February 29, 2024 - March 01, 2024
/ Europe
Event: 2-day in-person workshop organized by RAPS
Date: Thursday 29 February 2024 till Friday 1 March 2024
Time: 9:00 AM - 5:00 PM CEST
Location: Hilton Rotterdam, The Netherlands
Introduction
The Regulatory Affairs Professionals Society (RAPS) Rotterdam workshops will bring together leading experts in the medical device, IVD, and cybersecurity industries.
This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.
Compiling regulatory dossiers for device registrations is time-consuming and expensive. With the constant changes in the regulatory landscape, it is good to know the expectations and receive FDA feedback for regulatory strategy including predicate selection, technical or analytical validation and clinical evidence prior to conducting verification, validation, and clinical studies. The U.S. Food and Drug Administration (FDA) offers several mechanisms through which a manufacturer can directly request feedback from the FDA regarding proposed study designs and strategies for medical devices/IVDs as part of their Q-submission program.
Learning Objectives
- Identify the Q-submission options offered by the FDA for obtaining direct feedback on proposed devices and recognize when the different types of Q-submissions can be used
- Construct meaningful questions to obtain the necessary feedback to move forward with the next steps in the regulatory pathway
- Describe the content necessary to complete the different types of Q-submissions
- Apply learning to example devices and scenarios
- Case studies will include both medical and IVD device examples.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend?
Regulatory Affairs Professionals
Agenda
Day 1- 29 February 2024
- Introduction to FDA’s Q-submission Program – What is a Q submission? What types of Q-submissions are available?
- Q-submission process – How do I work with FDA to submit, correspond, and close out my Q-submission?
- How to effectively use Q-submissions in your regulatory strategy and tips for successful Q-submissions
- Case study exercise – Determine regulatory strategy and appropriate Q-submission for example cases
Day 2 – 1 March 2024
- Contents of Q-submissions
- Q-submission feedback and meetings
- Case study exercise – determine appropriate Q-submission content and questions for FDA example cases
- Panel Q&A
Registration Fees & Deadlines
US FDA Pre-Submissions| RAPS
For more information and registration please visit the RAPS website.
The workshop will be hosted by Qserve experts who all have hands on FDA experience: