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  • RAPS is seeking qualified individuals to serve on the RAPS Board of Directors for the 2024–2026 three-year term. A little bit about the RAPS Board of Directors, for those who might not know: The Board is the strategic governing and policy body of RAPS. ...

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    Adv & Promo Review Process

    This message was posted by a user wishing to remain anonymous I'm Regulatory Affairs manager for a small-ish (but growing) device manufacturer.  As one of the few original people in the company with experience in the device industry (and being in Regulatory), ...

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    DMF references for API under GDUFA III

    This message was posted by a user wishing to remain anonymous Hi, Under GDUFA, a DMF for an API needed to undergo a Completeness Assessment and have the DMF fee paid prior to being placed on the Available for Reference list.  The API DMF could only ...

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    Release of Drug Product to US market

    This message was posted by a user wishing to remain anonymous Dear RAPS community, Can a Drug Product that is registered with the FDA be released to the US market by a non-US company/site and by a person, who is not physically located in the ...

  • @Olga van Grol-Lawlor 's journey into regulatory affairs will sound familiar. She tells me didn't know what regulatory affairs was when she interviewed for her first job in the profession.    "They asked me if I knew what regulatory ...

Explore RAPS volunteer opportunities

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13-Jan-2022 Quick Task (less than 1 hour) 1  point
Online Opportunity
05-Aug-2022 Small Project (multiple days) 20  points
30-Jan-2023 Large Project (Long Term) 40  points
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30-Jan-2023 Large Project (Long Term) 40  points
Online Opportunity
23-Feb-2023 Quick Task (less than 1 hour) 2  points

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