Washington Marriott Wardman Park , Washington, DC, USA
Feb 16 2012 8:30AM - Feb 17 2012 5:00PM
Workshop for Regulatory/Legal/Communications Professionals and Promotional Review Teams It’s not getting any easier to understand or be in compliance with all the various regulatory and legal requirements that apply to Rx and OTC drug and device promotional materials. The Food and Drug Administration and Office of Inspector General/Department of Justice continue to take enforcement actions. In addition, there are many voluntary codes and other standards that companies must adapt to their own products. The penalties for non-compliance go beyond an FDA warning letter. The substantial fines, criminal and civil legal actions and corporate integrity agreements affect how every company and vendor does business. Don’t be caught unprepared. Bring your entire promotional review team to this year’s Marketing Pharmaceuticals 2012, where, in just 2 days, you will: • Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals, biologics, and medical devices
• Receive practical, day-to-day guidance based from the latest FDA enforcement actions, as well as federal and state civil and criminal actions and settlements
• Learn about FDA guidance documents and policies currently in development or being considered
• Hear about the latest enforcement activities by the centers within FDA that regulate medical marketing: drugs (CDER), biological products (CBER), and medical devices (CDRH)
• Be informed on what’s new in Medical Policy Initiatives
• Obtain information about Substantial Evidence and other Standards
• Discuss considerations in a Multimedia World
• Attend breakout sessions designed for each member of your promotional review team to help foster a common understanding of how marketing is conducted in a highly regulated environment
Event Code:
12007
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