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研究围绕生命科学行业的独特挑战和问题

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欧盟 M D R 标签 :

最新的医疗器械标签要求指南

2017 年 5 月 26 日,欧盟医疗器械条例 2017/745(欧盟 MDR)正式生效,致使欧盟的监管格局发生了重大转变。

‘Qwality’ Not Included

The ability to rate translation quality in an effective and uniform manner has long been a requirement of the industry, but is also crucial to high-risk projects such as translation for patient safety medical device labelling.

A New Era of Patient-Centricity

Patient-centricity has become one of the new catch phrases of the pharmaceutical industry. Indeed, although the industry appears to have patient-centricity in its DNA, the voices of the patients can easily get lost in all the hundreds of details in the drug development process.

China’s Ambitious Path Towards Universal Health Coverage (UHC)

In the last publication of CSOFT’s series on China’s healthcare reforms, the topic of how China’s radical regulatory makeover is shaking the entire pharmaceutical industry, both globally and domestically, was discussed.

Ensuring Quality In A Strategic Medical Writing Partnership

We are talking about two things here – quality, and medical writing – so first let’s examine both of these terms.Quality really means different things to different people – some consider it to be a degree of excellence, while others may see it as ‘being fit for purpose’. While perfection would be desired, it is always important to balance effort against output. Hence, rather than targeting perfection, it is important to focus on what matters: those critical data points that will make all the difference.

How The NMPA Is Changing The Chinese Pharmaceutical Industry

Since 2015, the NMPA (CFDA) has initiated a series of reform documents, with the purpose of pushing the Chinese pharmaceutical and medical device industry to a more mature and globalized environment.

How To Get Ready For eCTD Submission?

China is currently recognized as the world second largest pharmaceutical market. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies.

The Ins and Outs of Translation Memory Maintenance

Translation memory is a vital part of your business’s assets. As your business experiences change and grow, your TM will expand as well. In an ideal situation, it should continuously learn your company’s multilingual content and improve itself to provide you with efficiency, accuracy, and low costs that are necessary for successful globalization. Whereas in reality, it often collects and stores unwanted data.

MEDICAL DEVICE MARKET 亚洲医疗器械市场概况和监管格局

随着亚洲地区经济的增长,医疗健康领域支出不断增加,强有力的监管改革也稳步进行,亚洲必将成为全球医疗器械公司的下一个热点区域。本白皮书将详细分析亚洲地区七个主要医疗器械市场(中国,日本,韩国,澳大利亚,马来西亚,泰国和印度)的市场前景和监管格局。