Director, Global Regulatory Affairs
Paul will be one of the distinguished presenters at the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference.
Why is the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference important to regulatory affairs executives?
Moving beyond the value of the content, these conferences provide a great opportunity to engage and interact with others in industry as well as Agency staff. The format facilitates information exchange and fosters connections, which are critical in this environment.
How has Regulatory Affairs evolved in the last several years?
Global regulatory complexity has been increasing while product development cycles are further streamlined. This confluence can have the advantage of delivering better products to the patient; however, places further demands on the regulatory professional. Accordingly, it’s critical that we be prepared to meet these challenges.
Not registered for the Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference yet? Check out some of the highlighted sessions:
- Understanding the 510k Reform & Guidelines for New and Legacy Products
Led by Paul Swift, Director, Global Regulatory Affairs at Alcon and Marjorie Shulman, Director, Premarket Notification 510(k) Program with the FDA
- A Case Study on Preparing for FDA Inspections to Meet the Increasing Regulatory Demands
Led by Vy Tran, Senior Vice President of Regulatory Affairs and Quality Systems at Varian Medical Systems
- The Industry Response & Preparation for EU Re-registration for CE Marked Devices
Gert Bos, PhD, FRAPS, Director of the Board, RAPS, the Netherlands and Hilde Viroux, Global Head EU MDR Compliance at Alcon