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Session 3, Track A: Evolution of Labelling
Session Chair(s)
Amber McLeod, PHD
Immunology, Virology, and Specialty Head, Regulatory Affairs, Abbvie Corporation, Canada
Marcia Sam
Senior Manager, Regulatory Affairs, Regeneron Canada Company, Canada
This session will focus on the latest trends and challenges in product labeling, with an emphasis on technological advancements, regulatory compliance, and inclusive communication practices. Attendees will explore the evolving landscape of digital medication information dissemination and gain insights into e-labelling approaches and new risk-based methodology being applied for regulatory compliance. Furthermore, the session will provide insights on adopting gender-inclusive language in labeling to promote equitable and respectful consumer communication. This discussion aims to provide participants with the knowledge and tools needed to effectively navigate and adapt to current and future labeling practices.
- Electronic Patient Medication Information (ePMIs) – Where are We Now?
Neerja Goyal, GlaxoSmithKline, Inc. - Words Matter: Adopting Gender Inclusive Language in Product Labelling
Adesola Adeyemi, BAYER INC. - Pharmaceutical Drug Directorate Paper Package Insert Waiver Assessment Process
Amanda Starr, Health Canada
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the current developments in product labelling as a result of changing technology and regulatory compliance
- Explain how patients and industry will benefit from utilizing technology
- Identify how to incorporate gender-inclusive language into labelling to enhance patient communication
Speaker(s)
Amanda Starr, PHD
Scientific Evaluator - Pharmaceutical Drugs Directorate, Health Canada, Canada
Pharmaceutical Drug Directorate Paper Package Insert Waiver Assessment Process
Neerja Goyal, MS
Director, Regulatory Strategy and Policy, GlaxoSmithKline, Inc., Canada
Electronic Patient Medication Information (ePMIs) – Where are We Now?
Adesola Adeyemi, MSC
Regulatory Affairs Project Manager, Bayer Inc., Canada
Words Matter: Adopting Gender Inclusive Language in Product Labelling
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