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发帖数: 25265 | 1 Investigator's brochure
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The Investigator's Brochure (IB) is a comprehensive document summarizing the
body of information about an investigational product ... 阅读全帖 |
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发帖数: 25265 | 2 A medical device is a product which is used for medical purposes in patients
, in diagnosis, therapy or surgery[citation needed]. Whereas medicinal
products (also called pharmaceuticals) achieve their principal action by
pharmacological, metabolic or immunological means. Medical devices act by
other means like physical, mechanical, physico-chemical or chemical means.
Medical devices are included in the category: Medical technology.
Medical devices include a wide range of products varying in comp... 阅读全帖 |
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发帖数: 25265 | 6 来自主题: MedicalDevice版 - FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖 |
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A*****8
发帖数: 8590 | 7 Report Information:
Publication date: 11/07/2012
Number of Pages: 145
Report Details:
In 2011, the medical device market worldwide was worth $309bn, with high
single-digit growth from the year before . Despite being a vast and mature
market, there are number of sectors likely to experience fast growth during
the next 10 years. Much of this growth is linked to the prevalence of a
number of diseases worldwide, as well as an aging population. The rise in
neurological disorders will drive both the d... 阅读全帖 |
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m****s
发帖数: 18160 | 8 【 以下文字转载自 Biology 讨论区 】
发信人: JoyceS (JoyceS), 信区: Biology
标 题: Global leading pharma招聘：【Medical Writer】地点：上海
关键字: Medical Writer Clinical
发信站: BBS 未名空间站 (Thu May 8 10:39:05 2014, 美东)
请联系Joyce：d******[email protected]
欢迎有相关经验者，或医药背景应届硕士积极申请，英文要求精通
也非常欢迎想回国发展的其他专业人士联系
POSITION SUMMARY 职位概要
Medical Writers collaborate with Point of Contact medical writers (PoC), and
members of the clinical study team in Development Sites overseas to
interpret study results and prepare Clinical Study Reports (CSRs) a... 阅读全帖 |
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m****s
发帖数: 18160 | 9 【 以下文字转载自 Pharmacy 讨论区 】
发信人: JoyceS (JoyceS), 信区: Pharmacy
标 题: Global leading pharma招聘：【Medical Writer】地点：上海
关键字: Medical Writer Clinical
发信站: BBS 未名空间站 (Thu May 8 10:38:06 2014, 美东)
请联系Joyce：d******[email protected]
欢迎有相关经验者，或医药背景应届硕士积极申请，英文要求精通
也非常欢迎想回国发展的其他专业人士联系
POSITION SUMMARY 职位概要
Medical Writers collaborate with Point of Contact medical writers (PoC), and
members of the clinical study team in Development Sites overseas to
interpret study results and prepare Clinical Study Reports (CSRs)... 阅读全帖 |
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D*****r
发帖数: 6791 | 10 by Mark Twain from Fables of Man （1908）
Little Bessie was nearly three years old. She was a good child, and not
shallow, not frivolous, but meditative and thoughtful, and much given to
thinking out the reasons of things and trying to make them harmonise with
results. One day she said --
"Mamma, why is there so much pain and sorrow and suffering? What is it all
for?"
It was an easy question, and mamma had no difficulty in answering it:
"It is for our good, my child. In His wisdom and mercy the Lo... 阅读全帖 |
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l*****a
发帖数: 38403 | 11 Seven sayings
The seven sayings form part of a Christian meditation that is often used
during Lent, Holy Week and Good Friday. The traditional order of the sayings
is:[13]
Father forgive them, for they know not what they do (Luke 23:34).
Truly, I say to you, today you will be with me in paradise (Luke 23:43).
Woman, behold your son: behold your mother (John 19:26-27).
My God, My God, why have you forsaken me, (Matthew 27:46 and Mark 15:34).
I thirst (John 19:28).
It is finished (John 19:30).
Fat... 阅读全帖 |
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B******u
发帖数: 23763 | 12 多谢多谢，
等待会儿俺上班了再仔细看哈。
先两个包子吧。
standards/documents/harmonised-standards-legislation/list-references/iv-
diagnostic-medical-devices/index_en.htm |
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B******u
发帖数: 23763 | 13 说实话，一个问题是，
俺还真不知道那个玩意该长个啥样子，
问头，头说，我们是在准备打入欧洲市场，
他们也不知道。
standards/documents/harmonised-standards-legislation/list-references/iv-
diagnostic-medical-devices/index_en.htm |
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G***Y
发帖数: 9698 | 14 到歐洲原產地購名牌不一定抵
【明報專訊】匯豐發表全球奢侈品指數報告，變相為名牌格價。一般人認為到其生產地
購買奢侈品最為划算，不過，報告顯示，原來於香港購買法國名牌香奈兒（Chanel）及
卡地亞（Cartier）產品，比原產地法國的價錢廉宜近9%，在日本購買瑞士名表勞力士
，甚至可較產地平逾一成。
日本購勞力士較產地廉逾一成
以Chanel 11.12經典手袋為例，香港該款產品的價格指數僅94，是9個地區中最廉宜，
價格比生產地法國低近9%；Cartier Trinity三色金戒指香港價格指數亦只是91，較英
國、中國、日本等地廉宜最多逾一成。
報告表示，雖然Chanel及Cartier的熱賣產品全球的定價比較一致，但對於大部分奢侈
品如手袋、首飾及服裝，其內地的定價較歐洲地區溢價近37%。為減低各地區的價格差
異，報告建議奢侈品牌在新品發布前，應預先調控價格於一致水平（pre-harmonised）
。如 Prada（1913）的春裝系列，其內地最新定價只較意大利高出10%，較目前高出40%
下降30個百分點。
報告又表示，法國專門生產戶外運動裝備的Moncler，產品價格存在最大... 阅读全帖 |
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w******e
发帖数: 1187 | 15 The disposable academic
Why doing a PhD is often a waste of time
ON THE evening before All Saints’ Day in 1517, Martin Luther nailed 95
theses
to the door of a church in Wittenberg. In those days a thesis was simply
a position one wanted to argue. Luther, an Augustinian friar, asserted that
Christians could not buy their way to heaven. Today a doctoral thesis is
both an idea and an account of a period of original research. Writing one
is the aim of the hundreds of thousands of students who embar... 阅读全帖 |
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e*****k
发帖数: 282 | 16 Why doing a PhD is often a waste of time
Dec 16th 2010 | from PRINT EDITION
from PRINT EDITION | Christmas Specials
ON THE evening before All Saints’ Day in 1517, Martin Luther nailed 95
theses to the door of a church in Wittenberg. In those days a thesis was
simply a position one wanted to argue. Luther, an Augustinian friar,
asserted that Christians could not buy their way to heaven. Today a doctoral
thesis is both an idea and an account of a period of original research.
Writing one is the aim... 阅读全帖 |
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发帖数: 25265 | 17 The CE markCE marking (also known as CE mark) is a mandatory conformance
mark on many products placed on the market in the European Economic Area (
EEA). With the CE marking on a product the manufacturer ensures that the
product is in conformity with the essential requirements of the applicable
EC directives.[1] The letters "CE" stand for "Conformité Européenne" ("
European Conformity").[2]
Contents [hide]
1 Meaning
2 Countries requiring the CE marking
3 Rules underlying CE marking
4 Self-certif... 阅读全帖 |
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发帖数: 25265 | 18 Good Laboratory Practice
In the experimental (non-clinical) research arena, the phrase good
laboratory practice or GLP specifically refers to a quality system of
management controls for research laboratories and organizations to try to
ensure the uniformity, consistency, reliability, reproducibility, quality,
and integrity of chemical (including pharmaceuticals) safety and efficacy
tests.
GLP was instituted following cases of animal test fraud by pharmaceutical
and industrial chemical (mainl... 阅读全帖 |
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发帖数: 25265 | 19 European Medicines Agency
The European Medicines Agency (EMA) is a European agency for the evaluation
of medicinal products. From 1995 to 2004, the European Medicines Agency was
known as European Agency for the Evaluation of Medicinal Products.[1]
Roughly parallel to the U.S. Food and Drug Administration (FDA), but without
FDA-style centralization, the European Medicines Agency was set up in 1995
with funding from the European Union and the pharmaceutical industry, as
well as indirect subsidy fr... 阅读全帖 |
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发帖数: 25265 | 20 Informed consent
From Wikipedia, the free encyclopedi
"Informed Consent" redirects here. For the House episode, see Informed
Consent (House). For the website, see Informed Consent (website).
Scales of justice
Tort law
Part of the common law series
Intentional torts
Assault · Battery
False imprisonment
Intentional infliction of
emotional distress (IIED)
Transferred intent
Property torts
Trespass (land · chattels)
Conversion · Detinue
Replevin · Trover
Defenses
Assumption of risk
Comparative negli... 阅读全帖 |
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e***e
发帖数: 3872 | 21
FRANZ: [cont.]
Doctors and philosophers all tell me how marvellously
the inclinations of the mind harmonise with those of the
machine it lives in. Convulsive seizures are inevitably
accompanied by dissonant vibrations in the machine;
passions damage the vital force; the overloading of the
spirit weighs down the vehicle. What then? If one could
find how to smooth this untrodden road for Death to
enter the very fortress of life! how to destroy the body
via the soul! An incompara |
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