|Event Name||DIA 2013 Marketing Pharmaceuticals
Wednesday, February 20, 2013
Thursday, February 21, 2013
Grand Hyatt Washington at Washington Center 1000 H Street
|Description||Complying with the various regulatory and legal requirements remains highly challenging for pharmaceuticals, biologics, and OTC drug, and medical devices. Marketing and promoting these products has never been as important or as complex as it is now.
The Food and Drug Administration and Office of Inspector General/Department of Justice continue to take enforcement actions against companies that fail to understand or comply with the rules. In addition, there are many voluntary codes and other standards that companies must adapt to their own products.
The impending implementation of the Affordable Care Act and PDUFA V/FDASIA make the environment for companies even more challenging. Change is coming, and how drug and device manufacturers market their products will continue to evolve.
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.