Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, May 2, 2012

May 18: FDA Patient Meeting/Webinar-Register by May 4


U.S. Food and Drug Administration

Inaugural Patient Network Annual Meeting
Patient Input into FDA Benefit-Risk Decision-Making: 
Opportunities and Challenges 

 Hosted by FDA's Office of Special Health Issues (OSHI) in collaboration with the
Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER)
and the Center for Devices and Radiological Health (CDRH)

Friday, May 18, 2012
9:00 AM - 4:30 PM
(Registration opens at 8:15 AM)

 FDA White Oak Campus
Building 31, Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993

Registration Deadline is
May 4, 2012
for questions the agency hopes to have answered
FDA recognizes a need for greater understanding of how patients define and perceive benefits and risks about medical products.  The FDA Patient Network is hosting this one-day meeting to:
    • explore the drug and medical device regulatory processes;
    • discuss where patient input is practical and most valuable; and,
    • explore practical approaches to collecting meaningful patient input.
We will hold a series of presentations, exercises, and panel discussions throughout the meeting to facilitate a conversation between FDA decision-makers and the patient community about these important topics. We anticipate valuable input from meeting participants and expert panelists on:
    • ways to effectively include patient input in FDA benefit-risk decision-making; and,
    • how to prioritize diseases or conditions to approach in future benefit-risk discussions.
Who Should Attend?
Patients/caregivers and patient advocates should attend.  Members of the general public are also invited to attend, including health professional, academia, and industry representatives.
Will it be Webcast?
Yes, the meeting will be webcast. To access the webcast, please register for the event and select the appropriate option.
What is the Cost?
There is no cost to attend the meeting; however individuals are responsible for any costs associated with meals and their transportation.
* Beverages and food are not included but will be available onsite for purchase.
* The FDA is not responsible for providing electrical outlets during the workshop.
 Click the button above to attend
in person or via webcast.

No comments:

Post a Comment