戻る Agenda
Session 1: Whatever Happened to the Regulatory Review of Drugs and Devices (R2D2) – 2017-2021?
Session Chair(s)
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
In 2017, Health Canada undertook an initiative, commonly referred to as the ‘Regulatory Review of Drugs and Devices’, or ‘R2D2’, to improve the efficiency of Canada’s regulatory system and to provide more timely access to therapeutic products that are aligned with healthcare system needs. In this session, we will provide an overview looking back at the original objectives of R2D2 and the outputs and successes that have been achieved to date of the projects under this initiative. This session will also focus on how the R2D2 has transformed since its inception and how it has helped influence Health Canada’s current regulatory modernization plans.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe what R2D2 was intended to achieve
- Identify the R2D2 initiatives and their status and the progress achieved
- Describe how these initiatives have led to Health Canada’s Regulatory Modernization Framework
Speaker(s)
The Evolution of Regulatory Review of Drugs and Devices (R2D2)
Celia Lourenco, PhD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB