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Regulated Products Working Group - Table of Contents Work Stream Open Stakeholder Meeting September 2015 Nancy Shadeed Health Canada Update Consulted on a Draft Assembly and Technical Guide to support the IMDRF pilot Consulted on

Regulated Products Working Group - Table of Contents Work Stream Open Stakeholder Meeting September 2015 Nancy Shadeed Health Canada
Update • Consulted on a Draft Assembly and Technical Guide to support the IMDRF pilot • Consulted on an IMDRF ToC folder structure (templates) • Updated the IMDRF ToC Pilot Plan • An Expression of Interest Letter was posted 2
Pilot Plan • Australia, Brazil, Canada, China, EU and United States will be participating in the IMDRF ToC • Regional pilots are also currently being undertaken by some IMDRF members. 3
Proposed Timelines Initiation of pilot Sep 2015 Close of pilot (minimum of 12 Sep 2016 months duration) 4
Assembly and Technical Guide • This document is intended to supplement the IMDRF ToC Pilot Plan and describe additional harmonized guidelines for the acceptable folder structure and file format(s) for ToC-based submissions. • Pubic comment period closed June 1, 2015 • 44 comments were received to the Assembly and technical guide and folder structure consultation • File folder naming convention and Folder structure being the most common concerns 5
IMDRF TOC Update • Request for Expressions of Interest and updated Pilot Plan was posted on 21 st of July 2015 • There are now 26 expressions of interest, currently 4 potential multi-jurisdictional. 6
Progress • Assembly and technical guide updated based on comments received • Update to the TOC structure to address concerns raised • Feedback template for industry and regulators developed • Estimated completion early September 2015 7
Next Steps • Feedback to Stakeholders on Consultation comments • Provide updated Assembly and Technical guide and folder structure to Stakeholders who have expressed interest in participation in the pilot by mid Sept 2015 • Convene a stakeholder teleconference by end of September 2015. 8
Thank you 9

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