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Safeguarding public health
Workshop – Topic Areas
Name: Malcolm DashDate: 26 October 2009
Slide 226 October 2009
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What are the characteristics of a good and poor assessment report?
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Slide 326 October 2009
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What represents “poor use of resources” when it comes to writing assessment reports?
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Slide 426 October 2009
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Discuss what you want/need to see in an RMS report
How much detail should be included?
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Slide 526 October 2009
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Examples of good focused assessment reports
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Slide 626 October 2009
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Areas not well covered: GMP, sterilisation, BE, bioanalytical methods
Slide 726 October 2009
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Topic areas
Analytical methods and reference standards
Pharmaceutical development
Stability
Impurities in API
Specifications
Dissolution testing
Slide 826 October 2009
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Discuss the best ways to present information in the assessment report on the validation of an analytical method
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Slide 926 October 2009
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Pharmaceutical Development & Manufacturing Process Development
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Slide 1026 October 2009
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Stability
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Slide 1126 October 2009
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What do we need to include in the AR to demonstrate that a company has addressed the issue of impurities in the finished product?
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Slide 1226 October 2009
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Specifications
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Slide 1326 October 2009
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When is it important to consider the discriminating nature / capability of a dissolution test?
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