Monitor website for venue info, Washington DC
Dec 8 2010 8:00AM - Dec 9 2010 5:00PM
Join Regulatory Authorities from Different Regions to Discuss Key Labeling Requirements, Recommendations, Trends, and New Developments. PRECONFERENCE WORKSHOP — December 7 (Separate registration is required) HIGHLIGHTS • Review of the EU PIM System (Product Information Management System) from a Practical Regulatory Perspective • Structured Product Labeling and eList • US Prescribing Information – Writing the Highlights Section • US Prescribing Information – Writing the Boxed Warning, Contraindications, Warnings and Precautions and Adverse Reactions sections MAIN CONFERENCE — December 8-9 SESSION TOPICS • High Level Comparison of the Approaches to Prescription Drug Labeling: Canada, European Union, Japan, and US • Comparative Review of the Content of the Indications and Clinical Studies Section: Canada, European Union, Japan, and US • Comparative Review of the Rules for Placing Information in Boxed Warnings, Contradictions, Warnings and Precautions and Adverse Reactions Sections and Boxed Warnings: Canada, European Union, Japan, and US • Comparative Review of Content and Format of the Interactions Sections: Canada, European Union, Japan, and US • US Labeling: Overview and Rules for Placing Information in the Highlights Section • Comparative Review of Approaches to Patient Information: Canada, European Union, Japan, and US • Important Labeling News and Developments: Canada, European Union, Japan, and US Event Code: 10022
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