This specialized quiz for Day 2 focuses on the regulatory requirements of bioequivalence studies in Europe, specifically for Zhejiang Anser Medical Technology Co., Ltd. It assesses understanding of critical guidelines, documents, and definitions essential for compliance in pharmaceutical and medical fields.
True
False
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Critical
Major
Minor
All of the above
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File names, including the extension, must not exceed 64 characters.
Folder names must not exceed 64 characters and the total file folder path length must not exceed 180 characters.
Files should be legible with Acrobat Reader, version 5.0 or higher
All of the above
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True
False
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Fast condition
Fed condition
Fast, Fed and Steady State
Fast and Fed
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Clinical expert declaration
Information relating to clinical trials
Quality expert declaration
Similarity declaration
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True
False
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Optional
Fundamental
Situational
All of the above
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Use 'Fast Web View' to ensure optimum performance of the review system
The maximum file size for an individual PDF file is 50 MB
PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then they must be OCR’d (Optical Character Recognition)
All portrait pages are presented in portrait and All landscape pages are presented in landscape
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Large number of major protocol deviations not reported in the CSR
Inadequate monitoring activities performed at site
None of the above
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Major
Minor
Critical
None of the above
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69.84 – 143.19 %
90.00 – 111.11 %
80 – 125 %
None of the above
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True
False
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True
False
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EMA/CPMP/EWP/280/96 Corr1, Nov 2014
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **, Jan 2010
Appendix IV of CPMP/EWP/ QWP/1401/98 Rev.1
EMEA/CHMP/EWP/192217/2009 Rev. 1/Corr. 2**
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