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19-Oct-2019 12:23

This article discusses the evolution of the EU regulatory expectations related to the IMPs and how these expectations have influenced the required quality information to include in the IMPD for biological products.

First, an overview of regulations, guidelines and events, impacting quality requirements of IMPs, will be presented together with a brief summary of the two procedures currently available for submission of CTAs in the EU.

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The implementation of the Directive has, however, led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each concerned MS.

Currently, before a clinical trial can be conducted in one EU/EEA MS, a Clinical Trial Application (CTA) has to be submitted and approved by each concerned CA and EC.

The IMPD is one of the core documents that compose the CTA.

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Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC [1], defining the requirements for the conduct of clinical trials in the EU.

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The IMPD is one of the core documents that compose the CTA.

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Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC [1], defining the requirements for the conduct of clinical trials in the EU.

In today's technology-driven world, "innovation" has become a basic expectation.

IT leaders are tasked with making technical magic, improving customer experience, and boosting the bottom line -- yet often without any increase to the IT budget.

The IMPD provides quality and non-clinical data on the IMP, in addition to data from previous clinical trials and human experience to evaluate the benefits and risks associated with the administration of an IMP during the conduct of the clinical trial.