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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 & 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.

 Upcoming Events

2–4 May 2012
Advanced eCTD Submissions
Washington, DC

7 June 2012
Understanding Regulatory Requirements for Human Factors Usability Testing
Virtual Program

11–14 June 2012
RAPS Executive Development Program at the Kellogg School of Management
Evanston, IL

14–15 August 2012
Preparing Compliant eCTD Submissions
Rockville, MD

26–30 October 2012
2012 RAPS: The Regulatory Convergence
Seattle, WA

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 Community
Join the discussion -- RAPS Regulatory Exchange

RE:Off-Label Discussion in Media Interviews
Posted: 5/16/2012 10:01:09 AM
From : Discussion Post>>Regulatory Open Forum
If they are speaking on the company's behalf, or the company has arranged the media interview, then yes, they are indeed required to abide by the Guidance. If the media outlet has contacted them independently to comment, and the company has...

RE:ODT Water vs No Water
Posted: 5/16/2012 9:17:23 AM
From : Discussion Post>>Regulatory Open Forum
Hi Vikram, Yes, the reason why the ODT was taken with liquid in the BE studies was to be consistent with the comparator. There are guidance documents for recommended BE studies for specific products. There is one for carbidopa/levidopa OD...

Sterile WFI for Parenterals
Posted: 5/16/2012 7:42:53 AM
From : Discussion Post>>Regulatory Open Forum
The USP monograph for Sterile WFI states a requirement for 1L glass bottles. We wish to use 5L bags of SWFI for preparing a parenteral product. It is clear that WFI can be used for parenterals and SWFI is not required; however, the compan...

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