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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

I

Individual Case Safety Report (ICSR)

An Individual Case Study Report is an adverse event report for an individual patient. Individual…

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P

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license…

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