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As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide track and trace compliance strategies.
Tags: serialisation, serialization, pharma, track, trace, track and trace, track & trace, supply chain, supply chain security, FMD, DSCSA, deadlines, implementation, CMO, barcode, master data,
When examining the known future for GMP compliance, there are a range of changes that the industry needs to brace for, including a new EU delegated act focused on investigational medicinal products. Here Pharma IQ outlines the GMP updates the market will soon be facing.
While the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a Learn more
With a view to contribute to the industry’s ongoing progression, Pharma IQ collates the lessons learnt by hospitals during the implementation of UDIs for medical devices and how the conduct of manufacturers and hospitals could be altered to not just optimize this project’s roll out but to avoid incurring any detriment.
The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package Learn more
Kevin Mooney– Chairman Drafting committee for the Rules of Procedure for the United Patent Court discusses the pharmaceutical sector in relevance to the changing landscape attached to the UPC and how this will influence the industry. Also, refreshed litigation strategies are analysed as firms look to avoid preemptive strikes from third parties.
Vjet whitepaper
Implementation deadlines are looming large, leaving an urgent need for both pharmaceutical and medical device manufacturers to find and implement solutions to stay compliant. With only a few years left to comply with pack level serialization in the US and Europe, the time to complete the changes to existing or new production and packaging lines is Learn more
Pharma IQ presents the top content pieces for 2015 in this annual bumper, so you can browse through some of this year’s best articles to feature on the portal.