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Glossary

Risk-benefit balance

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An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. 

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Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product…
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Clinical Research

Big enough to deliver and small enough to care HealthTech developers, including…

Other glossary definitions

I

International Committee for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is…

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T

Target Product Profile (TPP)

Target product profile (TPP) in the US A TPP can be prepared by a sponsor…

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