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INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER 2016

Investigational Medicinal Product Dossier 2016-2025 Form

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uh so welcome everyone to our webinar and the topic for today is effective impd writing we will be talking about the quality part uh i first i will introduce myself my name is ramona ruqianya i'm a head of the central functions for regulatory affairs at biomapas and also together with myself is agle de montevitchute agles medical writer today's agenda is you you see it and first we will go through regulatory guidelines highlighting critical points then structure and content of the impd also pointing out the main points later we present best practices in impd quality writing and finally we will discuss writing styles that produce accurate concise and clear technical text so let's agree on the terminology and scope so impd is investigational medicinal product dossier and impd includes summaries of information related to the quality manufacturing and control of any investigational medicinal product including reference products or placebo and data from non-clinical and clinical studies if

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