Implementation of Regulatory Aspects of Clinical Research is critical - PowerPoint PPT Presentation

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Implementation of Regulatory Aspects of Clinical Research is critical

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One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: – PowerPoint PPT presentation

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Title: Implementation of Regulatory Aspects of Clinical Research is critical


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Implementation of Regulatory Aspects of Clinical
Research is critical
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(No Transcript)
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FDA requirements on regulatory aspects of
clinical research
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FDA requirements on regulatory aspects of
clinical research
  • 21 CFR Part 11
  • 21 CFR Part 16
  • 21 CFR Part 50
  • 21 CFR Parts 50 and 56
  • 21 CFR Part 54
  • 21 CFR Part 58
  • 21 CFR Part 312
  • 21 CFR 312.120
  • 21 CFR Part 314
  • 21 CFR Part 320
  • 21 CFR Part 511
  • 21 CFR Part 514
  • 21 CFR Part 601
  • 21 CFR Part 812
  • 21 CFR Part 814

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EU requirements on regulatory aspects of clinical
research
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Some landmarks in clinical and medical research
in the EU
  • During the course of its journey, regulatory
    aspects of clinical research have been through a
    series of milestones. Each of these has been
    responsible for cultivating a culture of
    regulatory compliance in the EU. These
    declarations on the regulatory aspects of
    clinical research have served to be the guiding
    principles of clinical and medical research in
    the EU
  • The Declaration of Helsinki of 1964
  • Code of Nuremberg of 2008
  • Declaration of Geneva of 2008
  • Amendment to the Declaration of Helsinki of 2008

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