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Glossary

Good Manufacturing Requirements (GMP)

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Good Manufacturing Practice. This is a recognised standard for pharmaceutical processing and manufacture ensuring medicinal products are consistently produced and controlled 

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Chemistry, Manufacturing & Controls (CMC)

Overcome regulatory, scientific and technical challenges ensuring compliance, flexibility on the production…
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Cell, Gene and Tissue Therapies

Gene therapy, somatic or stem cell therapy and tissue engineering are at…

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M

Missing information

Gaps in knowledge about a medicinal product, related to safety or use in particular patient populations, which could…

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S

Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug…

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