Earlier this week, China’s State Council announced plans to allow clinical trial data from other countries. As one of the largest pharmaceutical markets in the world, they are looking to bring in new, innovative therapies quicker. This comes on the heels of...
Let’s talk about quality! When it comes to translation there are two types of quality, the end product that is being delivered and the process it goes through to get there. Today we are going to look at the latter. Quality management systems, used by industries...
As we have discussed before, translators are increasingly being used in clinical settings. Utilizing interpreters, whether via phone or in person, enables patients or clinical trial participants to fully grasp information given to them. This allows clinicians...
Published in 2016, ISO 13485:2016 is in its third edition. ISO 13485:2016 comes on the heels of the ISO 13485:2003. Beginning in March 2016, there is a three-year transition period which comes to an end on February 28th 2019. These regulatory requirements undergo...
Quite a while ago we took a look at the role of machine translation (MT) in life science translations. It’s a hot topic of debate, and we can all see with a quick internet-based translation what the pitfalls are. These one-off quick translations of a block of...
Earlier this month we were looking at some of the factors affecting the life science industries today. Undeniably, the world’s aging population is changing the priorities of health care delivery and infrastructure all over the globe. With an older population,...
At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan’s “Rational Medicine”...
The life science sector is continually evolving and becoming ever more globalized. What used to work as a business model is progressively challenged by cost pressures, operating performance challenges as more mergers and acquisitions take place, and global trends in...
As summer is quickly drawing to a close, I want to take this time to explore some of the many upcoming industry events. In such a fast-paced industry, the life sciences industries are an area that provides numerous opportunities for continued learning. Understanding...
On March 4th of 2016, the China Food and Drug Agency (CFDA) officially launched their new classification system for chemical drugs. Under the Reform Scheme of the Classification System for Registration of Chemical Drugs (Reform Scheme), previously called the Drug...
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