Medical Devices

Regulatory Science and Sustainable Implementation of National and International Medical Device Registries, March 24, 2014


Announcement and Invitation to Attend

Background & Objectives: 

The Medical Device Epidemiology Network (MDEpiNet), a Public Private Partnership of international medical doctors, medical professional societies, academia, and health care systems involved with medical devices registries responsible for the International Consortium of Orthopedic Registries (ICOR) and the new International Consortium of Cardiovascular Registries (ICCR) will be offering a training/think tank program on Monday, March 24, 2014.  

This program will focus on highlighting the regulatory infrastructure and principles that will leverage medical device registries linked with relevant data sources, and harmonized methodological principles (including surveillance, targeted studies, research, and potential application to support premarket applications). The faculty will evaluate the value of integrating the information from disparate data sources (including registries) throughout total product life cycle, highlight issues related to data quality, interoperability and generalizability, illustrate the role of registries in evidence generation for transformative and mature technologies and examine the role of innovative methodologies and registry infrastructure in impacting the speed and quality of medical device innovation.  

Participants and Registration:  Anticipated workshop attendees are medical device regulators from APEC, ASEAN, Latin American and other economies as well as industry representatives.  To register, please register by submitting the following information no later than March 7, 2014.

Submit information by email to: CDRHForum@fda.hhs.gov

  • Full Name (Mr., Mrs., Ms., Dr.)
  • Organization
  • Economy/Country
  • Title
  • Email Address
  • Telephone Number
  • Fax Number
  • Dietary Restrictions (if any)
  • Necessary Accommodations (if any)

Back to Top Arrow


Meeting Location

Parc 55 Wyndham San Francisco-Union Square
* Mission Room
55 Cyril Magnin Street
San Francisco, CA  94102

* Please check the hotel reader boards once you arrive

Back to Top Arrow


Contact Information

Britt Barham, Duke Clinical Research Institute
britt.barham@duke.edu
Phone:  919-668-8120

Princess Grimes, Duke Clinical Research Institute
princess.grimes@dm.duke.edu
Phone:  919-668-8540

Back to Top Arrow


Lodging Information

Like the IMDRF Stakholders Meeting, this MDEpiNet workshop will take place at the Parc 55 Wyndham Hotel, 55 Cyril Magnin Street, San Francisco, California, 94103 (tel:800-595-0507). Please use this link to reserve sleeping rooms in the hotel room block at a special negotiated rate: https://parc55hotel.reztrip.com/special_offer?rate_code=FDA&offer_code=IMDRF&vr=3

U.S. Visa Information: Visa requirements to enter the United States can be obtained on the following U.S. State Department website (travel.state.gov/visa/).

Back to Top Arrow


Agenda

09:00-10:30: Plenary Session
Opening Remarks: Kimberly Trautman
Session Chairs: Sharon-Lise Normand, PhD and Kazuhiro Sase, MD, PhD

  • 09:00-09:15 What Registries Offer Medical Device Evaluation: A Regulatory View (Danica Marinac-Dabic, MD, PhD)
  • 09:15-09:30 Can National & International Registry Infrastructure Really Promote Device Innovation: An Industry View (Jeffrey Secunda, MBA)
  • 09:30-09:45 One Infrastructure Many Objectives: Formative Role for Public-Private Partnerships (Mitchell Krucoff, MD)
  • 09:45-10:30: FACULTY DISCUSSION

10:30-11:00 BREAK

11:00-12:30: Overarching Issues for Medical Device Registries
Session Chairs: Art Sedrakyan, MD, PhD and Ralph Brindis, MD, MPH

  • 11:00-11:15 Linking, Accessing, Governing and Security of Electronic Registries: The Value of Global Essential Principles (Brian McCourt)
  • 11:15-11:30 Methodologies for Device Evaluation Using Integrated Electronic Registries and Tools: Essential Considerations (Sharon-Lise Normand, PhD)
  • 11:30-11:45 Applying Integrated UDI & Registries into the Total Product Life Cycle (Danica Marinac-Dabic, MD, PhD)
  • 11:45-12:30 FACULTY DISCUSSION

12:30-13:30 LUNCH BREAK

13:30-15:00: Focus--Orthopedic Registries
Session Chairs: Kim Trautman and Brian McCourt

  • 13:30-13:50: Case study and subsequent organization and growth of international infrastructure: ICOR (Art Sedrakyan, MD, PhD)
  • 13:50-14:05: Manufacturer perspectives: addressing the challenge in orthopedics (Blair Fraser)
  • 14:05- 14:20: Regulators perspective: FDA Vision for innovative surveillance of orthopedic implants (Danica Marinac-Dabic, MD, PhD)
  • 14:20-15:00: FACULTY DISCUSSION

15:00-15:30 BREAK

15:30-17:00: Focus--Cardiovascular Registries
Session Chairs: Mitchell Krucoff and Meguru Watanabe

  • 15:30-15:45: TAVR: case study on the value of collaboration (Ralph Brindis, MD, MPH)
  • 15:45-16:00: Linking procedural and payment databases: a model for combined short and long term clinical trials & safety surveillance (Matthew Brennan, MD, MPH)
  • 16:00-16:15: INTERMACS-JMACS: A model of international and inter-agency registries (Kazuhiro Sase, MD, PhD)
  • 16:15-17:00: FACULTY DISCUSSION

17:00-17:15: Summary Comments & Possible Next Steps


FACULTY DISCUSSANTS

Regulators:

  • Kimberly Trautman (FDA)
  • Danica Marinac-Dabic, MD, PhD (FDA)
  • Raymond Chua, MSc, MBA (HSA)
  • Meguru Watanabe, MD (PMDA)

Academics:

  • Sharon-Lise Normand, PhD (Harvard)
  • Art Sedrakyan, MD, PhD (Cornell)
  • Ralph Brindis, MD, MPH (ACC)
  • Matthew Brennan, MD, MPH (Duke)
  • Mitchell Krucoff, MD (Duke)
  • Brian McCourt (Duke)
  • Kazuhiro Sase, MD, PhD (Juntendo University)

Industry:

  • Jeffrey Secunda, MBA (AdvaMed)
  • Sandeep Brar, MD (Medtronic)
  • Jodi Akin (Consultant, MedTech)
  • Azin Parhizgar, PhD (Claret Medical)
  • Roseann White, MA (Abbott Vascular)
  • Gary Thompson (Abbott Vascular)
  • Kenneth Stein, MD (Boston Scientific)
  • Srijoy Mahapatra, MD (St. Jude)
  • Neal Fearnot, PhD (Cook Group)
  • Larry Wood (Edwards Lifesciences)
  • Blair Fraser (Smith & Nephew)

Back to Top Arrow


IMDRF STAKEHOLDER MEETING, MARCH 26, 2014

Separate registration required to attend. 

Register at: International Medical Device Regulators Forum (IMDRF) - Stakeholders Meeting, March 26, 2014

Back to Top Arrow


Additional Training Opportunity - March 27 -28, 2014

March 27-28, 2014 -- Regulatory Capacity Building: The U.S. Department of Commerce and U.S. FDA invite global medical device regulators to participate in a two-day regulatory capacity building training program in collaboration with the World Health Organization (WHO) to take place on the margins of the International Medical Devices Regulator Forum (IMDRF) stakeholders forum.  Space for workshop participation is limited, so medical devices regulators are encouraged to register through the below e-mail addresses as soon as possible.  The workshop’s objectives are to share information of medical devices regulation based upon the Global Harmonization Task Force (GHTF) global model and in sharing information on the U.S. medical device regulatory system, including basic and advanced topics such U.S. registration and listing, device approvals/clearances, as well as Supply Chain Controls, Unique Device Identifiers (UDI), Software review practices and Combination Products.

Back to Top Arrow

Page Last Updated: 07/11/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.