Events
Duane Morris Special Counsel Michael Swit to Present at Drug Information Association 49th Annual Meeting
June 23, 2013 | Boston
| Boston Convention and Exhibition Center
Duane Morris special counsel Michael A. Swit will present at the Drug Information Association (DIA) 49th Annual Meeting. The conference takes place from Saturday, June 22, 2013 to Thursday, June 27, 2013 at the Boston Convention and Exhibition Center.
Mr. Swit will present "FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur" on Sunday, June 23, 2013, from 8:30 a.m. to 12 p.m. This tutorial will review and discuss the legal, regulatory, and practical challenges of FDA enforcement priorities for 2013 and beyond; FDA administrative enforcement weapons and how the agency uses them (e.g., inspections, warning letters, publicity, recalls, and investigator disqualification proceedings); and the civil and criminal penalties for violations. These interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.
On Tuesday, June 25, 2013, he will discuss "Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions" from 1:45 p.m. to 3:15 p.m. The seminar will discuss the types of critical regulatory, clinical and quality issues that must be reviewed before deal closing, describe how to structure due diligence teams, using internal and external resources, and how to review key issues in a cost effective manner.
Mr. Swit will present "How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)" on Wednesday, June 26, 2013 from 8:00 a.m. to 9:30 a.m. The seminar wil discuss how new technology leads to automatic Class III status for a device, even if not risky; explain how the FDAMA created a new mechanism to avoid automatic Class III status by the de novo petition process; and examine the advantages and burdens of the process.
On Thursday, June 27, he will present "Informed Consent: Promise, Pledge, Contract or Platitude?" from 10:45 a.m. to 12:15 p.m. The seminar will discuss the importance of the global requirements needed in the Informed Consent Process (ICH-GCP), identify the evolving regulatory requirements and updates and describe how to conduct effective IC monitoring according to the different country-specific differences in today's environment.
To learn more and register for the event, visit the DIA website.
