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Virtual Event

Oct 19, 2020 9:55 AM - Oct 20, 2020 5:30 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA Annual Canadian Meeting

Session 7 Track B: The Regulatory Review of Drugs and Devices (R2D2) Project Wrap-up

Session Chair(s)

Melissa  Hunt, MSc

Melissa Hunt, MSc

Director

Health Canada, Canada

The Regulatory Review of Drugs and Devices is an initiative that aims to build an agile regulatory system supporting better access to therapeutic products based on healthcare system needs. This initiative consisted of 15 individual projects. Since its beginning in 2017 there have been many successes. This session will give a general update of the initiative as it enters its final stages, as well as dive deeper into 4 of the projects (transparency, early parallel scientific advice, expansion of Priority Review pathways, and the Special Access Programme renewal). Many of the other projects and their progress will also be discussed in other session throughout the meeting.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Explain what the R2D2 initiative was and the progress it has made
  • Discuss the current and future state of transparency initiatives, early parallel scientific advice and the Special Access Programme
  • State the next steps for the expansion of Priority Review pathways project

Speaker(s)

Megan  Bettle, PhD

Year Three Status - Regulatory Review of Drugs and Devices

Megan Bettle, PhD

Health Canada, Canada

David  Southam, PhD

Accelerated Review of Human Drug Submissions: An Update

David Southam, PhD

Health Canada, Canada

Senior Clinical Evaluator

Carole  Legare, MD

Special Access Programme Renewal

Carole Legare, MD

Health Canada, Canada

Director, Office of Clinical Trials, TPD

Neerja  Goyal, MS

Speaker

Neerja Goyal, MS

GlaxoSmithKline, Inc., Canada

Director, Regulatory Strategy and Policy

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