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Consulting - Training - Labeling Services
Regulatory Support - Research - Auditing
Assisting pharmaceutical companies and other organizations in evaluating, developing, implementing and managing:
- Healthcare professional information
- Patient / consumer information
- Labeling systems, processes, organizations and technology
Providing expertise in:
- US and EU labeling (content, regulatory aspects, format)
- Designing and implementing core labeling (incl. Development Core Safety Information)
- Designing effective and defensible safety labeling
- Managing complex labeling and regulatory situations - whether local or global
- Designing efficient and defensible regulatory / labeling processes, organizations and systems
Supporting regulatory/labeling, pharmacovigilance, medical, clinical, marketing and law departments
Copyright 2005-2008 Pharmiceutics LLC
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SAFETY LABELING -
IN-DEPTH REVIEW OF IMPORTANT ASPECTS
Asking the right questions - Finding effective solutions
Early Fall 2009
Philadelphia
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US PRESCRIBING INFORMATION WITH HIGHLIGHTS & US SAFETY LABELING
Understanding - Writing - Reformatting Safety and Other Sections
Summer 2009 (tentative)
Philadelphia
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GLOBAL LABELING PROCESS DESIGN AND EVALUATION
Good Labeling Process Practices - Evaluation - Solutions
Summer 2009 (tentative)
Philadelphia
Click for details |
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Copyright © 2005-2008 Pharmiceutics LLC. All rights reserved.
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