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RAPS Executive Development Understanding Regulatory Requirements for Human Factors Usability Testing 2012 RAPS: The Regulatory Convergence New Apps for Regulatory Focus 2012 RAPS Awards
RAPS Executive Development
Understanding Regulatory Requirements for Human Factors Usability Testing
2012 RAPS: The Regulatory Convergence
New Apps for Regulatory Focus
2012 RAPS Awards

RAPS & Regulatory

RAPS is the leading international membership organization for regulatory professionals who are working to ensure the safety, effectiveness and availability of healthcare products, including medical devices, pharmaceuticals and biotechnology. We are dedicated to advancing the profession and providing the highest level of support, knowledge, direction and standards to the regulatory community. Together we are making better healthcare products possible.

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Join the discussion -- RAPS Regulatory Exchange

RE:Seeking EU Device Directives Expert
Posted: 5/21/2012 10:20:28 AM
From : Discussion Post>>Regulatory Open Forum
I have received numerous responses to this post and am now going through bios to contact potential SMEs for this project or other potential course reviews. Thank you for the overwhelming response. -------------------------------------------...

RE:Measuring Submissions
Posted: 5/19/2012 11:37:10 AM
From : Discussion Post>>Regulatory Open Forum
It seems like the type of the measurements you want to track willdepend on your purpose in tracking them. For example, if you are looking for quality metrics to improve your inhouse process, I'm doubtful that tracking the branch and reviewe...

CDER Small Business Newsletter statement on eCTD
Posted: 5/18/2012 10:25:10 AM
From : Discussion Post>>Regulatory Open Forum
From the FDA/CDER Small Business Chronicles issue dated May 10, 2012, subject IND 101: "Although CDER still accepts paper IND submissions, we strongly encourage sponsors to present INDs in the electronic common technical document (eCTD) for...

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