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March 2018

Patient Engagement and NEST: Lessons Learned and Best Practices

March 22, 2018
University of Maryland, School of Pharmacy, 20 N. Pine Street
Baltimore, MD 21201 United States
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Program Chairs: Fadia T. Shaya, PhD, MPH and Frank B. Palumbo, PhD, JD University of Maryland Baltimore Center on Drugs and Public Policy, School of Pharmacy, Pharmaceutical Health Services Department Gregory Pappas, MD, PhD, and Lisa Miller, PhD Center for Devices and Radiological Health (CDRH) Food and Drug Administration   Meeting Objectives:  This meeting will engage a variety of patient and patient groups related to the device ecosystem.  An objective of NEST is to fully engage patients in its development and…

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May 2018

Registry Assessment of Peripheral Interventional Devices (RAPID) Working Group Meeting

May 2, 2018 @ 07:00 - 16:00
FDA Headquarters, White Oak Campus Silver Spring, MD 20993 United States + Google Map

Walk-in registrations are welcome day of the meeting. Event Agenda Register here Please click the links below to review select presentations from the meeting: RAPID SPEED: An Overview Jack Cronenwett, Dartmouth-Hitchcock / Society for Vascular Surgery Objectives of the Day Pablo Morales, US Food and Drug Administration Statistical Analysis Plan Roseann White, Duke Clinical Research Institute The SPEED OPG Results: First Public Look Daniel Bertges, University of Vermont medical Center/Society for Vascular Surgery RAPID SPEED Cost and Value to Industry:…

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SPARED Meeting

May 3, 2018 @ 08:00 - 16:00
FDA Headquarters Silver Spring, MD United States + Google Map

Recordings from the SPARED meeting: Part 1: https://collaboration.fda.gov/p3049phvogl/ Part 2: https://collaboration.fda.gov/p4x8ngz5yuz/ Part 3: https://collaboration.fda.gov/p5uk6h46sc2/ Part 4: https://collaboration.fda.gov/p7zhawdfvy3/   Presentations from the SPARED meeting: Art Sedrakyan - Why do we need a Community of Practice and What it Should Do Danica Marinac-Dabic - IMDRF Registry Working Group Larry Kessler - Magforce USA - Fighting Cancer with Nanotherm Therapy Roland Velthoven - To Develop and Regulate Modern PCa-Care Tulsa-Pro - Prostate Ablation James Wysock - SPARED Data Collection Charles Viviano - SPARED…

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TMJ Meeting

May 11, 2018 @ 08:00 - 17:00
FDA Headquarters Silver Spring, MD United States + Google Map

2018 TMJ Patient Led Meeting Agenda 2018 TMJ Meeting Logistics

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IC3 Meeting

May 19, 2018
Nashville, TN Nashville, TN United States + Google Map

RSVP here Itinerary TBA  

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ICVR Meeting

May 30, 2018 - May 31, 2018
Iceland Iceland + Google Map

RSVP here Itinerary TBA

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DAISI Meeting

May 31, 2018
FDA Headquarters Silver Spring, MD United States + Google Map

Agenda  

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July 2018

Studies for Prostate Ablation Related Energy Devices (SPARED) CRN Think Tank Meeting

July 10, 2018
FDA Headquarters, White Oak Campus Silver Spring, MD 20993 United States + Google Map

SPARED July 10 meeting notes FDA Meeting Transcript 7_10_18

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September 2018

Women’s Health Technologies CRN Meeting

September 7, 2018
FDA Headquarters Silver Spring, MD United States + Google Map

Agenda    September 7, 2018 WHT CRN Meeting Recording: Part 1: https://collaboration.fda.gov/p8s6y7dasz8/ Part 2: https://collaboration.fda.gov/p9kwl39zbpg/ Part 3: https://collaboration.fda.gov/p3j9ddv0upe/   September 7, 2018 WHT CRN Meeting Presentations: 0845-0925 A Advancing Capacity for Women's Health (Danica Marinac-Dabic) 0845-0925 B CDRH Health of Women CRN (Terri Cornelison) 0845-0925 C National Evaluation System for Health Technologies NEST Update (Rachael Fleurence)  0925-0930 Overview of WHT CRN Work Streams (Courtney Baird) 0930-0950 Sterilization/LARC (Scott Chudnoff) 0950-1010 Pelvic Organ Prolapse (Cate Bradley & Kathleen Kobashi) 1010-1030 Uterine…

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VISION Meeting

September 10, 2018
FDA Headquarters Silver Spring, MD United States + Google Map

VISION Meeting Agenda   September 10, 2018 VISION Meeting Presentations: Introduction (Phil Goodney) Introduction (Art Sedrakyan) Development of CRNs: Benefits to the FDA Mission (Danica Marinac-Dabic) Registry Partners Incentive's and Roles (Jens Eldrup-Jorgensen) RAPID/SPEED: Development, accomplishments, and how they might integrate further with VISION (Yu-Ching Tcheng) RAPID/SPEED: Development, accomplishments, and how they might integrate further with VISION(Daniel Bertges) EDUCATE: (NESTcc Demonstration Project): Goals, potential impact, and mechanisms for development of CRN-derived datasets (Kathy Blake) EDUCATE: (NESTcc Demonstration Project): Goals, potential…

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