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Glossary

Development international birth date (DIBD)

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Date of first approval (or authorization) for conducting an interventional clinical trial in any country (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Other glossary definitions

M

Manufacturer

The natural or legal person with responsibility for the design, manufacture, packaging, and labeling of…

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J

Justification Table

In relation to Policy 70, to be completed by the Applicant to justify the proposed…

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