by Regina Lynn Preciado | Nov 30, 2021
The COVID-19 pandemic put tremendous pressure on drug-development organizations to accelerate product development far beyond anyone’s wildest roadmaps. “The fast-track part [of producing COVID-19 vaccines] were regulatory approvals, funding, data analysis and...
by Regina Lynn Preciado | Oct 10, 2021
A reuse map is a blueprint for planned content reuse. Planned content reuse means that you identify ahead of time exactly which pieces of content will be reused in a specific output. With planned content reuse, authors do not have to do anything to make the reuse...
by Val Swisher | Aug 9, 2021
I recently came across a great commentary in the August 2021 issue of “Pharma Technology Focus.” The article is titled, “MDR set to transform how MedTech firms approach content management,” written by Barbara Peraltor, Director of Life Science Solutions at Amplexor. ...
by Val Swisher | Jul 12, 2021
EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) went into effect in May 2021, after about a year’s delay due to COVID-19. Medical device manufacturers have known about the new regulations for years and have been working to meet...
by Regina Lynn Preciado | Jun 25, 2021
I’ve had more than one conversation over the past several years about whether pharmaceutical companies were “ready” for structured content. After all, many of the benefits of structured content roll up into one key business need: scale. And scale — the ability...
by Max Swisher | Apr 26, 2021
A few years ago, the EU parliament passed EU Regulation 536/2014. Article 37 mandates that the results of pharmaceutical clinical trials need to be easily read and understood. Having easy-to-read information provides more transparency and accessibility for the general...
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