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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)
US Proposed E-Labeling Rule
Dora W Cohen, MSc
PRA HS, United States
Director, Global Labeling
Pregnancy and Lactation Labeling Rule Updates (US)
Tamara Johnson, MD, MS
FDA, United States
Acting Team Leader, Division of Pediatrics and Maternal Health, OND, CDER
Updates on the Use of Structured Product Labeling and the Indexing Initiative
Lonnie D. Smith
FDA, United States
Policy Analyst, Office of the Chief Scientist, Office of Health Informatics, OC
Plain Language Labeling Initiative Regulations in Canada
Veronica Yip
Health Canada (TPD), Canada
Acting Manager, Labelling Division
The 2016 Canadian Product Monograph Guidance
Michelle Remillard
Health Canada, Canada
Senior Policy Analyst, Pharmaceutical Drugs Directorate