How to Prepare & Conduct Pre-Submission Meetings

Have you considered soliciting feedback from FDA for your medical device? How should you approach the Pre-Submission (Pre-Sub) process? In this video you'll learn step-by-step best practices and methods for preparing your formal application and conducting the meeting with FDA.

Learn from Isabella Schmitt, Regulatory Affairs Consultant at Proxima Clinical Research, about FDA's Pre-Submission, a section of the FDA Q-Sub program, and take advantage of the many benefits Pre-Subs can offer, such as:
— Improved quality of subsequent application
— Enhanced transparency of the review process
— Smoother review process
— Shorter total review times
— No fees

★ KEY VIDEO TAKEAWAYS★
— Actionable tips for creating the best packet possible
— How to avoid common pre-sub meeting pitfalls
— Strategies for conducting quality meeting
— Observed differences between divisions

This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:

1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic

The video you’re watching now is from our GO Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event:    • The Greenlight Guru True Quality Virtual S...  

Plus, download the slides for this presentation for free here: https://www.slideshare.net/greenlight...

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