關於 human design report ，我們在網路上蒐集到這些相關的討論、資訊與評價

2019/11/16 (六)【臨床試驗系列】-醫藥學術專員(Medical Writer)培訓初階班

醫藥學術專員(Medical Writer)、也有人會稱它為臨床試驗設計人員。

他是臨床試驗的核心靈魂人物，需運用醫學科學知識與精準的英文寫作能力讓在不同國家執行的臨床試驗得以順暢地溝通與進行，因此必須有相當程度的英文能力。工作內容包含臨床試驗相關檔案的撰寫，例如:臨床試驗計劃書、知情同意書、臨床試驗報告撰寫等，另外行銷醫藥學術專員工作包括醫藥學術新知的報導並廣宣給更多的讀者，所以也是公司行銷重要的推手與後盾!

想知道這樣一個有挑戰性的工作更詳細的職務內容及需要具備什麼樣的能力嗎? 歡迎一起來參與這門被敲碗已久的Medical Writer培訓課程由專家來告訴你!!

🖍立即報名🖍https://slbiotech.pse.is/M3FMC

主辦單位：台灣光鹽生物科技學苑

課程地點：光鹽會議中心

課程日期：108年11月16日 (六) 09:00至17:00

授課師資：
黃靖雅 台塑生醫科技股份有限公司 臨床試驗事業部 醫藥學術副理

學員對象：
(1)對醫藥學術專員(Medical Writer)工作有興趣者
(2)參加過本學苑新藥或臨床試驗系列課程者
(3)目前從事臨床試驗相關工作者 (如PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA等…)

【授課大綱】

一、 新藥開發與CRO概述Overview of drug development and CRO
-Objective of clinical trials
-Phases of clinical trail
-Role of CRO in clinical trial

二、 醫藥事務與醫藥學術寫作之介紹Introduction of Medical Affairs / Medical Writing
-Clinical trial process
-Role of MA in different stages of clinical trial

三、 臨床試驗計劃書設計與開發Protocol design and development
-Protocol content of ICH E6
-Study design
-Endpoints considerations
-Patient eligibility
-Study procedure
-Statistical considerations
-Reference & tools

四、 知情同意書設計Informed consent form design
-Human Subject Protection
-受試者的知情同意與內涵
-受試者同意書內容
-受試者同意書寫作建議

五、 臨床試驗報告之準備Clinical study report preparation
-Report content of ICH E3
-Report sample template
-Reference & tools

六、 醫藥學術文稿的準備與出版Manuscript preparation and publication
-Manuscript IMRAD scheme
-Tips for manuscript writing
-Article submission and publication

七、 MedDRA的不良事件編碼Adverse event coding by MedDRA
-Introduction of MedDRA
-MedDRA hierarchical structure
-AE term selection: points for consideration

課程費用：每人2,100元 p.s.中午供餐及中場休息點心

*上課達滿時數六小時，核發本課程結業證書

【師資介紹】

黃靖雅

現職：
台塑生醫科技股份有限公司 臨床試驗事業部 醫藥學術副理

主要經歷：
台塑生醫科技股份有限公司 臨床試驗事業部 業務開發專員
台塑生醫科技股份有限公司 臨床試驗事業部 專案經理
台塑生醫科技股份有限公司 臨床試驗事業部 醫藥學術專員
ICH國際醫學用語詞典(MedDRA)認證編碼師

其他經歷：
中華民國醫事檢驗師
國立台灣大學醫學院生物化學暨分子生物學研究所
國立陽明大學生物醫學工程學院醫學生物技術暨檢驗學系畢

專長：
臨床試驗設計與規劃
受試者同意書(informed consent form)設計
受試者個案報告書(case report form)設計與製作
臨床試驗管理
藥物安全資料審核與編碼
臨床試驗報告撰寫
研究成果發表

【溫馨提醒】

本學苑採用線上繳費系統，請注意下列重要事項：

1.請學員報名務必先填寫Google報名表單後，再進入線上繳費系統。
2.本線上系統有下列兩種繳費方式
(1)信用卡繳費-需輸入卡號、有效月/年、卡片背面末三碼、手機驗證
(2)ATM櫃員機-產生虛擬帳號，由ATM轉帳
3.如您需報帳，可直接於線上繳費系統中輸入公司正確統編，或您可來信學苑告知。
4.因繳費系統產生之帳單三日後即失效，敬請特別留意，如有任何問題，請來信或來電與學苑聯絡。
5.公司報名作業，如無法於本繳費系統作業者，再來信或來電本學苑洽詢。

學苑信箱：bioschool@biotech-edu.com 學苑電話：02-2545-9721

【大嶼填海 為誰而建】
【漠視民意 事倍功半】

<對「明日大嶼」計劃之聲明>
(Please scroll down for English Version)

特首林鄭月娥在剛推出的2018年施政報告中，提出「明日大嶼」計劃，目標在東大嶼填海1700公頃，建造多個人工島。作為建築、測量、都市規劃及園境界別的選委代表，我們對推出的目的、規模、程序及模式均有所保留：

【供過於求，為誰而建】
根據政府統計處推算，香港人口於2043年達至高峰，比現在增長88萬，之後便會回落。但未計現正進行的土地房屋發展和現有閒置的房屋資源，東大嶼填海後便可供110萬人居住，為何要提供過剩的供應?

如此龐大計劃，卻沒有交代規劃願景及土地分布等重要考慮，亦沒有交代填海選址及規模的理據。特首亦明言，此計劃是要「大嶼山會成為通往世界和連接其他大灣區城市的『雙門戶』」，這不禁令人擔心，新造的土地未必能聚焦解決香港的住屋問題。

【漠視民意，無視更佳選項】
土地大辯論剛結束並正進行歸納，眾多專業團體和市民提出了大量寶貴及可行的意見，例如：棕地、軍事用地、私人遊樂場地契約用地、閒置政府地、近岸填海等選項。可惜，在土地專責小組報告未出爐前，特首突然急於推出如此大規模的填海計劃，無視整個土地諮詢，視民意如無物。而且比起大規模填海，這些選項成本較低、技術要求較低、對環境影響也較小，大規模填海是捨易取難，未有充分考慮專業意見。

【不符成本效益】
當提及填海的開支，特首輕描淡寫地說「四五千億走唔甩」。但不少工程專家認為，若計算連接的道路和鐵路，加上近年基建超支的趨勢，保守估計亦要一萬億，大約是香港外匯儲備的一半。若工程期間遇到不可預期的情況，如早前港珠澳大橋人工島移位之類，開支更會進一步飆升。當然，一萬億是否合乎成本效益，要看有否其他可達至同樣目的，但成本較低的選項。而在土地供應問題上，明顯有不少成本低得多的選擇，如收回粉嶺高爾夫球場、收回棕地等。

【合理分配，按步推展】
土地和房屋問題可分短、中、長三階段處理，因而直接影響儲備的分配。在填海的開支上，若單項投放一萬億而忽略了短中期房屋措施的資金投入，恐怕顧此失彼，未能達到成果效益的社會平衡，恐陷頭重腳輕寸步難行的困境。

【天人共存，敬畏自然】
超強颱風山竹吹襲香港，市面一片狼藉，情景還歷歷在目。當大眾開始感受到全球暖化所帶來的天然災害，大規模填海是反其道而行，因其耗能大、碳排放極高，對環境影響也是不可逆轉的。雖然特首說「氣象風險可管理」，但大自然的力量並不是人類可以匹敵的。加上如此大規模的填海，需要運用大量海砂，對填海的海域和海砂的出產地造成嚴重生態災難。其實造地應以順應大自然的方式，並考慮以人居、環境互相配合的新式設計，而非因循上世紀「新市鎮」的發展模式。就算填海是不可避免，亦可以推進式堤岸及分散式堆填等方法，在增加土地的同時產生宜居及保育沿岸生態系統，相對大規模的填海工程更能抵禦氣候變化的環境改變。

【總結】
我們作為建築師、測量師、規劃師、園境師，一向關心香港的土地和房屋問題，亦明白到這些問題的急切性。但「明日大嶼」計劃不但不能解決問題，更會引發很多不能逆轉的影響。

在過去五個月，無論官方的專家小組，或者民間研究組織，在土地諮詢過程中提出了很多優秀的方案。所以，我們呼籲林鄭月娥特首，為香港福祉，為了我們的下一代，暫停「明日大嶼」計劃，重新找出一個有利香港未來的土地發展方案，讓市民共同參與，為未來重燃希望。

<建築、測量、都市規劃及園境界別選委>：
陳彥璘 蔣偉騏 黎可頴 林穎茵 陳潔華
林芷筠 柳凱瑩 關兆倫 鄭炳鴻 敖鋅琦
黎永鋒 黃智鈞 司馬文 陳元敬 高嘉雲
劉紹禧 汪整樂 陳堯坤 雷雯

【Lantau Tomorrow - Who is it for ?】


In the 2018 Policy Address, Chief Executive Mrs. Carrie Lam announced the “Lantau Tomorrow Vision” which targets to construct artificial islands with a total area of about 1700 hectares through massive land reclamation. As Election Committee members of the Architectural, Surveying, Planning and Landscape Subsector, we have reservations on the objective, scale and procedures of the proposal:

【Oversupply of land, who is it for ?】
According to the projection of the Census and Statistics Department, population of Hong Kong will reach its peak at 2043 which means there will be an increase of 880,000 people compared to the current population. Population will then decrease gradually. If we disregard the current land and housing development and vacant residential units, the proposed artificial islands alone can accommodate 1,100,000 people. Why do we have to create more supply than demand?

Important information like planning visions and land use plan was not announced, justification of reclamation scale and site selection was also absent. This is unusual and far from satisfaction for such a massive development proposal. The CE claimed that the proposal is for “making Lantau a “Double Gateway” to the world and other Greater Bay Area cities.” This makes people speculate whether the land created will be for solving housing problem in Hong Kong?

【Public Opinion Ignored】
The public consultation on land supply has just completed and the Task Force on Land Supply has not concluded the public opinions. During the consultation process, a lot of ideas were discussed and submitted. The feasible land supply options include: brownfield sites, military sites, sites under private recreational leases, vacant government land and near-shore reclamation. Surprisingly, the CE announced the massive reclamation proposal before the report of the Land Supply Taskforce, without paying respect to the consultation and all public opinions collected. Moreover, comparing to massive reclamation, the options raised in the consultation process cost less, face less technical difficulties and have less impact to the environment. Professional knowledge is apparently not thoroughly considered in the proposal.

【Not Cost Efficient】
The CE mentioned the cost of reclamation will be “roughly 4-5 hundred billions”. However, engineering experts estimated that, including all the connecting roads and railways with consideration of recent trend of infrastructure over budget, the cost of constructing the artificial islands will be at least a thousand billions ---- this will be equivalent to half of Hong Kong’s foreign currency reserve. If unforeseen conditions were encountered during construction, such as drifting of artificial island in the Hong Kong–Zhuhai–Macau Bridge construction, the cost will be further soared. When we assess whether a project is cost efficient, we will try to see whether there is any lower cost alternatives that can achieve the same objective. The one-thousand-billion artificial islands are obviously not cost efficient as there are other options that cost a lot less such as developing the Fanling golf course and developing brownfield sites in the N.T.

【Balanced Resources Allocation】
Land and housing problems need to be solved in 3 stages: short-term, medium-term and long-term. Resources have to be allocated appropriately to all stages in order to have a coherent result. If a thousand billions were invested in a single long-term project, the resources for short-term and medium-term solutions will inevitably be limited. Such resource imbalance cannot create the desired social return.

【Living with Natural Harmony】
Our memory is fresh with the destruction of Typhoon Mangkhut which we experience the consequence of global warming. Massive reclamation is a bad response to climate change. It will spend massive energy, vast amount of carbon emission and it will bring irreversible impact to the ecosystem. Although our CE claimed that “climate risks can be mitigated”, natural force is nothing human being can be compared. In addition, this scale of massive reclamation will need incredible amount of marine sand. It will bring forth ecological disaster to the reclamation area as well as the marine sand mining area. For sustainable development, land supply shall adopt methods that are harmonious with the environment and design that balance between human habitat and nature. Just following the “New Town Development” mode that was used a century ago is not going to be a good solution. Even reclamation is inevitable, progressive reclamation along the coast shall be considered first which is more friendly to the marine ecology and less impactful to climate change.

【Conclusion】
As Architects, Surveyors, Planners and Landscape Architects, we are deeply concerned with the land and housing problems in Hong Kong. We also understand this is an urgent issue that we have to face and tackle immediately. However, we doubt whether the “Lantau Tomorrow Vision” can solve the problem, indeed, we worry that it will even bring us irreversible impacts.

In the past 5 months during the public land consultation, the official land task force and many civil research groups have proposed many feasible solutions for land supply. We urge the CE, for the sake of sustainable development in Hong Kong and for our generations to come, suspend the “Lantau Tomorrow Vision” proposal. Let’s work together with the people for a better Hong Kong and bring hopes to our future.

：
Chan Yin Lun Jeremy, Tseung Wai Ki, Lai Ho Wing, Lam Wing Yan, Chan Kit Wah Eva, Lam Tsz Kwan, Lau Hoi Ying, Kwan Siu Lun, Chang Ping Hung, Ngo Tsz Kei, Lai Wing Fung, Wong Chi Kwan, Paul Zimmerman, Chan Yuen King Paul, Gavin Coates, Lau Siu Hay Derek, Wong Ching Lok Christopher, Chan Yiu Kwan, Lui Man

說實在話，這帥呆了！
最近幾天已經被瘋狂洗版中。
如果，
如果，
如果你還沒點開來看的話，動動手指感受一下如何呢？
快看拉～～～

#nike ＃kissmyairs #scientist

YUEN HSIEH與HYPEBEAST合作找來李宇春為NIKE AIR MAX DAY所創作的TIME TRAVEL EXPERIMENT PROJECT影片

時光旅行曾被認為是個不可能的實驗計劃 , 人無法前往過去或未來去改變什麼。

2017年一群由四谷機械( SHIYA ROBOTIC )的科學家與研究員在秘密倉庫的超能力研究所 , 在80年代這群科學家藉由人體實驗刺激孩童的大腦 , 觸發出待開發的大腦潛能 , 使這群孩子擁有超越人類的力量 。編號CRL1003則參與超能力研究所裡的TIME TRAVEL實驗計劃 , 編號CRL1003是機動部隊隊長將帶領兩位成員前往十年後的未來。TIME TRAVEL實驗計劃只能去到未來15分鐘便會回到現實 。
而在2027由於經濟蕭條使得四谷機械的超能力研究所被強制關閉 ,
此時2027的CRL1003依舊堅持自己的理想持續創變 。
CRL1003與兩位機動部隊來到2027年並發現當初超能力研究所的未公開機密檔案 , 進而想要找出當初找她參與TIME TRAVEL實驗計劃的原因 , 在散落的文件中 , 她找到了研究員VOA1988的報告書發現了她料不想到的真相。
於是她隨著爆炸聲 , 走到了2027年的地下社會 , 遇見了MEW2911與SRD6469並在人群中看到研究員VOA1988與貌似自己的身影 , 當她想穿越人群去找尋那個自己時 , TIME TRAVEL15分鐘時間已到並回到2017年。
Time travel used to assumed an impossible experiment project based on the general cognition that human beings were unable to change anything in the past neither the future by moving onwards or backwards in time.
A group of scientists and researchers from Shiya Robotic.Ltd has been working on clinical trials since the 80s by stimulating children’s brains in a superpower lab hidden in a secret warehouse. The achievements of triggering brain potential grant these children outstanding power beyond human nature. In 2017, CRL1003, the captain of the mobile force, is assigned to lead two Tactical Unit members to travel toward the 10-year-after future. Each journey only lasts for 15 minutes and would be back to the present.
While travelling in 2027, CRL1003 and her two members find out the unreleased confidential documents of their lab. She tries to dig out the answer why the lab appointed her to join this project. By going over a mess of scattered documents, the report of Researcher VOA1988 eventually revealed the expected truth. CRL1003 follows (the) a explosion sound (, walking) and it leads her to a underground society in 2027. When she meets MEW2911 and SRD6469, she saw Researcher VOA1988 who looks just like her in the crowd. When she tries to walk pass the crowd looking for VOA1988, her 15-minute journey has ended and back to 2017.

服裝 COSTUME DESIGN ｜ Guerrilla-Group.co

造型 HAIR AND MAKE UP｜ Flux Réel Hair Boutique

平面攝影 BEHIND THE SCENE PHOTOGRAPHY｜ 低俗連載 teizokurensai

配樂 MUSIC｜ fish.the