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Opening Remarks and Plenary Session
Session Chair(s)
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
The world around us is quickly changing. Emerging technologies are dramatically altering the health landscape, while health products are becoming ever more complex and personalized. This keynote will kick off the DIA Canada Annual Conference by discussing Health Canada’s role as regulator in the face of the evolving health and biosciences ecosystem. Elizabeth Toller will speak to the key change drivers behind this evolution, the need for greater regulatory agility in response, and the implications of the COVID-19 pandemic.
The keynote address will be followed by a presentation on innovative global regulatory strategies using a case study that will provide practical regulatory recommendations on how to speed up drug development and reduce drug development costs while meeting high quality drug approval standards set by Health Authorities. A blueprint for product development with appropriate regulatory interactions will be shared followed by a discussion of regulatory incentives and pathways that may be leveraged for product development.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the key drivers of change in the health and biosciences sector requiring greater regulatory agility, and the impacts of COVID-19 on these change drivers
- Identify major obstacles in drug development and learn how to productively engage with Health Authorities (Health Canada, EMA and FDA) during global drug development to bring drugs to the market in an efficient manner
Speaker(s)
Speaker
Elizabeth Toller, MA
Health Canada, Canada
Associate Director General, Policy, Planning and International Affairs Directora
Speaker
Oxana Iliach, PhD
Certara, Canada
Senior Director Regulatory Strategy
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