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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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May 15, 2010 |
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Drug Information Association, Inc. , Horsham, PA
Nov 15 2010 8:00AM - Nov 16 2010 4:00PM
Fundamental Concepts of Clinical Safety
Learn how to comply with FDA and European regulations for clinical safety. What you will learn
• Fundamental concepts of drug safety and Pharmacovigilance and their application to clinical development
• How to comply with FDA and European regulations for clinical safety
• How to pass a preapproval safety inspection
• Proven concepts of premarketing risk assessment and its important role in the development of Risk Evaluation and Mitigation Strategies (REMS)
• How to effectively use signaling tools and techniques to support premarketing risk assessment
Learning Objectives:
At the conclusion of this course, participants should be able to:
• Discuss why premarketing clinical safety and Pharmacovigilance is important to ensure Good Pharmacovigilance Practice
• Explain the requirements of FDA and European regulation for premarketing clinical safety and Pharmacovigilance
• Prepare for a preapproval inspection for clinical safety
• Develop company policies and procedures for clinical safety
• Perform a premarketing risk assessment
Target Audience:
Professionals involved in:
• Clinical safety and Pharmacovigilance
• Clinical development
• Regulatory affairs
• Quality management
Event Code:
10438
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Organized by:
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Drug Information Association, Inc. |
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Invited Speakers:
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Call contact
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Deadline for Abstracts:
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Call contact
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Registration:
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For detailed program information including faculty and topics, please contact:
Laura Parker
Tel. +1-215-442-6101
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E-mail:
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Laura.Parker@diahome.org
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