Module 1 2021

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25/06/2021

References

The Organisation for Professionals in Regulatory Affairs

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Recommended references

• ICH • http://www.ich.org/products/electronic-standards.html

• US • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSu bmissionRequirements/ElectronicSubmissions/ucm153574.htm

• Europe • http://esubmission.ema.europa.eu/index.htm

The Organisation for Professionals in Regulatory Affairs

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