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E5 guideline - PowerPoint PPT Presentation


Implementation of the E5 Guideline: Status and Next Steps

Implementation of the E5 Guideline: Status and Next Steps

Implementation of the E5 Guideline: Status and Next Steps. ICH and GCG. International leadership role in scientific harmonization Requirements for drug development must have a scientific basis Value of harmonization of regulations Brings innovative medicines to patients faster

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258 views • 9 slides



E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground

E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground

E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground. E5 guideline is something like a conjecture that has not been proved yet. I am sincerely grateful to those who made the first “let’s sink or swim” decision, based on their expertise. Must be carefully applied.

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144 views • 3 slides


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