Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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An ORCA Lunch & Learn Event - Humanitarian Device Exemptions
TOPIC: HUD to HDE to Market - Orphan Drugs with Buttons
TOPIC DESCRIPTION: In the world of drugs, we have orphan drugs. In the world of medical devices, we have humanitarian use devices. The humanitarian device exemption is the pathway to get products intended to treat a very small portion of the population to market. In this presentation, Professor Hammond will discuss the history of the Humanitarian Device Exemption, the overall pathway, and the realities of bringing a device for an orphan disease to market.
SPEAKER: David Hammond
SPEAKER BIOGRAPHY: David Hammond has worked in the FDA regulated field for 25 years. He started as a clinical research coordinator first in Boise, Idaho and then in Seattle. After deciding it was time for a change, he moved to the medical device industry. While working as a clinical research associate for a Class 3 medical device trial, he found that he really enjoyed things that plug in to things that you swallow (DISCLAIMER: he does not recommend swallowing the things that are plugged in). He spent the next decade working for a series of medical device companies and through a series of job changes that he thought were well thought out, but were viewed by his parents as the sign of someone who gets bored easily.
He found himself unemployed in 2008 after being laid off when his employer underwent downsizing. This led to Dave deciding that his next adventure would be consulting, so with absolutely no planning, he began consulting with local biotechnology companies until, as he said, he found a real job. Thirteen years and zero real jobs later, he still consults among other activities.
Dave is currently the principal consultant (well, really the only consultant) at Hammond Clinical Trial Consulting and an Associate Teaching Professor and the Academic Director of the BRAMS (MS in Biomedical Regulatory Affairs) program at the University of Washington, where he gets to tell bad jokes to students and they have to laugh if they want to pass. He is also an ardent collector of letters after his name currently holding a personal best of thirty-seven and a fictional lordship in Scotland. Dave has a BS in Zoology from the University of Idaho and a Master's in Biomedical Regulatory Affairs from the University of Washington.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification /continuing education from the following organizations:
| 1.5 pts |
RAC recertification from RAPS |
| 1.5 CEUs |
CCRP recertification from SOCRA |
| 1.5 CEUs |
CIP recertification from PRIM&R |
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.
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