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June 2016

MDEpiNet Think Tank I: Active Surveillance

June 1, 2016 @ 08:00 - 17:00
White Oak Campus, FDA Headquarters, 10903 New Hampshire Avenue
Silver Spring, MD United States
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June 1, 2016 Capitalizing on the National/International Infrastructure to Develop Methods for 21 Century Active Surveillance Agenda Event Recordings https://collaboration.fda.gov/p7t3jsjptli/ https://collaboration.fda.gov/p73krg6ro4z/ https://collaboration.fda.gov/p72v8nuho3d/ https://collaboration.fda.gov/p59zzmfglv9/ 8:00-8:15 Opening Remarks Program Leaders: Sharon-Lise Normand, Harvard Frederic Resnic, Lahey Danica Marinac-Dabic, FDA 8:15-9:30 Plenary Session: Harnessing Real World Evidence for Active Surveillance: Moderators: Kathleen Hewitt, ACC and Ben Moscovitch, Pew Electronic Patient Data Linkage to EHR– Harlan Krumholz, Yale (30 min) Legal Environment– Robert Portman, Powers, Pyles, Sutter & Verville (30 min) Audience Questions (15 min)…

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CDISC Webinar: Kit Howard & Michael Ibara

June 16, 2016 @ 14:30 - 16:00

Play the recording Webinar Link Speaker Presentations Kit Howard: What is CDISC? Introduce CDISC and its clinical standards Where do CDISC standards fit into the larger picture of standards Opportunities to leverage CDISC in MDEpiNetprojects Michael Ibara: CDISC HCL and eSource Describe CDISC’s eSource initiative Introduce topic area challenges and opportunities  

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Building the National Evaluation System for Medical Devices: making a case for a return on investment (ROI) for use of Real-World Evidence

June 17, 2016 @ 08:15 - 17:00
White Oak Campus, FDA Headquarters, 10903 New Hampshire Avenue
Silver Spring, MD United States

Recording links https://collaboration.fda.gov/p6811gb4p7c/ https://collaboration.fda.gov/p1c7m75jpvj/ https://collaboration.fda.gov/p879zktkkhd/ https://collaboration.fda.gov/p1l2n1g58v6/ Agenda 08:15-08:30        Opening Remarks:  Objective of meeting and logistics – Jesse Berlin Demonstration that NES will create a platform for better, faster and cheaper studies and data for regulatory decision making 08:30-10:15        Session 1:  Where are we? Moderator:  Provide overview regarding need for this meeting as it developed out of value proposition work – Danica Marinac-Dabic Creating Value: Criteria and Considerations for the Development of a Sustainable National System? – Heather Colvin (10 Minutes)…

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July 2016

FDA Webinar – An Update on the Medical Device Clinical Trials Program

July 14, 2016 @ 14:00 - 15:30

July 14, 2016, from 2:00 – 3:30 PM (Eastern Time). To ensure you are connected, log-in by 1:45 PM. Join the FDA for an update on two key activities from the CDRH Office of Device Evaluation Clinical Trials Program: Early Feasibility Studies Draft Guidance:  FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicaid Services (CMS) with Coverage Decisions Webinar Details Registration is not necessary; however we expect high interest in the event and recommend you connect…

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GI Coordinated Registry Network: A Case for Obesity Devices

July 29, 2016
FDA Headquarters + Google Map

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

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. span.tribe-event-date-start {display: none;}.tribe-events-meta-group.tribe-events-meta-group-details dl {display: none;}

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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, 2017 @ 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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