BTRA 640 University of Maryland Preclinical and Clinical Research Design Discussion

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1. For this week’s writing exercise, read the attached ICH E6 guidance on good clinical practices and write a 2-4 double spaced pages essay discussing the role and responsibilities of all stakeholders involved in clinical trials for the development of medicinal products for human use.

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Please note that for the first time in nearly 20 years, E6 has been revised to include additional stakeholder accountabilities. See the attached revision of the ICH E6, Revision 2, Integrated Addendum that highlights these key changes.

ICH E6(R2) Integrated Addendum

2)For this week’s writing assignment, you will be considering the BLA. Write a one or two page essay on what information is typically included in a BLA and how it differs from the information usually included in a NDA.

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