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Global Labeling Conference

Session 1: Updated Global Regulations and Guidances (Including Canada and Australia)

    Session Chair(s)
      Mark A. Collins, PhD, MBA

      Mark A. Collins, PhD, MBA

      • Global Labeling Lead
      • CSL Behring, United States
    This session contains two presentations from Heath Canada representatives providing an abbreviated overview of the updated PM guidance and discussion of any early noteworthy items/issues since the update, and an overview and comparison of the SPL Initiative in Canada to SPL in US and IDMP in Europe. The session also contains a comparison of the PM guidance to the US PI and EU SMPC.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the commonalities and differences between the labeling requirements of Canada and the US and EU
    • Discuss the current SPL Initiative in Canada
      Speaker  Invited

      Speaker Invited

      • Health Canada, Canada
      Mark A. Collins, PhD, MBA

      The Updated Australian Product Information Template

      Mark A. Collins, PhD, MBA

      • Global Labeling Lead
      • CSL Behring, United States
      A. Leander  Fontaine, MD

      A Comparison of the Canada PM Guidance to the US PI and EU SMPC Requirements

      A. Leander Fontaine, MD

      • President
      • Pharmiceutics, LLC., United States
      Luiza  Madeira


      Luiza Madeira

      • Sr. Regulatory Affairs Associate
      • Eli Lilly Canada Inc., Canada

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Preconference Short Course

Writing Good Core Data Sheets and Supporting Documentation

Complimentary Webinar

What is Hot in Global Labeling? | Feb. 20 | 12:00-1:00PM ET