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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…

Other glossary definitions

A

Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees. Applicant…

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M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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