International Medical Device Regulators Forum (IMDRF), September 15-19, 2014

A week of global meetings to discuss worldwide medical device regulation and harmonization efforts.

All interested parties are invited to attend many of the events throughout the week (some events are closed to invited members/regulators only). See below a full list of meetings, including a brief description of the event and the participation allowance. The events are centered around the mid-week plenary session of the IMDRF Stakeholders Meeting. During this meeting, participants will be invited to discuss continuous improvements to device safety and performance, and emerging challenges in medical device regulation. Stakeholder input is important to global harmonization, and the IMDRF Management Committee greatly appreciates your participation and contribution.

PLEASE NOTE: There is no fee to register for any of the events/meeting throughout the week. You must register for ALL events you wish to attend. Some events will be open ONLY to invited members and regulators, please only select those events if you received personal invitation. Attendees are responsible for all travel and lodging arrangements and all associated costs. All presentations will be given in English and translation will not be provided. Registration will be limited by space restrictions. Webcast will NOT be available.

• Date, Time and Location
• Lodging Information
• Events and Meetings
• Registration
• Contact Us

This week-long meeting event will be held at the Embassy Row Hotel in Washington, DC, on September 15-19, 2014. Individual meeting times will vary each day. All meetings will be held in the Embassy Row Hotel, specific meeting rooms will be posted inside the hotel. Only in-person attendance is available, meetings will not be webcast.

Meeting Location:
Embassy Row Hotel
2015 Massachusetts Avenue NW
Washington, DC 20036

Embassy Row Hotel
2015 Massachusetts Avenue NW
Washington, DC 20036
Phone: 202-265-1600
Direct Reservation Toll-Free Phone:1-855-893-1011
Room Rate: $219.00 USD per room, per night
Name of Room Block: International Medical Device Regulators Forum – FDA Host

Monday, September 15, 2014:

DITTA International Standards: The Value and Mechanics of Medical Device Standards in the 21st Century — [OPEN TO ALL REGISTRANTS]
Description:  A seminar to discuss the standards “lifecycle” from idea to implementation, including best practices, the future of international standards, and their impact on patient safety and innovation.

• 8:30 a.m. – 5:00 p.m.
• Lunch not provided
• Agenda managed by DITTA, the global organization for the medical imaging, IT and radiation therapy industry

Pan American Health Organization (PAHO) Regulators Meeting: (Day 1) — [OPEN ONLY TO INVITED REGULATORS]
Description: Regional Regulators Closed Discussion

• 1:00 p.m. – 5:00 p.m.
• Lunch not provided
• Agenda managed by PAHO

Tuesday, September 16, 2014:

IMDRF Management Committee (MC) Meeting (Day 1) — [OPEN ONLY TO MC MEMBERS]
Description:  IMDRF MC members will hold a closed meeting to discuss current work items.

• 8:30 a.m. – 12:00 p.m.
• Lunch for purchase (bag lunch available in meeting room)
• Agenda managed by US Food and Drug Administration (FDA)

IMDRF Management Committee (MC) Meeting, with Invited Observers (Day 1 – PM) — [OPEN ONLY TO MC MEMBERS and INVITED OBSERVERS]
Description: IMDRF MC members will host a meeting with invited guests to discuss current issues and work items.

• 1:00 p.m. – 5:00 p.m.
• Agenda managed by US FDA

PAHO Device Regulators Meeting (Day 2) — [OPEN ONLY TO INVITED REGULATORS]
Description: Regional Regulators Closed Discussion

• 8:30 a.m. – 12:00 p.m.
• Lunch not provided
• Agenda managed by PAHO

FDA Information Session (topics TBD) – [OPEN TO ALL REGISTRANTS]
Description: FDA leaders and regulatory experts will discuss topical issues in global medical device regulation, providing the FDA perspective and facilitating a group discussion.

• 1:00 p.m. – 5:00 p.m.
• Agenda managed by US FDA

Wednesday, September 17, 2014:

IMDRF Stakeholders Meeting – [OPEN TO ALL REGISTRANTS]
Description: IMDRF MC members will present on current working group progress and all stakeholders will be invited to provide feedback and discuss ideas for continuous improvements to medical device safety and performance.

• 8:30 a.m. – 5:00 p.m.
• LUNCH – Complimentary lunch for all participants, provided by DITTA (12:00-1:00)
• Afternoon Breakout Sessions – attendees will rotate through all sessions (Topics TBD)
• RECEPTION – Complimentary rooftop reception for all participants, provided by AdvaMed (6:00-8:00)

Thursday, September 18, 2014:

Global Harmonization Summit (Day 1) – [OPEN TO ALL REGISTRANTS]
Description: Representatives from regional regulatory harmonization organizations from around the world will discuss current and future regulatory harmonization activities to further worldwide patient access to safe and effective medical technology.

• 8:30 a.m. – 5:00 p.m.
• Complimentary Lunch provided by AdvaMed
• Agenda managed by AdvaMed

IMDRF Management Committee Meeting (Day 2) – [OPEN ONLY TO MC MEMBERS]
Description:  IMDRF MC members will hold a closed meeting to discuss current issues and future work items.

• 8:30 a.m. – 5:00 p.m.
• Lunch for purchase (bag lunch available in meeting room)
• Agenda managed by US FDA

Friday, September 19, 2014:

Global Harmonization Summit (Day 2) – [OPEN TO ALL REGISTRANTS]
Description: Representatives from regional regulatory harmonization organizations from around the world will discuss current and future regulatory harmonization activities to further worldwide patient access to safe and effective medical technology.

• 8:30 a.m. – 12:00 p.m.
• Lunch not provided
• Agenda developed and managed by AdvaMed

Harmonization by Doing (HBD) West Think Tank Open Meeting – [OPEN TO ALL REGISTRANTS]
Description: HBD is a cooperative effort between Japan and US of academia-industry-government collaboration, prompted by Duke University. This meeting is to discuss the progress of ongoing activities and future direction.

• 1:00 p.m. – 5:00 p.m.
• Agenda managed by HBD

There is no fee to register for these events.  Registration is on a first come first serve basis.  Due to limited seating, please register ONLY for those events you will attend.