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Activity Number:
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131
- Topics in Clinical Trials
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Type:
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Contributed
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Date/Time:
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Monday, July 29, 2019 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #301837
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Presentation 1
Presentation 2
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Title:
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Challenges of Filing Externally Conducted Clinical Trials
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Author(s):
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Kenneth Liu* and Jonathan Hartzel
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Companies:
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Merck & Co., Inc and Merck & Co., Inc
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Keywords:
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SDTM;
Collaboration
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Abstract:
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Many clinical studies are performed by non-pharmaceutical organizations. When these externally conducted clinical trial are included in a regulatory filing submission, challenges can arise.
This presentation will discuss many examples of challenges that can arise when externally conducted clinical trial are used in a regulatory filing in the context of an Ebola vaccine.
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Authors who are presenting talks have a * after their name.
