QUESTIONSUS and International Prescription Drug Labeling Comparisons and Important Updates
Venue: Washington
Location: Washington, Washington DC, United States
| Event Date/Time: Dec 08, 2010 | End Date/Time: Dec 09, 2010 |
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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
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
