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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 reviews recent updates to global regulations and guidances and the update on the Structured Product Monograph (SPM) initiative in Canada. A representative from Health Canada has been invited and the session also contains an industry viewpoint.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the recent changes to the Australian Product Information Template
    • Describe the criteria for adding adverse reactions to the labeling in the major markets and to reference safety information (RSI) in clinical trial applications in the EU
    • Discuss the current SPM Initiative in Canada
    Speaker(s)
      Mark A. Collins, PhD, MBA

      Recent Changes to the Product Information Requirements in Australia and New Zealand

      Mark A. Collins, PhD, MBA

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

      Adverse Reactions in Regional Labeling and Investigator Brochures: Inconsistent Expectations

      A. Leander Fontaine, MD

      • President
      • Pharmiceutics, LLC., United States
      Craig  Anderson

      The Canadian Structured Product Monograph (SPM) Initiative

      Craig Anderson

      • Business Analyst
      • Health Canada, Canada
      Luiza  Madeira

      The Canadian Structured Product Monograph (SPM) Initiative from an Industry Perspective

      Luiza Madeira

      • Consultant, Global Labeling Department
      • Eli Lilly Canada Inc., Canada