medical devices, foods, supplements, biologics and perform laboratory testing.

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