学习 CDER如何推进监管科学以保护公众健康（一）

flydengfeng

摘自微信公众号：药品注册英语学习平台；作者：Tony Zhang

Learn how CDER is advancing regulatory science to protect public health.

学习 CDER如何推进监管科学以保护公众健康

CDER Researchers – In Their Own Words

CDER研究者 – 用他们自己的话说

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CDER的监管科学-来自CeliaCruz, Ph.D. 的播客

CDER监管科学CeliaCruz Ph.D来自药品注册英语学习平台00:0002:41

Dr. Celia Cruz explains how CDER’s Division of Product Quality Research works to enable innovation by focusing on increasing product quality and ensuring drug products are more widely available to the American public.

CeliaCruze博士解释CDER的产品质量研究部门是如何通过专注于提高产品质量和确保产品更广泛的提供给美国公众工作来实现创新的。

Text Slide 文本幻灯片

Celia Cruz, Ph.D. CeliaCruz 博士

Director, Division of Product Quality Research 产品质量研究部门主任

Office of Pharmaceutical Quality 药品质量办公室

Office of Testing and Research 测试与研究办公室

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Dr. Cruz: At one point in my career, I had the choice to continue in industry or think about what does regulatory agency do and what are the things you can learn there that you really can’t learn anywhere else in the world. So I decided to join the FDA about seven years ago and learn the concept of review, inspections, and policy development for products.

Cruz博士：在我职业生涯的某个时刻，我有选择继续在行业或思考监管机构做的事情，在那里你可以学到世界上任何地方都学不到的东西。所以，我在7年前决定加入FDA，并学习审评和检查的概念以及为产品制定政策。

Dr.Cruz: So the goal of our research is called regulatory science, which is understanding what the challenges would be in the future in terms of regulating certain technologies. So it’s not our goal to develop our own medicines, it’s to understand what is needed to ensure the quality of medicines made by this technology in thisfuture.

Dr. Cruz: 所以我们研究的目标被称为监管科学，它就是理解未来在规范某些技术方面所面临的挑战。因此，我们的目标不是开发我们自己使用的药物，而是理解在未来使用这些技术时需要什么来保证药品的质量。

It is a very important national priority that we try to modernize the pharmaceutical industry so that we can solve issues such as supply of drugs, reduce drug shortages and recalls. And we think that one of the ways to do this is to modernize the equipment, the methods, and the approaches to making medicines in the future.

我们努力实现制药工业的现代化以解决诸如药品供应、减少药品短缺和召回等问题，这是我们国家非常重要的优先事项。我们认为达到这一目标的方法之一，就是在未来实现药物制造的设备、方法和途径的现代化。

So we’re trying to enable innovation by focusing on things that will make product quality higher and drug products more available to the American public. And we think the best ways to do that is to enable manufacturing science innovation, such as things like 3D printing which will allow us to make different types of dosage forms.

所以，我们通过专注于那些能够提升药品质量及使得美国公众更容易获得药品的事情上，试图实现创新。我们认为最好的方法是制造科学的创新，例如3D打印，它将使我们可以制造不同种类的剂型。

Continuous manufacturing, which will help us make product faster and more readily accessible, and advanced analytics we will be able to detect product quality issues in a faster and more accurate way. So to us those are three ways that we can improve the adoption of innovation in the pharmaceutical industry.

连续制造将有助于我们生产产品更快，更易获得以及先进的分析，我们将能够用更快更准确的方法来监测产品质量。所以对我们而言，这些是制药行业采用的创新中我们认为可以改善的三种方式。

One of the important parts of our mission is to be ready for what comes up next. So for example in our laboratories we make a great effort to buy the pieces of equipment that represent what might be out in industry, so we can have state of the art facilities.

我们任务的一个重要部分就是为接下来的事情做好准备。因此，例如在我们实验室，我们努力购买设备部件，这些部件代表了行业里可能过时的东西，所以我们能够拥有先进的设备。

And also understanding the methodologies that are coming up. So we stay alert in terms of readiness for new technologies by collaborating with academia and supporting things such as research that goes on in industry.

同时我们了解了即将出现的方法。因此，我们通过学术合作和支持诸如工业界的研究，对新技术的准备就绪保持警觉。

Industry can come to the FDA and talk about any new emerging technology that they’re interested in adopting and get early feedback from the FDA in terms of what are the potential things that they can work on to make this more easily adoptable in the pharmaceutical industry.

工业界可以和FDA讨论任何他们有兴趣采用的新兴技术，并在如何使这些技术在制药界更易接受可以做哪些潜在工作方面从FDA获得早期反馈。

One of the concepts is that innovation and regulatory agencies sometimes don’t go hand in hand, but actually regulatory agencies can do a lot in terms of adopting innovation.

其中一个概念是创新和监管机构有时候不会携手并进，但实际上监管机构可以在采用创新方面做很多事情。

I find the job extremely rewarding and it’s very few places that you can do science and policy in the same place. So to me this is one of the most rewarding jobs I’ve ever had, and I hope to have it for a long time.

我发现这项工作非常有意义，而且能在同一个地方做研究和政策的地方很少。因此，对我而言，这是我从未做过的最有意义的工作之一，我希望长时间做下去。

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常用短语

regulatory agency 监管机构

in terms of…在某方面；依据…

supply of drugs, reduce drug shortages and recalls 药品供应，减少短缺和召回

dosage form 剂型

more readily accessible 更易获得

stay alert 保持警觉

new emerging technology 新兴技术

get early feedback from 获得早期反馈

go hand in hand 携手前行

So to us 因此对我们而言

So to me 因此对我而言

常用语句

At one point in my career 在我职业生涯的某个时刻

It is a very important national priority that 这是国家一个非常重要的优先事项

One of the ways to do this isto 做这项工作的方法之一是

One of the important parts of our mission is to 我们任务的一个重要部分是

One of the concepts is that 其中一个概念是

I find the job extremely rewarding 我发现这个工作非常有意义

syhorchid

很好的英语学习平台

xqliu

学习一下啦，谢谢提供分享。