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Counting Down the Top 10 Articles of 2022 - #7: Manage Challenges from the EU 536/2014 Clinical Trials Regulation

Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #7, we cover study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.

Regulation EU No 536/2014 on clinical trials brings changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.
Regulation EU No 536/2014 on clinical trials brings changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.

In our top 10 of 2022: Regulation EU No 536/2014 on clinical trials—a binding legislative act for each member state, overruling national law—came into force on January 31, 2022, to simplify clinical trial preparation and activation. With it will come many changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.

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FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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FDA warning letters surge - is your team prepared?