Preconference Workshop: Expand Your Knowledge to Gain Professional Flexibility

In a time of transition for many professionals within regulatory agencies, this workshop offers an opportunity to broaden your expertise and enhance your career resilience. Whether you're navigating a career shift or looking to expand your global regulatory knowledge, this full-day session is designed to help you build a strong foundation in European Union medical device regulations.

Led by seasoned experts with experience across authorities and industry, both in U.S. and EU, the workshop will explore key topics such as CE marking, conformity assessment, post-market surveillance, and the distinct roles of authorities, notified bodies, and manufacturers in the EU.

Through a mix of presentations, real-world insights, and interactive discussions, you'll gain practical knowledge that can be immediately applied to support global product strategies or new career directions.

This workshop is tailored for U.S.-based regulatory professionals—including regulatory specialists, managers, and consultants—who are looking to broaden their expertise. Whether you're considering a career move, supporting global product registrations, or simply aiming to stay competitive in a rapidly evolving regulatory landscape, this session will provide insights and tools to help you succeed.

Preconference Workshop Agenda Outline:

• 7:30 - 8:30 am: Breakfast for Preconference Workshop Attendees


• 8:30 - 8:45 AM: Opening remarks, welcome and overview of the day (Speakers: Bassil Akra & Sabina Hoekstra)


• 8:45 - 9:15 AM: Personal Journey: Transitioning from Regulatory Authority to Industry. A candid story of professional evolution and lessons learned


• 9:15 - 9:45 AM: Authority vs. Industry Perspectives. Explore the differences in approach, priorities, and expectations


• 9:45 - 10:00 AM: Q&A and Wrap-Up. Interactive discussion to consolidate morning insights


• 10:00 - 10:30 AM: CE Marking Principles and the New Approach – Part I. Introduction to the EU’s regulatory philosophy and CE marking fundamentals (Speaker:Sabina Hoekstra)


• 10:30 - 11:00 AM: Refreshment Break for Pre-conference Workshop Attendees


• 11:00 AM - 11:30 AM: CE Marking Principles and the New Approach – Part II. Deeper dive into e.g., risk classification, essential safety and performance requirements, harmonize standards and other feature of EU regulatory system (Speaker: Bassil Akra)


• 11:30 AM - 12:30 PM: How Does the Conformity Assessment Process Work? Step-by-step walkthrough and certification pathways and of notified body involvement (Speaker: Bassil Akra)


• 12:30 - 1:30 PM: Lunch for Pre-Conference Workshop Attendees


• 1:30 - 2:15 PM: Manufacturer Obligations in the EU. What companies must do to maintain compliance throughout the product lifecycle


• 2:15 - 3:00 PM:Post-Market Surveillance, PMCF, and Vigilance Requirements. Understand the EU’s expectations for monitoring product performance and safety (Speaker: Gert Bos)


• 3:00 - 3:15 PM: Break for Pre-Conference Workshop Attendees


• 3:15 - 3:30 PM: Continued: Post-Market Surveillance, PMCF, and Vigilance Requirements. Understand the EU’s expectations for monitoring product performance and safety (Speaker: Gert Bos)


• 3:30 - 4:00 PM: Panel
  
  Discussion: All Speakers. Interactive session to address participant questions and share final reflections


• 4:00 PM: All Preconference Workshops Adjourn for Day