Overview
Join us for a brief 2021 SDRAN recap followed by a presentation:
How to Effectively Engage with the FDA through the Pre-Sub Process
Register here
Description
Program Topic:
How to Effectively Engage with the FDA through the Pre-Sub Process
Program Date:
19Jan2022
Program Speaker
Isabella Schmitt, RAC is the Director of Regulatory Affairs at Proxima Clinical Research, Inc., a contract research organization focusing on assisting emerging medical device and biotech companies in regulatory, quality, and clinical development. At Proxima, Isabella is responsible for overseeing over 100+ medical device and pharma projects. Prior to joining Proxima, Isabella served as the Senior Regulatory and Quality Manager for two medical device companies, where she outlined the regulatory strategy and put together design controls and quality documentation. As the Director of CMC and Quality at a biopharmaceutical company, she oversaw all product development and ensured CMC regulatory strategy was sufficient for filings in the US and Europe.
Outside of Proxima, Isabella is a partner, judge, mentor, and speaker for multiple healthcare accelerators, including M1 MedTech Accelerator, MedTech Innovator, TMCi, MassChallenge, gBEta, and Hatch. She also serves as a pitch coach for SXSW Pitch Competition.
Agenda
6:00 – 6:05 PM Welcome – Sasi Mudumba and Michelle Sands
6:05 – 6:30 PM Annual Meeting
6:30 – 7:30 PM Program Presentation
7:30 – 7:45 PM Q & A
Contact
Pricing – Online – Registration (Dec 22, 2021 – Jan 18, 2022)
| Registrant Type | Price |
| Member | US$ 10.00 |
| Lifetime | US$ 10.00 |
| Board Member | Free |
| Non-Member | US$ 15.00 |
Cancellation Policy
There will be no refunds for cancellations.
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