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July 2016

GI Coordinated Registry Network: A Case for Obesity Devices

July 29, 2016
FDA Headquarters,

Recording links Morning session: https://collaboration.fda.gov/p6eeqmva8x3/ After lunch: https://collaboration.fda.gov/p16jfzvl33t/ After afternoon break: https://collaboration.fda.gov/p4q5dpopces/ AGENDA 8:30-9:00 Breakfast 9:00-9:05 Welcome and Introductions Deborah Fisher (Duke), Tony Du (FDA)   9:05-10:20 Stakeholder Perspectives Moderator:  Ben Fisher (FDA) Speakers/Affiliations 9:05-9:15 Use of Real World Evidence in Regulatory Decisions Owen Faris (FDA) 9:15-9:25 Clinically Meaningful Outcomes for Weight Loss Procedures and Devices Marina Kurian (SAGES) 9:25-9:35 Challenges in Generating Evidence for Obesity Therapies Laura Eaton (Apollo) 9:35-9:45 Patient Perspective: Meaningful Weight Loss and Associated Tolerance for…

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September 2016

RAPID Think Tank

September 14, 2016
FDA Headquarters, White Oak Campus, Silver Spring, MD 20993 United States + Google Map

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1st Public Release of the Phase I RAPID Core Data Set for PAD Device Evaluation

Aligning RAPID with National Evaluation System for Health Technology (NEST), Sentinel, HSPC, and other ongoing initiatives

International alignment leveraging RAPID core data elements

RAPID implementation and clinical trial opportunities for Peripheral Devices

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Real World Evidence and Post-market Surveillance Live Webcast

September 20, 2016 @ 16:00 - 17:00
Webcast,

Register Now for this live webinar! Presenter Libbe L Englander, PhD, Founder and CEO of Pharm3r LLC Libbe founded Pharm3r in 2011 to apply programmatic approaches such as natural language processing and web scraping to help evaluate medical products and companies. The stakes for proactive surveillance in analyzing healthcare product performance have never been higher. Doctors, consumers, regulators, and device companies make decisions every day that rely on accurate, fast, and holistic understanding of the risks associated with medical devices.…

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October 2016

2016 MDEpiNet Public-Private Partnership Annual Meeting – Postponed

October 1, 2016
White Oak Campus, FDA Headquarters, 10903 New Hampshire Avenue
Silver Spring, MD United States
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Our 2016 Annual Meeting has been Postponed! Check back later to find the new date.

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November 2016

International Consortium of Vascular Registries Meeting

November 15, 2016 @ 08:00 - 17:00
New York Hilton Midtown, 1335 Ave of the Americas
New York, 10019 United States
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**By Invitation Only** A working meeting of the International Consortium of Vascular Registries (ICVR), bringing together leadership board members, FDA representatives, and industry professionals to discuss ongoing and new vascular data analysis projects within the ICVR collaboration framework.

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February 2017

Ninth Annual Sentinel Initiative Public Workshop

February 2 @ 09:00 - 16:30
Kaiser Family Foundation – Barbara Jordan Conference Center, 1330 G St NW
Washington, DC 20005 United States
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The Food and Drug Administration (FDA) is announcing a public workshop to be held on February 2, 2017, entitled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of the FDA's Sentinel Initiative, an overview…

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March 2017

Establishing the National Evaluation System for Health Technology (NEST) Coordinating Center

March 17 @ 13:00 - 14:00
Webex,

NIH Collaboratory Grand Rounds: Rethinking Clinical Research Speakers Bill Murray CEO & President Medical Device Innovation Consortium (MDIC) Dawn Bardot, PhD Vice President, Technology Innovation Medical Device Innovation Consortium (MDIC) Topic Establishing the National Evaluation System for Health Technology (NEST) Coordinating Center Meeting Information To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online meeting: Go to https://dukemed.webex.com/dukemed/j.php?MTID=m1a4a0665a615ae0382440edecedbdd33 You must log in to the URL first.…

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May 2017

IDEAL Conference 2017

May 4 - May 5
New York Academy of Medicine, 1216 5th Ave
New York, NY 10029 United States
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The IDEAL Collaboration Idea, Development, Exploration, Assessment, Long-term Follow-up, Improving the Quality of Research in Surgery Research, Regulation, and Reimbursement in Surgery and Technologies Learn about the latest developments in the scientific methodology for investigating new surgeries and medical devices Hear internationally renowned surgical researchers discussing innovation and evaluation in multiple clinical areas Present your research on innovations in surgery and therapeutic technology to an international audience of clinicians, scientists, manufacturers and regulators Learn about IDEAL pathways for innovation in…

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Mid-Year Update Webinar – Accomplishments and Opportunities

May 16 @ 14:00 - 17:00

Please join us for this webinar. Register now to learn about MDEpiNet accomplishments and opportunities. Draft Agenda Register Here Agenda 2:00 pm-2:25 pm: Opening Session Welcome and Introduction Opening Remarks 2017 MDEpiNet PPP Update 2:25 pm-2:50 pm: Committees/Centers Update Report from Executive Operations Committee Report from Science and Infrastructure Center Report from Methodology Center Report from Scientific Oversight Committee Report from International Committee 2:50 pm-4:00 pm: MDEpiNet Scientific Portfolio Updates MDEpiNet Scientific Portfolio and Capacity Coordinated Registry Networks PASSION International…

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RAPID Phase II/III Working Group Meeting

May 25
Sheraton Silver Spring, 8777 Georgia Ave.
Silver Spring, 20910 United States
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Registry Assessment of Peripheral Interventional Devices (RAPID) Phase II/III Working Group Meeting  Be Part of the Launch Team! May 25 DRAFT Agenda (updated May 18) RAPID Meeting Logistics Phase I of RAPID, the 100 minimum core data elements for device evaluation of devices in PAD, was delivered ahead of schedule. On May 25, 2017, the Phase II implementation of these data elements into electronic registries and health records will be complemented by the acceleration of Phase III: the first clinical…

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