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Upcoming FDA Regulatory Education for Industry (Free Training)

  • 1.  Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 19-Apr-2019 10:56

    The FDA is hosting their annual REdI Educational Conference in May.  This conference provides valuable training and insight on the latest FDA regulations for both the drug and device industries.  You can attend live or virtually through your computer and it is free.  May 29th and 30th.  

    REdI Annual Conference 2019 | SBIA Events

    Sbiaevents remove preview
    REdI Annual Conference 2019 | SBIA Events
    The Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) invite you to interact with and learn directly from FDA's regulatory experts. This conference is designed to provide participants with a strong, basic foundation in understanding the FDA's drug and medical device regulatory requirements.
    View this on Sbiaevents >


    "The Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) invite you to interact with and learn directly from FDA's regulatory experts. This conference is designed to provide participants with a strong, basic foundation in understanding the FDA's drug and medical device regulatory requirements.  Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA. FDA speakers will be available to answer questions one-on-one at the end of each day."

    "This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion."



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    Alyssa Roelli
    Regulatory Projects Manager
    Milwaukee, WI
    United States
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  • 2.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 22-Apr-2019 08:08
    This sounds like a good opportunity- has anyone attended this previously, and could provide feedback on its value? 
    Also, do you know when an actual agenda will be available?

    thank you so much!

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    Susan Shockey RAC
    Regulatory Affairs and Quality Management
    Charleston SC
    United States
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  • 3.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 22-Apr-2019 10:54
    I have attended this event numerous times in the past.  I attend virtually through my computer and found that setup to work perfectly for me.  You can pick and chose which sessions to attend.  Some of the topics are more basic and some are more advanced.  I work in regulatory at a smaller medical device company and have learned a lot of helpful information through the years.  Sounds like they are covering some interesting new topics this year as well.  They usually release the full schedule and all the slide presentations shortly before the event.

    "Drugs track: Will focus on the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs).

    Devices track: Will address globalization, harmonization, and standardization of medical device regulation."

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    Alyssa Roelli
    Regulatory Projects Manager
    Milwaukee WI
    United States
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  • 4.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 22-Apr-2019 10:04

    ​Hi, Alyssa - thanks so much for posting!  This type of information sharing is very helpful - and a great way for our community to support each other. 

    Best,

    Cathy



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    Catherine Anderson PhD, RAC
    Associate Director - Regulatory CMC
    Hillsborough NC
    United States
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  • 5.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 24-Apr-2019 14:08
    Interesting summary description of who should attend, from a medical device perspective, IMO:

    Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission as well as globalization, harmonization, and standardization of medical device regulation.

    Agenda is not yet out, but I'll be interested to see how that gets translated into specific topics.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 6.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 25-Apr-2019 09:10
    Edited by John Minier 25-Apr-2019 09:10
    Great opportunity!

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    John Minier, RAC
    Consultant, Principal
    john@johnminier.com
    (914) 850-4432
    Highland Mills, NY
    United States
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  • 7.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 26-Apr-2019 17:22
      |   view attached
    The agenda for this event has been made available; I've attached it if anyone would like to see it!

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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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    Attachment(s)

    pdf
    REdI-2019-Agenda.pdf   259 KB 1 version


  • 8.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 26-Apr-2019 18:01
    Thanks for posting Brittany.  Looks like an interesting line-up of sessions.

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    Alyssa Roelli
    Regulatory Projects Manager
    Milwaukee WI
    United States
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  • 9.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 26-Apr-2019 18:36
    Yes, thanks for posting.  I'm more than a little surprised to see FDA portray early feasibility studies as having something to do with patient access.  Not sure what is up with that.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 10.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 05-May-2019 21:00
    Hi, 
         I am Pursuing my Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University, Boston, MA. Is there any way I can volunteer for the event ? As a student, it would be an enriching experience for me.

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    Gaurav Saawant
    Boston MA
    United States
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  • 11.  RE: Upcoming FDA Regulatory Education for Industry (Free Training)

    Posted 06-May-2019 11:56
    Guarav - the event is free and is available either in person in Boston or online. You just have to register for it.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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