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Key Regulatory Topics: The eCTD 2014 RAPS: The Regulatory Convergence RAPS Learning Solutions RAPS Store - The source for regulatory knowledge RAPS Executive Development
Key Regulatory Topics: The eCTD
2014 RAPS: The Regulatory Convergence
RAPS Learning Solutions
RAPS Store - The source for regulatory knowledge
RAPS Executive Development

RAPS & Regulatory

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. Read more »

 Upcoming Events
Event: Webcast

Webcast
Utilizing Critical Security Controls to Secure Healthcare Technology
23 April 2014 | Online

Event: Chapter

Chapter Event
Key Enforcement, Legal, Regulatory and Policy Updates
24 April 2014 | Bridgewater, NJ

Event: Chapter

Chapter Event
Spring Networking Reception
24 April 2014 | Sandy Springs, GA

Event: Advertising, Promotion and Labeling: the US Regulated Environment

Virtual Program
Advertising, Promotion and Labeling: the US Regulated Environment
30 April 2014 | Online

Event: RAPS Executive Development

Workshop
RAPS Executive Development
2–5 June 2014 | Evanston, IL

Event: 2014 RAPS: The Regulatory Convergence

Conference
2014 RAPS: The Regulatory Convergence
27 September–1 October 2014 | Austin, TX


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 Community
Join the discussion -- RAPS Regulatory Exchange

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/20/2014 4:40:29 PM
From : Discussion Post>>Regulatory Open Forum
This is applicable for devices. Not necessarily! You can do either way. I recommend you separate studies done in house and those biocomp studies done under GLP. It is preferable to perform some studies/characterization in a la...

RE:Regulatory Assessment in Change Control -
Posted: 4/20/2014 4:27:50 PM
From : Discussion Post>>Regulatory Open Forum
"in many cases RA simply lack the technical and scientific knowledge and understanding to assess the impact of a change." And conversely, operations personnel simply lack the regulatory knowledge and understanding to assess the regu...

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/20/2014 4:00:40 PM
From : Discussion Post>>Regulatory Open Forum
Yes, Shayne, that is exactly the "project time" to which I am referring. It will be impossible to come up with a tight estimate, but I still need an estimate to work with, and the only way I know how to get it is to see what experien...

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