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Course Title:
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Life-cycle Planning for Product Safety Evaluation in Support of Benefit-Risk Activities
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Date:
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January 13, 2010 12:00 PM to 1:00 PM EST
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Course Details and Registration
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Course Description:
Day 1: 12:00 PM - 1:00 PM
This webinar will review the need for high quality safety data and explore the general product life-cycle as well as provide an introduction to the Quantitative Safety Analysis Plan (QSAP).
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Course Title:
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Safety Overview and Guidance Documents
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Date:
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January 13, 2010 1:15 PM to 2:15 PM EST
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Course Details and Registration
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Course Description:
Day 1: 1:15 PM - 2:15 PM
This webinar will provide a review of the current paradigm for safety and efficacy and explore a new paradigm for safety in clinical development and an overview of FDA Guidances and EMEA risk management guidelines and generating risk information during clinical trials.
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Course Title:
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Postmarketing Safety Reporting
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Date:
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January 20, 2010 12:00 PM to 1:00 PM EST
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Course Details and Registration
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Course Description:
Day 1: 12:00 PM - 1:00 PM
This webinar will focus on Post-Marketing safety reporting, including adverse events and reporting timelines, best practices, and avoiding pitfalls. Risk management will also be discussed. The presentation will last approximately 1 hour, with ample time for questions and discussion.
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Frequently Asked Questions (FAQ) about Webinars
If you have questions or comments, or need additional information or service please contact us at
Webinar Courses or (703) 276-0178.
We will be happy to assist you.
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