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    RE: Protocol Amendment vs. New Protocol

    By: David Lim , 8 hours ago
    Posted in: Regulatory Open Forum

    Dear A, As for new protocol, please refer to 21 CFR 312.30(a) - a study not covered by a protocol in your ongoing IND. Regarding (non)significant changes in a protocol via protocol amendments, please refer to 21 CFR 312.30(b) Thank you. s/ David ______________________________________________ ...

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    World MedTech Regulatory Update (Focus on European ...

    By: Susan Hamann , 10 hours ago
    Posted in: RAPS Boston Chapter

    World MedTech Regulatory Update World MedTech Regulatory Update 8 June 2017 8:00 am–3:00 PM EDT Massachusetts Medical Society Waltham, MA Registration Fee: $175 More Information: Dear Colleague, The same organizations that bring you the Annual FDA Update program each December-ASQ Biomedical Division/New England Discussion Group, MassMEDIC and ...

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    Application Fee

    By: Anonymous Member , 12 hours ago
    Posted in: RAPS 2017 Fellows

    This message was posted by a user wishing to remain anonymous Please explain the purpose of the $100 application fees for processing requests for eligibility as a RAPS Fellow.  Why wouldn't the membership fee collected annually from all members be used to cover expenses for the RAPS Fellowship program? Shouldn't RAPS be concerned about the impression ...

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Martha Brumfield Discusses Her Regulatory Career Path

"In addition to professional enrichment, the job of a regulatory professional is personally fulfilling. While our work may be separated from the clinics and doctors' offices where the products we support are used, in the back of every regulatory professional's mind is the knowledge that the work helps people live healthier lives. Every step of the way, we are fighting for patients."" 

– Martha Brumfield, PhD 

 

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