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Old 02-19-2012, 11:03 PM
Perryc Perryc is offline
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Join Date: Aug 2006
Location: Washington DC
Posts: 77
15 yr Member
Perryc Perryc is offline
Junior Member
 
Join Date: Aug 2006
Location: Washington DC
Posts: 77
15 yr Member
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Quote:
Originally Posted by Jim091866 View Post
How do get PWP on board with something like this. It seems pretty hard in that they would not simply take volunteers to sit in on these discussions.
Jim,
if i understand you correctly, the FDA selects people who are capable of understanding the science enough that they can evaluate the data presented. The vast majority of PWP consultants to the FDA have Doctoral level training or significant medical background plus their life experience. Patient representatives must also demonstrate some connection to the PD community of patients to be aware of how PWP view the promise of the treatment in terms of the mechanism of action and its likely effect on disease process and symptoms that matter to PWP. The Office of Special Health Initiatives (OSHI) provides on going training on FDA law and procedure, and collaborates with patient advocates [Parkinson Pipeline Project] to keep the patient consultants up to date on science and the interests pf PWP.

Perry
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"Thanks for this!" says:
Conductor71 (02-25-2012)