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【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

有冇聽過以下呢句說話：
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噚晚就係email：「Thanks for sharing with us the draft. Just received some feedback from client……」

其實我未瞓，選擇唔覆完全係為對方好，試想像已經係夜深時份，佢send完畀我之後，算係完成咗手頭上嘅工作，如果我即刻再reply，即係佢又未收得工，香港地真係冇一份工係輕鬆。

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「係呀......呢排晚晚好夜，驚有嘢甩吖嘛，早排個市唔好，而家多返啲job，大家想做好啲，啲客都緊張過之前好多。」

我明呀，我都有呢種心態，有時覺得有job接有工返真係感恩，賺錢從來都唔容易。

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📌📍《5月35日》「庚子版」 眾籌活動
集結力量 網上演出 六四前夕 全球直播
"May 35th" Gengzi Edition - Crowd Funding
Join Forces for Global Live Online Performance on the night before June 4th.

🔇🔇「以現在的社會狀況，我們的政治氣候，我擔心這個戲未必有機會再上演﹗」導演陳曙曦說。
🔊🔊"With the forecast of the political climate now, I am very worried that this play will not be any chance to put on stage again" said Chan Chu-hei, the director.

🚨🕯️我們希望集結公民力量，
令全球所有人都可以在「六四」免費網上觀賞《5月35日》，
讓這個故事遍地開花，
讓更多人了解真相、追求公義。
🚨🕯️We target to join the force of citizen
to let us share this Online LIVE theatre production
“May 35th”globally, make this story worldwide,
and let the truth speak for itself, justice be sought after.

‼️➡️眾籌支持方法 Way of Crowdfunding：

1) 請即登入網上平台：https://goget.fund/2Wz5kO9
（暫不能用PayPal 戶口，請用"Visa/ Master" 捐款
Please DO NOT use PayPal Account, but click the icon "Visa / Master")

2) 支票捐款- 抬頭寫「六四舞台」，郵寄到
九龍旺角彌敦道618號好望角大廈8字樓（六四舞台）
By Cheque - Please make the cheque payable to "Stage 64", and mail to 8/F, Good Hope Building, 618 Nathan Road, KLN. (Stage 64)

************************************************
2019年六月，是「六四」的三十周年，六四舞台邀請了著名編劇莊梅岩創作《5月35日》。首演5場及加開的6場門票均全部售罄，一致好評，更獲本屆舞台劇獎六大提名，包括最佳劇本！經歷了大半年的社會運動，面對過暴政與暴力，「六四」對香港人多了另一重意義，在謊言與假新聞氾濫的社會，《5月35日》為悼念亦為警世！

🧐🧐為了蒐集資料，編劇莊梅岩曾到訪內地訪問當年「難屬」，亦因此被神秘人「探訪」和「關注」，令她質疑香港的創作自由可能已經岌岌可危。

🤐🤐眼下的暴政和警暴，「廿三條立法」如箭在弦，六四舞台在香港再有生存的空間嗎？

🤬🤬當網絡上充斥假新聞，官方又不斷篡改歷史事件，究竟「六四屠城」和「反送中運動」在不久的將來會變成什麼樣的故事呢？

我們不知道答案，但只要有機會，我們仍然要演下去﹗因此當社會運動仍在激烈抗爭之際，六四舞台就馬上籌組了《5月35日》（庚子版）。

📆根據中國歷法，2020年是庚子年；翻開中國歷史，庚子年往往是浩劫之年。香港經歷多個月的社會運動，「六四」對步入庚子年的香港人有何意義？六四舞台今年誠邀著名導演陳曙曦，連同全新班底，重新創作《5月35日》 的「庚子版」。

😷😷鑑於疫情持續，政府下令關閉全港劇院，令原訂5月在香港藝術中心的舞台演出被迫取消，劇團為堅守信念，破天荒決定把這個震撼人心的六四故事以網上直播形式，於2020年六四前夕向全球人士同步免費播放（粵語演出，附中英文字幕），並於6月4日全日24小時在網上分享。其錄像版本亦將會製作成電影影片，把演出搬上大銀幕，讓更多人了解真相、追求公義。🖐️🖐️🖐️🖐️🖐️

June 2019 marked the 30th anniversary of the “June Fourth Incident”. Local art group Stage 64 joined hands with renowned playwright Candace Chong Mui-ngam to create May 35th. The first 5 premieres as well as the 6 additional shows were all sold out with great acclaims, followed by 6 nominations in the subsequent Hong Kong Drama Awards, including Best Script!

The social movement in the past 6 months has made Hong Kongers no strangers to tyranny and brutality, and has transcended the meaning of "June Fourth" within us. Especially when we are living in a world full of lies and fake news, the play "May 35th" is for mourning and also a warning!

🧐🧐Candance Chong Mui-ngam has visited the Mainland for screenplay research. There she met up with some interviewees, whose family members were June Fourth Massacre victims. It turned out some mysterious figures paid her a "visit" in return with "unexpected concern". She couldn't help but worrying: Is the creative freedom deprived even in Hong Kong?

🤐🤐Witnessing the escalating brutality against protestors, the eagerness of enacting Basic Law Article 23, how much longer can a play like "May 35th" be staged in Hong Kong?

🤬🤬Worse still are the tremendous fake news on the Internet and the tampering with history. Can you imagine how "June Fourth Incident" and "Anti-Extradition Bill Protest" will be interpreted in the near future?

We have no clue, but! As long as we have this opportunity to express, we will go on. Even when the protest across the city was still intense, Stage 64 started to plan for another "May 35th" , the Gengzi Edition.

📆In the Lunar calender, 2020 is called the year of the Gengzi. Historically speaking, the year of the Gengzi were always catastrophic. After months of social unrest, Stage 64 invited prominent director Chan Chu-hei, to re-create "May 35th" into Gengzi Edition with new cast and crew.

😷😷Then comes the Coronavirus pandemic and the compulsory closure of theatres by the Government. That left us no choice but to cancel the "May 35th" performance, which was originally scheduled to stage at Arts Centre in May. But what if we adhere to our beliefs? Here comes the bold decision-\-\to live stream this astonishing show, globally and for free on the night before June 4th, 2020 (Presented in Cantonese, with Chinese and English subtitles). The live version will then be shared online throughout the day on June 4th. What’s more? The performance will be filmed separately and released in cinemas. Let the truth speak for itself, justice be sought after. 🖐️🖐️🖐️🖐️✋

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

💰籌款目標💰
35萬，但50萬能讓我們做得更多
Crowding Funding Goal
HK$350,000, but we can go further if we get HK$500,000.

🆘製作一齣舞台劇的基本成本相當高，一般要靠數千張數百元的門票收入才能維持收支平衡。在疫情下失去劇院，沒有門票收入，加上題材敏感，《5月35日》要獲得商業贊助機會是「零」。因此，我們只能靠公民發揮力量，解囊相助，協助我們把舞台劇作全球網上直播及製成影片，把故事帶到更遠。

🆘A stage production costs a lot. Generally we need to sell several thousands of tickets to break-even. Considering the circumstances of coronavirus pandemic, we can no longer perform in theatres and therefore no income from box office. In addition, due to the sensitivity of the theme / topic, in spite of our best endeavours, it is impossible for May 35th (Gengzi Edition) to receive any commercial sponsorship. What we need now is everyone exert their power and generosity, elevating May 35th (Gengzi Edition) to online streaming platform and even to cinemas, bringing the story to the rest of the world.

These are pretty much all my affordable/drugstore favorites(except the tinted hydrator, but honestly it wore beautifully today along with revlon concealer!! 8hrs+) I love this glam so so much that I definitely will wear again! Which look is your favorite? Let me know some of your drugstore faves too!

Please don't forget to subscribe :)
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http://instagram.com/tesschung
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Full product list
Wet n Wild Color Icon 5-Pan Palette- Go Commando $3.39(target)
Look 1
rimmel scandal eyeliner - green
colourpop creme gel liner - get paid
essence lash princess (green tube)
Look 2
colourpop creme gel liner - get paid
essence lash princess (green tube)
Look 3
essence lash princess (green tube)
*rude cosmetics Teeny Weeny Micro Eyebrow Pencil - Black Brown $5.50
(mark * as PR)

On my face
pixi glow mist $11 - $15 (if it's on sale)
wet n wild tinted hydrator skin veil - fair $3.99
revlon candid concealer - 05 fair $5.69
essence banana brighten up powder $4.99
physicians formula butter collection x weylie hoang $14.99
colourpop lippie pencil - little one $3 - $6 (BOGO sale)
colourpop ultra blotted lip - zuma $3.50 (ulta) $8

age 35
skin type : dry sensitive
skin tone: fair-light neutral leaning warm undertone


FTC: this video is not sponsored!

Music
HONÜ - Rainbow Falls - https://thmatc.co/?l=F8C27157
Mariami - Gates - https://thmatc.co/?l=727C9C44
HONÜ - Summer Sunshine - https://thmatc.co/?l=906E9C40

Hitman (2016)
You can buy the game at https://store.epicgames.com/legendauser/hitman

Bonus Mission
- Holiday Hoarders
- The Icon
- Landslide
- A House Built on Sand

HITMAN™ is a third-person stealth video game in which players take control of Agent 47, a genetically enhanced assassin, traveling to international locations and eliminating contracted targets. As in other games in the Hitman series, players are given a large amount of room for creativity in approaching their assassinations. For instance, players may utilize long-ranged rifles to snipe a target from a long distance, or they may decide to assassinate the target at close range by using blade weapons or garrote wire. Players can use explosives or disguise the assassination by creating a seemingly accidental death. A common method to approach a mission is to incapacitate other characters and wear their outfits as a disguise, which allows the player to gain access to restricted areas more easily. Actions of non-playable characters influence the game. For instance, players can gain more information about the position of their target through listening to a nearby news reporter.

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