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IDE Submission Best Practice, and Pitfalls to Avoid – from Both Regulatory & Clinical Perspectives
May 30 @ 5:30 pm - 7:30 pm
IDE Submission Best Practice, and Pitfalls to Avoid – from Both Regulatory & Clinical Perspectives
Date: Thursday, May 30, 2024 (New Date!)
Time: 5:30pm – 7:30pm PT
Audience: Regulatory and clinical affairs professionals in medical device industry
Location: Alcon Laboratories, 20511 Lake Forest Dr, Lake Forest, CA 92630 (New Location!)
This panel discussion provides an overview of the critical elements for a successful IDE strategy and submission, focusing on best practices from both regulatory and clinical perspectives. The discussion will focus on case scenarios and pitfalls to avoid, facilitating the understanding of the content. Attendees will have the opportunity to learn from the discussions and ask questions.
Submit your questions after registration and have them answered at the event!
Learning Objectives:
- Overview of IDE submission process
- Best practices of IDE submission and common pitfalls to avoid
- Navigating the review process
- Now you’re approved…what to expect.
Agenda:
- 17:30 Check in, light dinner & social networking
- 18:00 Introducing OCRA and speakers
- 18:10 Panel Presentation and Q&A
- 19:10 Open discussion & social networking, other announcements
- 19:30 Adjourn
Register now to secure your spot and empower your team for success!
About the Speakers:
Magda Michna, Ph.D., Chief Clinical, Regulatory and Medical Affairs Officer at STAAR Surgical Company
Dr. Michna brings extensive expertise in global clinical, regulatory, and medical affairs. Previously, she held key leadership roles at AcuFocus Inc. (a subsidiary of Bausch & Lomb), Presbia LLC, and within Alcon’s surgical franchise. With a focus on accelerating market entry and driving adoption, Dr. Michna has spearheaded the development of premium intraocular lens and surgical device technologies. Her strategic leadership and deep understanding of regulatory landscapes have facilitated successful market introductions.
Laura Schall, Director, Clinical Affairs at STAAR Surgical Company
Laura Schall brings extensive experience in clinical research that spans the sponsor and clinical investigator perspectives. Laura started her research career as a Clinical Research Coordinator at a private medical practice, where she was responsible for the execution of clinical studies. Laura transitioned to the sponsor side, first as part of a Clinical Research Organization (CRO) before she made the leap into industry, where she has led the strategy and execution of multiple registration and post-market clinical trials. Laura’s extensive knowledge of clinical research has led to multiple successful product registrations.
In-Person Ticket
$20 for Member
$35 for Nonmember
Light fare & beverage provided at 5:30pm PST.
Register for your team of 5+ participants? Please email programs@ocra-dg.org.
Thank you to our Sponsors!
