Addressing Regulatory and Compliance Risks During the Product Launch Pre-Approval Period

Since 2003 when the Office of Inspector General (OIG) of the Department of Health and Human Services first issued its guidance to pharmaceutical manufacturers outlining the basic requirements of an effective compliance program, research-based companies have had to continue to focus on a myriad of activities that required careful compliance, legal and regulatory review.

In this two-part webinar program addressing issues facing pharmaceutical companies, Howard Dorfman, an industry authority with more than 40 years’ experience in healthcare compliance and regulatory oversight, will provide an analysis of pre-approval industry activities that present increased risk to companies even before a product enters the market. The webinar will identify various processes and procedures that impact corporate behavior during this critical period, including interactions with HCPs and the need to present accurate data to a variety of audiences and thereby avoid misstating results of studies that can present potential risks.

The second part of the webinar series will focus on the data accuracy issues in more detail. More information about this webinar will be announced at a later date.