regulatory,

FDA Quality Considerations for Continuous Manufacturing

This guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).

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regulatory,

Reflection paper on the qualification of non-genotoxic impurities

The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines state that qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level (s) specified

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regulatory,

Mobile scanning and other technologies in the labeling and package leaflet of centrally authorized medicinal products

With the availability of new communication technologies it has become apparent that patients / users / health care professionals can benefit from information provided by electronic formats. In this context, there are two types of rapid response (QR) codes and two-dimensional (2D) barcodes, or Near-field Communication (NFC), among others, as an additional way of providing information to patients and health care professionals.

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