📢 Join the RAPS Twin Cities Chapter and our event sponsor, DuVal & Associates, PA, for dinner and an evening of learning how to strategically use the FDA Pre-Submission program most effectively to stay out of Pre-Sub Purgatory and efficiently get your product on the market! Learn practical tips from industry experts Mark DuVal, J.D. FRAPS, Lisa Pritchard and Kathy Herzog, who have been successfully navigating the Pre-Sub program since its inception, including strategies to truly listen to what FDA is saying (or not saying), and how to handle inevitable disagreements.
🗝️ Key topics will include:
📚 Pre-Sub History
⚖️ Making the Pre-Sub Decisions (To Pre-Sub or Not to Pre-Sub? Written Feedback or Meeting? Video or In-Person Meeting?)
✅ What makes a good Pre-Sub (Content, Questions, Presentation, Attendees)
🎨 The art of Pre-Sub Communications (Understanding FDA, Handling Disagreements, Avoiding Multiple Pre-Subs, Meeting Minutes)
🏫 Best practices and Lessons Learned
❓ Questions and Answers
✏️ Register here: Twin Cities Chapter In Person Event: To Pre-Sub, or Not To Pre-Sub, That Is The Question
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| Twin Cities Chapter In Person Event: To Pre-Sub, or Not To Pre-Sub, That Is The Question |
| The FDA Q-submission program offers a valuable Pre-submission (Pre-Sub) option that can enhance your regulatory strategy. Join industry experts to learn how to effectively use this tool. |
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Lisa Pritchard FRAPS
VP of Regulatory, Quality, Clinical and Engineering
DuVal & Associates PA
Bloomington MN
United States
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