The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The ...
The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is ...
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it. The European Medicines Agency (EMA) published a draft reflecting paper ...
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