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Session 1: Global Labeling Issues and Updates: US and Canada
Session Chair(s)
A. Leander Fontaine, MD
President, Pharmiceutics, LLC., United States
This session provides updates on important labeling-related regulatory developments in the US and Canada that are essential for those involved in drafting US and Canadian labeling. The discussion will also explore the importance of these developments for core and worldwide labeling.
Speaker(s)
Dora W Cohen, MSc
Director, Global Labeling, PRA HS, United States
US Proposed E-Labeling Rule
Tamara Johnson, MD, MS
Acting Team Leader, Division of Pediatrics and Maternal Health, OND, CDER , FDA, United States
Pregnancy and Lactation Labeling Rule Updates (US)
Lonnie D. Smith
Policy Analyst, Office of the Chief Scientist, Office of Health Informatics, OC, FDA, United States
Updates on the Use of Structured Product Labeling and the Indexing Initiative
Veronica Yip
Manager, Labelling Division, Health Canada (PDD), Canada
Plain Language Labeling Initiative Regulations in Canada
Michelle Remillard
Senior Policy Analyst, Pharmaceutical Drugs Directorate, Health Canada, Canada
The 2016 Canadian Product Monograph Guidance
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