Since 2009, FDA has drastically increased its compliance and enforcement activities in all areas. The clinical studies arena in particular has seen a dramatic boost in agency efforts to ensure GCP compliance to both protect human subjects and ensure the reliability of clinical data.

In this audio conference, we examine the major recent FDA enforcement actions involving clinical studies. Our speaker reviews the key warning letters and 483's (inspection reports) that are the main weapons in FDA's enforcement toolkit, to identify those prime areas of concern for the agency when looking at clinical trials.

Now, more than ever, the success of clinical studies depends on compliance with FDA requirements. By exploring where others have gone wrong, conference attendees will be better prepared to have their clinical studies survive FDA's targeting if and when it arises, whether during the study or, eventually, as part of the submission review process.

This audio conference covers:

• FDA's enforcement weapons and how it uses them
• What FDA has focused on during the last year when taking enforcement against clinical study activities
• How to respond to FDA’s enforcement activities should its aim swing in your direction
• What can happen to your company or your application should you run afoul of FDA’s enforcement actions
• How to be better prepared before FDA visits

About the speaker:

Michael A. Swit, Esq. is a Vice President at The Weinberg Group Inc., a premier international scientific and regulatory consulting firm based in Washington, D.C., where he develops and ensures execution of an array of regulatory and other services for pharmaceutical, biologics, therapeutic biotech, device, IVD, and other life sciences companies, both directly and through outside counsel. Mr. Swit has been tackling critical FDA legal and regulatory issues since 1984.

His experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical. He then served for over four years as CEO of FDAnews.com. His private FDA regulatory law practice included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the FDA practice at McKenna & Cuneo. He first practiced FDA law in the D.C. office of Burditt & Radzius.

Mr. Swit has lectured and written on a variety of subjects relating to FDA law, regulation and related commercial activities and is a former member of the Food & Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high honors in history, from Bowdoin College, and his law degree at Emory University School of Law. Mr. Swit is admitted to the California bar and is an inactive member of D.C. and Virginia bars.

Who should attend?

• Directors of Clinical Operations
• Managers of Clinical Operations
• Directors of Clinical Affairs
• Managers of Clinical Affairs
• Quality Assurance
• Regulatory Affairs
• Directors of Medical Affairs
• Managers of Medical Affairs
• Pharmacovigilance
• R&D