Overview
Allegations, Appeals, and Throwing the Least Burdensome Flag: How To Gracefully Throw A Regulatory Tantrum
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Event Agenda
DATE: Wednesday, 16 March 2022
TIME: 6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION: This is an ONLINE event on zoom virtual platform
Program Details
Everyone hopes for a smooth regulatory process, free from refusals and hold letters. Sadly, that is not always the case as many files can get stopped right out of the gate during the Refuse to Accept (RTA) process or end up being placed on a lengthy hold. There are also cases where a company does not believe it deserved the Denial, Disapproval or Not Substantially Equivalent decision meted out by the Agency.
In this presentation, you will learn about the many ways you can escalate things with the FDA, and the appropriate process to do so. While the hope is that you will never need any of the information provided in this talk, hopefully it is useful to know what recourse you have if things become stuck in regulatory purgatory. We will discuss the pros and cons of throwing the Least Burdensome Flag, best practices for a Submission Issue Request, the role of the Ombudsman, how to make an allegation, and providing examples of when the Appeal process is truly warranted.
Please email [email protected] ahead of time with your regulatory horror story if you are willing to share it anonymously with the group!
Speaker Biography
Allison Komiyama regulatory consultant focused on FDA submissions for the medical device industry. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley.
Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of device companies. Her company (AcKnowledge Regulatory Strategies, LLC) was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle.
Much of her recent work has been focused on digital therapeutics, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about Regulatory Submissions as a faculty member at UCSD extension.
She was an FDA reviewer for a brief stint from 2010-2011 and received her Regulatory Affairs Certification (US) in 2014.
Contact
Pricing – Online – Registration (Mar 04, 2022 – Mar 15, 2022)
| Registrant Type | Price |
| Member | $10.00 |
| Lifetime | $10.00 |
| Non-Member | $15.00 |
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Cancellation Policy
There will be no refunds for cancellations.
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