2021/4/26(一) ~ 2021/4/29(四)【臨床試驗線上系列】 臨床試驗概論及重要參與角色 ★第三梯次熱烈報名中★
主辦單位:台灣光鹽生物科技學苑
課程地點:線上同步遠距教學(Webinar)
課程日期:110年4月26日 (一) 至110年4月29日 (四) 每日 19:30至21:20 (18:30 開始報到)
*第三梯次因應學員課程回饋,將課程天數縮短、時數增長,以便提升學習成效 (第三梯次與前兩梯次課程內容及課程總時數相同,敬請放心)
授課師資:江君敏 資深臨床試驗顧問 台灣光鹽生物科技學苑
【授課大綱】
110年4月26日(ㄧ) 19:30至21:20
(一)【新藥開發及臨床試驗概論 Introduction to Drug Development and Clinical Trial 】
A. Introduction to Drug Development and Clinical Trial
1.新藥臨床試驗申請IND
2.新藥查驗登記申請 NDA
3.臨床試驗階段 Phases of Clinical Trials
4.臨床試驗設計Clinical Trial Design
B. Organizational Structure of Clinical Trial Site
試驗主持人/試驗機構職責Responsibility of Investigator/Site
C. Learning Check
110年4月27日(二) 19:30至21:20
(二) 【臨床試驗委託者/受託研究機構的執行架構及角色 Sponsor/CRO Organizational Structure and Professions in Clinical Trial】
A. 委託者/受託研究機構Responsibility of Sponsor/CRO
(1.)臨床試驗執行Clinical Operations
(2.)資料管理Data Management
(3.)業務開發Business Development
(4.)品質管理Quality Assurance
(5.)藥品安全監視Pharmacovigilance
(6.)藥事法規Regulatory Affairs
(7.)醫藥寫作Medical Writing
(8.)醫藥事務Medical Affairs
B. Learning Check
110年4月28日(三) 19:30至21:20
(三)【臨床試驗參與角色的規範依據ICH-E 】
A. 臨床試驗規範依據ICH-E
1.藥物主動監視E2A-E2F
2.臨床試驗報告E3
3.優良臨床試驗規範E6
4.臨床試驗一般考慮要點E8
5.臨床試驗統計E9
B. Learning Check
110年4月29日(四) 19:30至21:20
(四)【臨床試驗階段 & 品質管理 Phases of Clinical Trial & Quality Management】
A.臨床試驗啟動階段 Pre-trial Activities
(1.) 可行性評估Feasibility
(2.) 試驗機構評選Site Selection
(3.) 送審Submission
2. 監測Monitoring
3. 結案Close-out
B. 品質管理 Quality Management
1. 稽核Audit
2. 查核Inspection
3. 根源分析及矯正預防措施Root Cause Analysis & CAPA
C. Learning Check
線上報名網址 https://forms.gle/o6uvY4QGR7gQ85kw7
學員對象(本課程為基礎課程,符合下列其中一項均可):
(1) 大專以上具理工或生醫背景,對臨床試驗工作有興趣者
(2) 臨床試驗相關產業之新進人員
課程費用:
每人單堂: 800元 系列課程(共4堂課程): 2,800元 (原價4,000元)
在學學生每人: 600元 系列課程(共4堂課程): 2,000元 (原價3,000元)
(在學學生報名時,需拍攝學生證或相關在學證明文件email至學苑)
*<臨床試驗概論及重要參與角色>為完整系列課程,需全程參與四堂課程,使得核發電子版結業證書
同時也有5部Youtube影片,追蹤數超過567的網紅rmarpaofficial,也在其Youtube影片中提到,Saint Padre Pio National Shrine in the Philippines TRAVEL VLOG#06 Bago ang lahat nais ko lang magpasalamat sa buong taong nakalipas nong 2017. The ...
site structure 在 Facebook 的最佳解答
【🇩🇪🏞德國情景】♩. ♪ 德國的維希林城堡 (Vischering Castle)
#長得好像模型

中世纪的維希林城堡(Burg Vischering)被護城河所環繞,是威斯特伐利亞最古老的城堡,位於明斯特(Münster)以南30公里處。
Vischering Castle (German: Burg Vischering) in Lüdinghausen, North Rhine-Westphalia is the most typical moated castle in the Münster (region) of Germany. This region has one of the highest German concentrations of castles, palaces and fortifications, Lüdinghausen having three by itself. The castle consists of outer defensive courtyard, defensive gateways, moat, drawbridge, main building and chapel. The sandstone walls, the red tile roofs as well as their reflection in the moat provide many harmonious views from the wooded surroundings.
Vischering Castle was built by Bischop Gerhard von der Mark to counter the second castle built by the Von Lüdinghausen family. It became the seat of the Droste zu Vischering Family. Droste is the local title for the hereditary noble administrators serving the Bishops of Münster. The moat is constantly replenished by a side-arm of the River Stever. The outer defensive courtyard contains the business and farm buildings. The main building is a horseshoe-shaped three-story structure with heavy outer wall. Its inner courtyard is closed off by the chapel and a lower defense wall. A castle keep is missing, having been removed during Renaissance renovations. Fire destroyed the castle in 1521. Rebuilding took place on the existing foundation. Windows and the addition of a large bay made the castle more liveable but diminished its defensive character. The whole site however retains the character of a feudal age moated castle. Damage from air attack during World War II was minor.
Vischering Castle houses the Münsterlandmuseum, an exhibit on knighthood for children, as well as a cafe-restaurant. It serves as a cultural center for Kreis Coesfeld. Visiting hours are provided in the first link below. Viewing the outside is possible at all times. The second link provides a more detailed chronology of the castle in German .
site structure 在 Focus Taiwan Facebook 的精選貼文
A construction site in Kaohsiung was ordered Thursday by the city government to cease operations pending an investigation after a 10-ton rebar structure collapsed, killing one worker and injuring four others.
https://focustaiwan.tw/society/202103040011
site structure 在 rmarpaofficial Youtube 的最佳貼文
Saint Padre Pio National Shrine in the Philippines
TRAVEL VLOG#06
Bago ang lahat nais ko lang magpasalamat sa buong taong nakalipas nong 2017.
The National Shrine and Parish of St. Padre Pio, commonly known as Padre Pio Shrine, is a parish church and pilgrimage site situated at Brgy. San Pedro, Santo Tomas, Batangas, Philippines. Administered by the Roman Catholic Archdiocese of Lipa, the church was designated as a National Shrine by the Catholic Bishops' Conference of the Philippines making it the first in the province of Batangas and in the CALABARZON Region. It became one of the venues for the 4th World Apostolic Congress of Mercy held in the Philippines on 16–20 January 2017.
The structure of the main church is made mostly of indigenous materials such as wood, stone, bamboo, sasa or nipa leaves and sawali or woven bamboo strips. The shape of its roof resembles a salakot, a traditional Filipino hat used by farmers and fishermen in their respective agricultural activities as their protection against heat and rains. At the top of the roof stands the image of Our Lady of Mercy.
Thanks Wikipedia, the free encyclopedia Pawer!
site structure 在 鄧嘉傑 SIMON TANG Youtube 的最佳貼文
馬甲線和腹肌入門計劃
達致塑形的兩大要點:1. 通過肌肉訓練保持線條;2. 通過有氧訓練減掉脂肪。適合追求線條美的女生和男生。
建議計劃:
十分鐘熱身
各等級肌肉運動計劃,每次二至四次大循環.(馬甲線和腹肌入門計劃)
有氧運動(自行選擇) 20-30分鐘
各部位伸展操
注意事項
剛開始訓練時,局部疼痛屬於正常情況,幾次訓練之後,這樣的情況就會得到緩解。
每次訓練前做好熱身,在整個訓練過程中,使用正確地呼吸方式,切勿憋氣訓練。以動作的正確、自身安全為重。
每次訓練完進行拉伸,可以緩解肌肉酸痛。
在我的個人專頁會有更詳細講解 - https://www.facebook.com/simontang131/
靚相同日常影片會在IG - https://www.instagram.com/simontang131/
Actor - 鄧嘉傑 Simon Tang, Karen Law 羅堃尉 (https://www.facebook.com/LawKwanWaiKaren)
Special Thanks - Rondey trickstation For lending site (https://www.facebook.com/trickstation/?fref=ts)
site structure 在 Doctor KONAN / 木南 Youtube 的精選貼文
東大寺 大仏殿に行った時には、ぜひ大仏の鼻の穴を通ってみてください。
◆Doctor KONAN / 木南 チャンネル登録お願いします。
http://www.youtube.com/user/Doc?sub_confirmation=1
◆Doctor KONAN / 木南 Twitter
https://twitter.com/Doctor_KONAN
自己紹介
こんにちは。ガジェット系のレビューを中心に、パソコン、スマートフォン関係の動画を上げています。
できるかぎり、毎日動画を作っていく予定です。
ヒーローショーやエンタメ系の動画もアップします。
楽しいことは、みんなでシェアしたいと思います。
撮影機材
カメラ:CANON Ivis M52
マイク:SONY ECM PCV-80U
東大寺盧舎那仏像(とうだいじるしゃなぶつぞう)は、東大寺大仏殿(金堂)の本尊である仏像(大仏)。一般に奈良の大仏(ならのだいぶつ)として知られる。
聖武天皇の発願で天平17年(745年)に制作が開始され、天平勝宝4年(752年)に開眼供養会(かいげんくようえ、魂入れの儀式)が行われた。その後、中世、近世に焼損したため大部分が補作されており、当初に制作された部分で現在まで残るのはごく一部である。 「銅造盧舎那仏坐像」の名で彫刻部門の国宝に指定されている。
正式には大仏は「盧舎那仏坐像」、大仏殿は「金堂」というが、本項では以下「大仏」、「大仏殿」とする。また、文中の( )の年はユリウス暦、月日は全て和暦、宣明暦の長暦による。
Nara's premier attraction is Todaiji Temple and its Daibutsu (Great Buddha). When Emperor Shomu ordered construction of both the temple and Diabutsu back in the mid-700s, he intended to make Todaiji the headquarters of all Buddhist temples in the land. As part of his lanes for a Buddhist utopia, he commissioned work for this huge bronze statue of Buddha; it took eight casting to compete this remarkable work of art, which remains the largest bronze statue of Buddha in Japan. At a height of more than feet, the Daibutsu is made 427 tons of bronze. However, thanks t o Japan's frequent natural calamities, the Buddha of today isn't quite what it used to be.
The wooden structure housing the Great Buddha, called Daibutsuden, was destroyed several times through the centuries; the present structure dates from 1709. It's the largest wooden structure in the world but is only two-thirds its original size.
Behind the statue, is a huge wooden column with a small hole as the same size as Buddha's nostrils. in it near the ground. According to popular belief, if you can manage to crawl through this opening, you'll be sure to reach enlightenment.