Product/Service
US And International Prescription Drug Labeling: Comparisons And Important Updates
•Event Brochure: US And International Prescription Drug Labeling: Comparisons And Important Updates
Date(s) And Time(s):
Dec 7 2010 7:30AM - Dec 9 2010 5:00PM
Location:
Embassy Suites DC Convention Center Hotel
900 10th Street, NW
Washington, DC 20001
Interest Area(s):
Clinical Safety/Pharmacovigilance,Regulatory Affairs,Clinical Research
Overview:
Join Regulatory Authorities from Different Regions to Discuss Key Labeling Requirements, Recommendations, Trends, and New Developments.
This conference will discuss issues commonly encountered by industry in an effort to advance understanding of labeling requirements across various regions (Canada, European Union, Japan, and US).
Preconference Workshop— December 7, 2010
(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, 2010
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
- Comparative Review of the Content of the Adverse Reactions Section
- Comparative Review of the Content if the Warnings and Precautions, Contraindications and Boxed Warnings Sections
- Comparative Review of the Content of the Interactions
- Comparative Review of Approaches to Patient Information: Canada, European Union, Japan, and US
- Hot Topics - Important Labeling News and Developments: Canada, European Union, Japan, and US
Learning Objectives:
At the conclusion of this conference, participants should be able to:
- Discuss labeling requirements and their differences in Canada, EU, Japan, and US
- Explain how adverse reactions are selected for inclusion in labeling in Canada, EU, Japan, and US
- Describe new developments in labeling in Canada, EU, Japan, and US
- Outline how regulatory information on medicinal products is made available for health care professionals and patients labeling in Canada, EU, Japan, and US
Target Audience:
Professionals from biopharmaceutical companies, CROs, consulting agencies, and regulatory authorities involved in:
- Labeling
- Clinical safety/Pharmacoepidemiology/Pharmacovigilance
- Regulatory affairs/Drug Review and Approval Process
- Medical affairs/Clinical research & development
- Product research & development alliances
- Quality control/Quality assurance
•Event Brochure: US And International Prescription Drug Labeling: Comparisons And Important Updates
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