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  • 1.  Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 04-Mar-2019 11:46

    Hi RegEx Members,

    Mark your calendars: to support the release of the  Quarterly Regulatory Focus Article Series, "Risk Management Principles: A Global Perspective," we will be hosting an Ask Me Anything Session next Wednesday 13 March, from 1:30 PM-2:30 PM EST here on RegEx. This article series covers the latest risk management principles. Three risk management experts, Darin Oppenheimer, Meredith Smith <g class="gr_ gr_18 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="18" data-gr-id="18">and</g> Ann Walsh will be available to discuss the articles and answer your questions in a <g class="gr_ gr_15 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="15" data-gr-id="15">real time</g> discussion thread.

    Can't make the session? No worries-the full discussion will be available on RegEx afterward. Also, feel free to submit your questions beforehand by replying to this thread or by sending me an email at regex@raps.org.

    Looking forward to seeing your questions and to a great discussion next week!

     

    Best,

    Emily



    ------------------------------
    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
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  • 2.  RE: Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 09-Mar-2019 12:32
    ​HI, This is Anne Walsh, one of the experts for Wednesday's session.  I'm a lawyer at Hyman, Phelps & McNamara, an FDA boutique law firm in Washington, DC.  I look forward to receiving your questions!

    Anne

    ------------------------------
    **************************
    Anne K. Walsh
    Hyman, Phelps & McNamara, P.C.
    700 Thirteenth St., N.W., Suite 1200
    Washington, D.C. 20005
    awalsh@hpm.com
    Direct: (202) 737-4592
    Fax: (202) 737-9329
    Cell: (202) 834-2462

    See HPM's FDA Law Blog: http://www.fdalawblog.net/
    ------------------------------

    Original Message


  • 3.  RE: Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 11-Mar-2019 09:13
    Two questions I frequently have to answer are:  (1)  Does the P1/P2 probability estimation method recommended by ISO 14971 help me with meeting EU MDR requirements for risk management (especially as it regards the requirement for better post-market feedback into risk management)?; (2) How do I address software risk management more effectively than just considering severity since this could lead to over-mitigation of highly unlikely hazardous situations?

    I have guidance I provide in both of these areas, but I would be very interested in your perspective as well.

    Thanks!

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    Eric Henry
    King & Spalding
    Washington DC
    United States
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    Original Message


  • 4.  RE: Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 12-Mar-2019 14:37
    ​Hi, my name is Meredith Smith.  I am Global Risk Management Officer at Amgen, Inc., in Thousand Oaks, California.  My work focusses on developing risk management strategies to support safe and appropriate use of drug products once they have received marketing authorization approval.  I'm looking forward to engaging with you on this forum and responding to your questions.

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    Meredith Smith
    Thousand Oaks CA
    United States
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    Original Message


  • 5.  RE: Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 13-Mar-2019 12:55
    ​Are there any resources available to guide the development of risk minimization tools to minimize medication errors associated with drugs intended for use in pediatric patient populations?

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    Meredith Smith
    Thousand Oaks CA
    United States
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    Original Message


  • 6.  RE: Ask Me Anything Session Wednesday 13 March at 1:30 PM EST

    Posted 13-Mar-2019 12:56
    ​For the purposes of characterizing a risk associated with a product indicated for pediatric patients, can clinical trial data from the adult indication be used?

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    Meredith Smith
    Thousand Oaks CA
    United States
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    Original Message


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