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

• Training Announcement and Invitation to Attend
• Registration
• Meeting Location
• Contact Information
• Lodging Information
• Draft Agenda
• IMDRF Stakeholder Meeting (Registration Information)
• Additional Training Opportunity

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.

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

09:00-10:30:  Plenary Session
Session Chairs:  Sharon-Lise Normand and Nobua Uemura

• 09:00-09:15 What Registries Offer Medical Device Evaluation:  A Regulatory View (Danica Marinac-Dabic)
• 09:15-09:30 Can National International Registry Infrastructure Really Promote Device Innovation:  An Industry View (TBA)
• 09:30-09:45 One Infrastructure Many Objectives:  Formative Role for Public-Private Partnerships (Mitch Krucoff)
• 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 and Ralph Brindis

• 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)
• 11:30-11:45 Applying Integrated UDI Registries into the Total Product Life Cycle  (Danica Marinac Dabic)
• 11:45-12:30  FACULTY DISCUSSION

12:30-13:30  LUNCH BREAK (Lunch will be provided on-site, at no charge)

13:30-15:00:  Focus–Orthopedic Registries
Session Chairs:  Danica Marinac Dabic and  Art Sedrakyan

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

15:00-15:30   BREAK

15:30-17:00:  Focus–Cardiovascular Registries
Session Chairs:  Mitchell Krucoff and Madoka Murakami

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

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

INVITED FACULTY DISCUSSANTS

Regulators:

• Kim Trautman (FDA)
• Danica Marinac Dabic (FDA)
• John Lim (HSA)
• Christina Lim (HSA)
• Madoka Murakami (PMDA)
• Nobuo Uemura (PMDA)
• Mami Ho (PMDA)

Academics:

• Sharon Lise Normand (Harvard)
• Art Sedrakyan (Cornell)
• Ralph Brindis (ACC)
• Matt Brennan (Duke)
• Mitch Krucoff (Duke)
• Brian McCourt (Duke)
• Fred Resnick (Harvard)
• Kazuhiro Sase (Juntendo University)

Industry:

• Jeff Secunda (AdvaMed)
• Rick Kuntz (Medtronic)
• Bill Hawkins (Immucor)
• Michael Gropp (Medtronic)
• Sandeep Brar (Medtronic)
• Jodi Akin (Edwards)
• Azin Parhizgar  (Claret Medical)
• Gary Johnson (Abbot Vascular)
• Roseann White (Abbott Vascular)
• Gary Thompson (Abbott Vascular)
• Keith Dawkins (Boston Scientific)
• Ken Stein (Boston Scientific)
• Peter Lam (Boston Scientific)
• Srijoy Mahapatra (St. Jude)
• Mark Carlson (St. Jude)
• Pam Plouher (JJ)
• Tara Federici, AdvaMed

Separate registration required to attend. 

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