Preview this audio conference

The following is a brief excerpt from this audio conference. It is in mp3 format and will play with most media players. Please Contact Us with any questions you may have.

Click the file name to listen to the excerpt ac20080904_sample.mp3

Audio conference highlights

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

This audio conference covers:

• The scope of the FDA draft guidance on Good Reprint Practices
• The constitutionality of various clauses in the guidance
• Congressional reaction and what it means
• Tips on developing a compliance program

About the speaker:

Robert J. Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor at St. Thomas University Graduate School of Engineering and its MBA program.

Who should attend?

• Regulatory Affairs
• Marketing
• Business Development
• Senior Management
• Legal Affairs

This audio conference is rated General Interest.

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.