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Addendum to ICH E6 (R2)
Angela Del VecchioDirettore Office Ispezioni GCP
XXVI CONGRESS NATIONAL GUITAR
Palermo, 24 Maggie 2017Dichiarazione DI transparent/interest×Le opinion espresso in quest presentation
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What is addendum to ich e6?
An addendum to ICH E6 is a document that contains additional information or changes to the original ICH E6 guideline.
Who is required to file addendum to ich e6?
Any organization or individual conducting clinical trials that is following the ICH E6 guideline may be required to file an addendum.
How to fill out addendum to ich e6?
The addendum to ICH E6 should be filled out according to the specific instructions provided by the regulatory authorities or governing bodies.
What is the purpose of addendum to ich e6?
The purpose of an addendum to ICH E6 is to provide updated or additional guidance on conducting clinical trials in accordance with current regulations and best practices.
What information must be reported on addendum to ich e6?
The information that must be reported on an addendum to ICH E6 may vary depending on the specific changes or updates being made.
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