您好，感谢您对我们的关注与支持！在此我们诚挚的邀请您参加由 ECI 与 VCLS 联合主办的新药出海系列直播会议：

欧美注册申报路径及与监管机构沟通模式探讨

近几年来，中国药企走出国门开拓海外市场已经成为共识，并形成了一个新的浪潮。尤其是创新类产品，美国和欧洲一直是最具吸引力的海外市场，但是一种新药在进入美国和欧洲市场之前所要做的准备是极其复杂的，从最初的药物发现到获得 FDA 和 EMA 批准，再到最终上市，可能需要很多年的时间。在产品开发过程中，许多因素都会影响药物是否能够成功获批并上市，而其中对美国和欧盟法规与要求的透彻理解这一因素往往会被低估。目前药物开发过程的特殊化日益显著，适用于某一个项目的注册申报路径，对于治疗同一症状的另一个项目来说，可能是无效或者不适用的，对于不同地区亦是如此。因此旨在将药品推向全球市场的中国企业应该充分认识不同地区的法规环境差异，并制定相应匹配的开发和申报路径 。 

在本次网络研讨会中，我们将讨论：

1. 两地监管机构在审评团队、会议安排、临床试验申请(IND vs CTA)方面的异同点
2. 与 FDA 及 EMA 进行沟通的时机和方式
3. FDA 和 EMA 的加速审评路径

特邀演讲嘉宾：

会议时间：2022 年 6 月 16 日 19:00-20:00

会议形式：ZOOM 在线会议

会议报名方法：

• 点击此处，进行在线注册。会议费用：免费。
• 注册成功后，我们会通过邮件将登录链接发送给您，烦请注意查收。

诚挚期待您的参与！

顺祝商祺!

EC Innovations 生命科学事业部 

游戏本地化翻译的必要性

我们对于本国或者本地的文字往往具有比较特殊的敏感，比如说在国外看到了写着中文的东西就会特别看两眼。在其他城市看到了自己的家乡话就会觉得更加亲热，在游戏中也同样如此。看到了自己国家或者城市的语言出现在了游戏上，往往可以勾起玩家的兴趣，打开更多的游戏市场。而对于自己国家来说，能够懂得游戏说什么，怎么玩，这样往往可以让玩家群体更大，如果看不懂，不知道，这样的游戏还会有当地玩家吗？可想而知。

游戏本地化翻译需要注意的方面

• 游戏翻译的时候不仅仅需要翻译游戏里面的一些操作和内容，更是需要对游戏的背景也有比较好的翻译。有经验的玩家都知道，游戏的背景故事有时候甚至比游戏本身更有意思。而了解背景故事，往往对于玩游戏也有一定的推进作用。

• 游戏翻译的时候不仅仅需要翻译游戏里面的一些操作和内容，更是需要对游戏的背景也有比较好的翻译。有经验的玩家都知道，游戏的背景故事有时候甚至比游戏本身更有意思。而了解背景故事，往往对于玩游戏也有一定的推进作用。

About The Meeting

Nov. 19th – Dec. 2nd, 2016, EC Innovations’ 7-day business forum “One Week” was successfully held in Shenyang, China to mark the 10 year anniversary of cooperation with SAP. Six representatives including principals of BPM, QA managers, project managers and delivery managers from SAP China attended the open forum. The program was implemented by ECI’s Shenyang branch, who showed warm hospitality during the guest reception.

In addition to the celebration, the members of both groups from SAP and EC Innovations also discussed and explored a dozen topics from machine translation and CAT instruction, through ERP localization features to methods of terminology review and process optimization. ECI Shenyang made this gathering multi-faceted by celebrating, exchanging experiences, and problem solving. This attributed not only to a mutual understanding on abusiness level, but also strengthening existing relationships.

ECI Localization Solutions Tailored for SAP

With expertise in customized solutions, EC Innovations always sticks to the dream of empowering communications and striving to provide high quality services for nearly 20 years. EC Innovations has been a reliable and professional business partner for SAP since 2007. Being recognized for our reliability and excellence in language services, as well as our loyalty and exemplary work, EC Innovations won its official membership into the SAP PartnerEdge® Program in 2013; being the only SAP official language service providerfor simplified Chinese.

During the past 10 years of cooperation and always having uncompromising high quality translation results, EC Innovations has cultivated a mature and stable team with professional experience customized for SAP. With subject-matter expertise and best practices, each member of the team is proficient in the SE63 translation environment, familiar with SAPterm, Styleguide, and SAP-relevant workflows. As of today, EC Innovations has reached an output of over 50 million words for SAP.

More information at （SAP Localization）>>

ECI’s knowledge and expertise will be invaluable to YaTuo’s continuous enhancements while YaTuo, with its dedicated team of research and development experts in Machine Translation (MT) theory and technology, will offer an industry leading MT system.

The NiuTrans MT team from YaTuo are industry leaders in technical research and product engineering globally. The core members of NiuTrans team are also members of the prestigious Natural Language Processing Laboratory at Northeastern University (NEU NLP Lab). Founded in 1980 by the first Ph.D. Supervisor in the computational linguistics field in China, Tianshun Yao, the NEU NLP has been continually focusing on Machine Translation technology into multiple languages for more than 34 years.

The ECI and YaTuo relationship— the heart of the partnership was the development and sharing of the NiuTrans system and the NiuTrans Server. This system marks an important milestone in the development of how MT is used in the translation & localization industry. YaTuo successfully developed the NiuTrans Server MT system for ECI and is the first private cloud platform system targeted at enterprise-level clients, worldwide. The NiuTrans Server is accompanied by the highest confidentiality protection; meaning the privacy of client & user information is completely assured; this includes high volume e-commerce certification, physical security and application security to name a few. Meanwhile, based on the private cloud server, the co-development between the two companies has established a corpus of ten million words, which enables EC Innovations to provide a large quantity of high quality translation & localization options for our clients requiring MT.

EC Innovations, Inc.

Precision Matters in Translation ℠

For over 17 years, EC Innovations has specialized in customized solutions and subject matter expertise to fit almost any budget for most industry verticals.

Originally known as a supplier to suppliers, ECI has quickly become one of the fastestgrowing language service providers in the marketplace.

Today, EC Innovations has grown into 14 strategically located global offices, 300+ full-time employees; offering full localization support into 60+ languages.

EC Innovations continues to build its reputation as a customer-centric organization with a keen focus on high quality standards and technological creativity to overcome any obstacle and ultimately add true value to any localization program.

Website: www.ecinnovations.com

Contact: zacs@ecinnovations.com

Hangzhou YaTuo Company

Established in 2012, Hangzhou YaTuo Company is a high-tech company that specializes in the industrial application of multi-language MT technology where an impressive 40% of its employees have a doctorate degree. YaTuo has built and maintains a close strategic partnership with their alma mater NEU NLP Labs, providing strong, stable and innovative technical support to MT technology applications. YaTuo’s commitment to being a technological leader in MT system applications is solely driven by its desire to provide their partners with the most effective and customized MT systems available in the industry.

Website: www.zjyatuo.com

EC Innovations history with Siemens dates back to 2004. Since the inception of this partnership there has always been a close cooperation between EC Innovations and Siemens. Due to Siemens’ stringent quality requirements on translation, delivering translation results up to Siemens’ standards is extremely challenging for any language service provider. Over the past 10 years, with uncompromising high quality translation results always, ECI hasconsistently exceeded Siemens’ expectations.

In an effort to enhance their own knowledge of their partners’ capabilities, including the category for translation/localization services and technologies, Siemens performs an evaluation and reassessment of their strategic partnerships every two years. Since having been awarded with such a prestigious rating as “Outstanding Supplier”, EC Innovations has never relinquished the title. The achievement is very unique for the language services industry. This reinforces the fact that EC Innovations’ delivers high quality results, innovative technologies and an exemplary customer-centric approach within a professional team orientated environment.

It is ECI’s dedication to its most renowned mottos: “Quality is the Boss Who Pays Our Salary” and “Precision Matters in Translation” which is root-cause to our collective ambition to always strive to become every client’s strategic, reliable, and long-term business partner. The spirit of growing in tandem with the client is engrained into EC Innovations’ corporate core values, and continues to inspire every team member within ECI globally.

About EC Innovations

EC Innovations (www.ecinnovations.com) empowers communications with quality already priced into rates and customized technology solutions used by the world’s largest and most recognized companies. An Asia-Pacific headquartered leader in translation/localization since 1997, with offices around the globe and linguists in 100+ countries; EC Innovations continues to set its clients apart from their competition by improving global brand recognition, increasing cost-efficiency and speeding time-to-market through the use of a true Global Communication Supply Chain.

Specialties

• Localization/Translation

• Revolutionary Translation Business Management System (TBMS) – a user-friendly localization project-, process- and business-management suite

• Customized ‘Piecemeal’ Solutions

• Proven Methodologies for Cutting Costs While Continuously Improving the Quality Standard

SAP is the world leader in enterprise management software solutions, and is present in over 130 countries globally.

SAP’s PartnerEdge® Program is the official approved partnership program designed to reward partners for their loyalty and exemplary work with SAP and its affiliates. Membership into the SAP PartnerEdge®Program is a strong indicator of the partner’s reliability and excellence in language services business and the importance of the long term partnership. EC Innovations has been a reliable and professional business partner of SAP since 2006. During the past 7 years of cooperation, EC Innovations has been recognized for its superior quality of service, expertise in translation/localization, their dedicated project team(s) and their exemplary technology solutions.

News of this honor has resonated throughout the entire EC Innovations family. This achievement is shared by all those individuals that continue to go above and beyond for their clients. These efforts have made EC Innovations synonymous with value.

The honor affirmed by SAP will bring EC Innovations distinct opportunities and challenges; with them, EC Innovations will continue to build on their fundamental mottos, ‘Quality is the Boss Who Pays Our Salary’ and ‘Precision Matters in Translation’.