More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

This audio conference covers:

• The role, structure and jurisdiction of the FDA
• How the FDA classifies life science products
• The regulatory framework for GMPs, CAPAs, and advertising and labeling
• The FDA’s enforcement authority
• Fraud & abuse basics every company should know
• The connection between regulatory compliance and fraud & abuse violations

About the speaker:

Bethany Gilbert is an attorney within the Life Sciences Group at Hodgson Russ LLP, and focuses her practice on assisting life science companies with regulatory and compliance matters. She represents these companies in all aspects of their business, from regulatory submissions such as NDAs, 510(k)s, or PMAs, to collaborative agreements for research, supply and distribution, or joint product development.

She combines her health law experience in third-party, Medicare, and Medicaid reimbursement with her life science experience to assist manufacturers and distributors with issues relating to pricing, coding, labeling, advertising, and FDA enforcement. She has assisted clients in responding effectively to FDA enforcement actions, including product liability, recalls, seizures, FDA warning letters, and other notices of alleged violation. She also assists FDA-regulated industries with both domestic and foreign regulatory compliance, including import and export issues.

Who should attend?

• In-house Counsel
• Business Development
• Marketing
• Executive Management Team
• Research and Development
• Regulatory Affairs

This audio conference is rated General Interest.