February 21, 2023 - February 22, 2023
2-day in-person workshop organized by RAPSDate:
Tuesday 21 - Wednesday 22 of February 2023
9:00 AM - 5:00 PM CEST Location:
Holiday Inn in Munich, GermanyIntroduction
The Regulatory Affairs Professionals Society (RAPS) Munich workshops will bring together leading experts in the medical device, IVD, and cybersecurity industries.
One of the key tools for market entry in the US is to aid successful U.S. Food and Drug Administration (FDA) submissions is to use the pre-submission process to understand FDA's expectations. Qserve is teaming up with RAPS to present FDA Pre-Submissions: The Most Valuable Tool in Your US Regulatory Toolbox.
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 US.
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 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 as part of their pre-submission program.Learning Objectives
The workshop will provide participants with:
- Identify the pre-submission options offered by the FDA for obtaining direct feedback on proposed devices and recognize when the different types of pre-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 pre-submissions
- Apply learning to example devices and scenarios
Case studies will include both medical and IVD device examples.
For more information and registration please visit the RAPS Euro Event webpage.
Workshop will be hosted by Qserve experts who all have hands on FDA experience: