【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局
🌍此次學苑特別推出國際線上同步遠距課程,並與德國講師合作,提供學員最新的國際臨床試驗實務課程!
此次課程為系列課程,首堂為”歐洲臨床試驗申請策略與佈局”。對於想往歐洲發展、合作或與歐洲從事臨床試驗的相關公司廠商有很大的幫助!
Date:
Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
Location:Online Webinar Training
Instructor:Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】
Part 1 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
A. Europe – One Union with differences
B. European Clinical Trial Directive
1.Role of national competent authorities
2.Role of ethics committees (central / local)
3.Role of investigator
4.Role of sponsor
5.Role of EMA
C. Planning clinical trials in Europe
1.Analysis of product
a.Indication
b.Patient group
2.Analysis of end points
3 .Analysis of protocol
4.Preparing feasibility
5.Choosing Key Opinion Leaders
6.Sponsor or IIT?
7.Similar studies already running?
Part 2 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
A. Applying clinical trial
1.Collecting information you need
2.Establishing study team
B. Required entry into EudraCT
C. Required approval from national HAs and ethics
D. Required fulfilment of national data protection laws
E. Considerations
1.Doing it by yourselves
2.Contracting CRO
3.Auditing
F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments
G. Final presentation of study reports
Online Course Fees include 2 Webinars, 90 minutes each:
Special Price $160 USD per Person; Original Price $180 USD
(*1) Certificate of Attendance will be issued only if participants attend both part 1 & 2 webinar
(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment
Register here 👉 https://forms.gle/Kj9yMVynsq7yzSzs8
Organizer:ARC-TRAICOA
Co-Organizer:Salt and Light Institute
【Target Audience】
(1.) Anyone who is interested in clinical trials in Europe
(2.) Anyone who has experience in working in clinical trials related field such as PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA, etc)
【Instructor CV】
Anika Staack
Current Position:
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker
Previous Experience:
EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
Senior Drug Safety Manager at ICON
Lead Site Management Associate at PRA
Clinical Research Associate at SKM Oncology
Expertise:
Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD
Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality
Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports
Authorization process: PSMF, RMP & PSUR Writing, answering authority requests, Risk Management, overseeing product life-cycle
Education Background:
Master of Science (Biology)
Email: bioschool@biotech-edu.com Tel: (+886) 02-2545-9721 ext.18
同時也有8部Youtube影片,追蹤數超過21萬的網紅Ghib Ojisan,也在其Youtube影片中提到,Have you ever heard of Jurassic Mile? It's an attraction that recently opened in Singapore near the Changi Airport. Locals flocked there to check out ...
c# life cycle 在 觀玲的女力強化研究所 Facebook 的最佳解答
{觀玲❤️工作}Enjoy Your Life!動起來!「LOOKin美人生活時尚講座」來囉!不運動的我(伸展應該不算吧)居然來到「Space Cycle」教大家動起來!?不不不~動起來的是瑜伽老師!我跟玉兔是要來分享變美好物啦!
首先分享GEM BEE貞蜜,「神奇蜂膠百解膏」我非常喜歡,小小一瓶功效多多,可以潤澤肌膚、舒緩、修護還能提振精神,萬用膏來著,主要成分為「多元蜂萃精華(蜂膠、蜂蜜、蜂王乳)」,還有薄荷、尤加利、天竺葵等六種精油,所以除了提神,還能按摩肩頸,塗抹蚊蟲藥傷,塗抹乾燥敏弱脫皮部位,這瓶成為我的心頭好!
GEM BEE貞蜜還有「私密處潔護慕斯」,私密處清潔有多重要應該不用多說,它也含有「多元蜂萃精華(蜂膠、蜂蜜、蜂王乳)」,多奢華呀!還有保濕、舒敏、修護、提升免疫力、改善暗沉等草本成分,再以「水解酵母蛋白」及益生菌生態養分,來維持私密處好的環境,蜂膠基本上也能抑菌,害羞看婦產科嗎?拜託大家私密處清潔一定要用!
另外還有兩款女性、男性專用的保健食品,提升女性魅力的蜂王乳,加強男性自信的南非醉茄,再添加馬卡、透納草等草本成分改善體質,調節生理機能,還有色胺酸幫助睡眠!感覺吃B群還是不給力的現代男女們,也可以試試看草本配方,找回幸福力喔!
「baby fish」要跟大家分享的是體態調控及「地表最強」吃的保養品,「23in XR」熱銷四年,除了體態調控、調整新陳代謝,還有針對愛吃澱粉、糖分族群設計的專利配方,針對不運動族群還能提升燃燒分解,再幫貪吃鬼抑制食欲,這款食品級膠囊的油切力及吸油力連專業營養師也推薦。
「法國頂規胜太級微囊膠原蛋白粉」&「維他命C+玻尿酸膠囊」採分食概念加強美顏,先補充1000道爾頓小分子膠原蛋白,再加強美國卡姆果維他命C,促進膠原蛋白增生,再以玻尿酸來膨潤肌底,還有德國賽洛美加強肌膚屏障力,空腹補充,雙管齊下,每一天都能感受到肌膚的改變。(吃的美容品,我可是從30歲開始就沒有停止過)
今天除了跟玉兔還有大家開心大聊,聊到工作人員一直轉圈圈外,攝影大哥還幫我們拍了很多可愛的照片。話說瑜伽真的是很優質的運動,來這裡運動的人也很多,然後除了我之外,大家都被通知穿運動服包括玉兔🤣🤣🤣。
【LOOKin】美人時髦話題網。看見女性新時尚 貞蜜 GEM BEE 澄杏醫藥 #23inXR #SpaceCycle
c# life cycle 在 歌c拉。3年抱3。1湊3 Facebook 的最佳解答
#STEAM好玩意探索科學奧秘 #tinkererSTEAMbox #一期免費優惠
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1. 咁漫長嘅疫情假期最啱就係有搞作,STEAM box 啱晒!😁
2. 媽媽👩🏾覺得Tinkerer嘅DIY科學百寶盒非常富趣味性同埋啓發性🤩
3. 佢哋近排有 #優惠 ,購買12個月box,就有一期免費!🤩
所以一定要再同大家分享!🙂
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Tinkerer Box 📦 適合3-12歲小朋友玩 ,分別有3個level:
Wonder level (3-5歲)
Odyssey level (6-8歲)
Explore level (9-12歲)
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而我哋今次收到2個box,但係首先介紹咗非常適合我哋4歲妹妹👧🏻玩嘅Wonder Level box「 #lifecycle生命週期 」📦,妹妹👧🏻見到有啱佢玩嘅box開心到飛起!😆
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介紹非常可愛嘅 「life cycle 生命週期」主角之前,再次推介box內嘅小雜誌📙,每次解說唔同嘅STEAM小知識,真係good good good👍🏻👍🏻👍🏻,佢哋3個👧🏻🧒🏻👦🏻次次打開盒子第一件事一定係成本睇晒至研究盒入面嘅主角嘅!😆😂
今次Wonder Level 嘅「life cycle 生命週期」有3個項目俾佢哋自己去完成。
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3個人仔👦🏻🧒🏻👧🏻又一次打開說明書自己一步一步跟住指示做,而大哥哥更加充當小老師,解釋俾弟弟妹妹聽需要點樣做!第一個要做嘅係布偶小毛蟲🐛、第二個係小狐狸🦊透視鏡、第三個就係小蝴蝶🦋手帶,製作過程中3個👧🏻👦🏻🧒🏻繼續合作無間😊完成作品,非常開心嘅假期活動呀 😌!
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另外,從製作過程中佢哋學識蝴蝶係完全變態嘅昆蟲,佢哋生命中 有卵、幼蟲、蛹及成蟲四個階段。
因為呢種生存方式有更強競爭性,例如幼蟲和成蟲間完全不同嘅特性。我哋可以睇到蝴蝶🦋經過不同嘅蛻變,「卵-幼蟲-蛹-成蟲」完成佢嘅生命週期。 👍🏻👍🏻👍🏻😎
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Tinkerer Box
每月以hkd$171.00起訂購,更會直接寄到屋企,完全可以足不出戶都感受到 STEAM 嘅奧妙咖!🤩
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🛍🛍依家購買12個月計劃, 喺order summary 位置 #輸入優惠碼 「 FREE50 」#第一期免費 ,快啲去連結🔗訂購啦!🛍🤩
https://www.tinkererbox.com/
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LIKE 👍🏻同追蹤 定
歌c拉。3年抱3。1湊3
www.instagram.com/threekids.gloria
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歌c拉媽媽👩🏽稍後將會有更多不同類型嘅資訊分享,同埋好快又會有禮物🎁 giveaway咖啦!😊
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之前分享tinkerer box 嘅 post👇🏻😁
http://bit.ly/2WdApIA
http://bit.ly/3d0tWqi
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#全職媽媽 #香港媽媽 #Tinkerer #STEAMbox #三年抱三 #親子 #coollovehk #happybloghk #香港開箱 #科學知識 #tinkererbox #tinkerersteambox #steambox #steam #科學玩具 #香港人齊防疫齊抗疫
#wonder #odyssey #explore #planelauncher #lifecycle
c# life cycle 在 Ghib Ojisan Youtube 的精選貼文
Have you ever heard of Jurassic Mile? It's an attraction that recently opened in Singapore near the Changi Airport. Locals flocked there to check out the life-size dinosaurs. I was never really excited about this new thing but there must be a reason why so many Singaporeans visit there. Is it really worth visiting? Join me as my friend James and I cycle to the new Jurassic Mile.
Follow me on social medias!
?Instagram https://www.instagram.com/ghibli_ojisan/
?Twitter https://twitter.com/ghibli_ojisan
?Subscribe: http://urx3.nu/HTUJ
?Watch - Funniest Video I’ve Made:https://youtu.be/qmqJ5A4DaOI
?Merch Links:
SE Asia | https://ghib-ojisan.secure-decoration.com/shop/category/T-Shirt?c=2731898
USA & EU | https://teespring.com/stores/ghib-ojisan
Japan | https://suzuri.jp/ghib-ojisan
Business Enquiries
✉️[email protected]
You are welcome to send fan mails but I may not be able to respond to all of them. But I immensely appreciate your support. Thank you!
#Singapore #JurassicMile #Changi

c# life cycle 在 SHIBA and KOJI Youtube 的最佳貼文
"Bike Trip" Its was our dream.
Driving motorcycle on the off-road to
the place that we have never seen.
Unforgettable Beautiful nature in Ladakh.
That was beyond our imagination easily.
We can’t describe how it was!
But most beautiful thing we’ve seen was people
who live with the harshness of nature in
the super high attitude mountain.
It shows us how life is good only just putting
a smile on our face, wherever we are.
「ラダックバイク旅」
澄み渡る青空
風と共に揺れる旗
“今”を生きる人々
一言では言い表せないその魅力は、
自分達の心をより強く
そして、確信に変えてくれた。
Life is good.
______________________________________________________
“Ordinary is Extraordinary. “
-特別なことは、当たり前の毎日の中に-
「一生夢を追え、思い出は一生の宝物」
↓チャンネル登録よろしくね↓
Subscribe: https:www.youtube.com/c/shibaandkoji
______________________________________________________
Music:
"Love of Mine."
by The Hunts
______________________________________________________
Gear: Sony A7 III Tamron 28-75mm F2.8 Di III RX
Location: Leh, Photoksar, Lamayuru, Pangong lake,
Ladakh, INDIA
Date: Oct. 2019
Filmed, Photographed by SHIBA and KOJI
______________________________________________________
**FOLLOW SHIBA**
INSTA - https://www.instagram.com/nexadventure
FACE - https://www.facebook.com/shibachann
TWIT - https://twitter.com/kojiandshiba
**FOLLOW KOJI**
INSTA - https://www.instagram.com/koji_slk
FACE - https://www.facebook.com/kozzys
TWIT - https://twitter.com/kojiandshiba
#biketrip #travel #india

c# life cycle 在 Sherry Go Sharing Youtube 的最佳貼文
Sharing is caring this product suitable for mommies and ladies that love beauty products. To know more of the product can visit www.lunavie.com.
Lunavie Portable UV Sterilizer & Dryer, it is easy for travel use too. If you are bringing baby to holiday, you might want to consider this. The 3 pin plug is easy to use for household in Malaysia.
The Lunavie Portable UV Sterilizer & Dryer is a convenient sterlizing household unit. With the Phillips UV lamp, the Lunavie UV Sterilizer eliminates 99.9% of harmful bacterial and is safe to use on all of your baby’s various feeding gear while the HEPA Filter blocks up to 99.7 % of air borne dust and particles. It designed with touch screen buttons, simple to use and easy to carry everywhere.
• The direct use of 7 mirror stainless steel allows the UV to refract 360 degrees without hidden angle.
• HEPA clean filtration system resist 99.7% from outside hazardous substances.
• Low temperature drying that prolongs the life cycle of your feeding items & etc.
• Disinfection up to 99.9% of germs, bacterial, molds and viruses.
• Storage setting *activates 2 minutes UV Sterilize every 2 hours.
• Portable size gives you convenience to carry everywhere you go and more space on your countertop.
• Easy to operate with touch screen buttons.
4 Intelligent Programs to choose:
a) Auto: Option to dry and sterilise for 41 & 61 minutes.
b) Sterilize: Option to sterilise only for 11, 16 or 21 minutes.
c) Drying: Option to dry only for 41 or 51 minutes.
d) Storage: With AUTO one cycle *automatically actives 2 minutes sterilise every 2 hours for total 72 hours.
Specification
• Product Name: Portable UV Sterilizer & Dryer
• Sterilizing Power: 4W
• Dryer Power: 75W
• Voltage: 220v-240v, 50hz-60Hz
• Inner Capacity: 7L
• Net Weight: 2.02kg
• Gross Weight: 3.1kg
• Product Size: 280*280*247mm
• Warranty: 2 Year Warranty
Warranty card can be find in the box.
