The revisions to European Union (EU) Annex 1 set the stage for the future direction of the pharmaceutical/biotechnology industry. This document is one of the main EU regulatory guidelines for Risk Management and Contamination Control (Eudralex Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products) and also serves as the blueprint for the strategies and policies implemented by the many pharmaceutical/biotechnology companies in the United States (US), as US companies frequently consider the EU market.
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The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...
The Factor Podcast: The Role of Human Factors in Medical Product Development
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...