sábado, 13 de febrero de 2016

CDER SBIA Webinar – Pilot Clinical Outcome Assessment Compendium – March 8th, 2016

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

On Tuesday March 8, 2016; 1:00 PM ET, CDER will host a LIVE webinar titled:
 *  * Webinar Information * *
* * Register Here * *
 The pilot COA Compendium organizes and summarizes clinical outcome assessment (COA) information for many different diseases and conditions into a single resource and was recently published for public comment. FDA hopes the COA Compendium will ultimately foster patient-focused outcome measurement by facilitating communication with external stakeholders and providing clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development.
This one hour webinar will:
- Familiarize the audience with the recently announced pilot COA Compendium.
- Address questions from the audience.

Please visit following websites for additional information:
*                       *                       *                       *                       *                       *                       *
  • After registering you will receive an automatic acknowledgement with the webinar link. You will need this link to access the webinar on 03-08-14. If you don’t receive the acknowledgement, please check your spam folder.
  • There is no call in number – audio is via Adobe Connect only
  • The number of concurrent users is a maximum of 1000.
  • The Adobe Connect room will accommodate attendees on a first come first serve basis.
  • NOTE - the webinar will be recorded in its entirety and posted on this website within 7 days post event.
  • This webinar has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.
  • Please note that the credit is only available for participation in the live event and not for watching the recording afterwards.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Please take our CDER SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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