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.
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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------------------------------
Original Message:
Sent: 19-Apr-2019 10:56
From: Alyssa Roelli
Subject: Upcoming FDA Regulatory Education for Industry (Free Training)
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
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| 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 > |
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"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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