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Evaluation ViewAttendees 12

Preconference Workshop

Devices (includes Medical Devices and In Vitro Diagnostics)

Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, September 17, 2024
8:30 AM – 4:00 PM PDT
Location/Room: 102
Additional Registration Fee
Defining and maintaining a global regulatory strategy for a medical device or an In Vitro diagnostic is considered to be a major challenge for Regulatory professionals. In order to help regulatory professionals overcome this challenge, proven methods and adapted processes exist. The workshop will address the key stages of the construction and implementation of the regulatory strategy:

  • Basics of Regulatory Strategy for U.S. and E.U.

  • How to gather and analyze regulatory and market intelligence

  • Develop a regulatory compliance strategy for the U.S. and E.U.

  • How to adapt a regulatory strategy over time taking into account changes in the regulatory framework or in the market


A large part of the workshop will be dedicated to interactive group exercises. The workshop will culminate in an activity where participants develop an end-to-end regulatory strategy.



Agenda:

  • 7:00 – 8:00 AM: Breakfast & Networking for Preconference Workshops Registrants

  • 8:00 – 8:20 AM: Morning Welcome from RAPS

  • 8:30 AM: All Preconference Workshops Begin

  • 8:30-8:45 AM Workshop Introductions

  • 8:45 – 9:30 AM: Presentation 1: Basics of Regulatory Strategy for U.S. and E.U. for Medical Devices

  • 9:30 – 10:30 AM: Group Exercise 1: Building a structure and template for a global regulatory strategy

  • 10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Registrants

  • 11:00 – 11:30 AM: Presentation 2: Developing a regulatory compliance strategy for the U.S. and E.U.

  • 11:30 AM – 12:30 PM: Group Exercise 2: Gathering applicable regulations, guidance, and standards to inform your global regulatory strategy

  • 12:30 – 1:30 PM: Lunch & Networking for Preconference Workshop Registrants

  • 1:30 – 2:15 PM: Group Exercise 3: Analysis of regulatory and market intelligence, classification, and applicable requirements to complete your regulatory strategy

  • 2:15 – 3:45 PM: Group Exercise 4: Developing an end-to-end regulatory strategy

  • 3:45 PM – 4:00 PM: Wrap up and closing remarks

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

    • Learning Objectives:

    • Learn the fundamentals on how to build and develop a global regulatory strategy for the US and EU for Devices
    • Learn best practices around gathering and analyzing regulatory and market intelligence data for a regulatory strategy
    • Gain insight and an overview of the tools that can be leveraged to facilitate the development of a global regulatory strategy