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Session 1: Updated Global Regulations and Guidances (Including Canada and Australia)
Session Chair(s)
Mark Collins, PhD, MBA
Principal Consultant
Opus Regulatory, 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)
Recent Changes to the Product Information Requirements in Australia and New Zealand
Mark Collins, PhD, MBA
Opus Regulatory, United States
Principal Consultant
Adverse Reactions in Regional Labeling and Investigator Brochures: Inconsistent Expectations
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
The Canadian Structured Product Monograph (SPM) Initiative
Craig Anderson
Pfizer Inc , Canada
Director, R&D Labeling Lead, International Labeling
The Canadian Structured Product Monograph (SPM) Initiative from an Industry Perspective
Luiza Madeira
Eli Lilly Canada Inc., Canada
Consultant, Global Labeling Department