viernes, 24 de agosto de 2018

CDRH Experiential Learning Program (ELP) - Seeking Sites to Participate in 2018 – Open: August 24, 2018 – September 26, 2018



CDRH Experiential Learning Program (ELP) - Seeking Sites to Participate in 2018 – Open: August 24, 2018 – September 26, 2018

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) announces the 2018 Experiential Learning Program site visit proposal solicitation period.  The 2018 ELP submission period is currently OPEN from Friday August 24th, 2018 - Wednesday, September 26th 2018 at 12 pm EST!

The ELP is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and healthcare facilities to observe how medical devices are designed, developed, and utilized.

The Program provides FDA staff with opportunities to better understand policies, laboratory practices, patient input and quality system management.  The ELP is a collaborative effort to enhance communication and facilitate the medical device review process.  The Center is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices.

CDRH is inviting medical device companies, academia, and healthcare facilities to participate in this formal training program.  Details of the program can be found on the ELP Website, which provides the background, overview and summary, as well as the list of training needs, and the application and proposal submission process. The training needs will be updated quarterly allowing for proposals to be submitted within the submission timeframes as specified on the ELP Website.

If you have questions regarding the Experiential Learning Program, please contact the ELP Program Manager, CDRH/OCE Division of Employee Training and Development via email or phone (240) 402-2246.

Thank you for your support.
Food and Drug Administration
Center for Devices and Radiological Health

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