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

【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

我們的電影大多是在一如往常的空間拍攝，狹小的環境讓我們要變法或是即慶創作，用一個更具創意的方式，讓觀眾確切跟主角和他們的處境「親近」。我相信在工作現場處理空間上的挑戰，能讓演員、團隊以至最終面對的觀眾，都能構成一份能量。

日以作夜，顧名思義是把日景當夜景拍攝，最佳的時份莫過於黃昏，日落西山下，「天上的光」映照空間帶出優雅的沉鬱感。若用黑白菲林拍攝，加上紅色濾鏡，藍天會變黑。如現代用彩色菲林拍攝，最好不要拍到天空，而要讓影像曝光不足，再為臉龐補光。到數碼攝影時代，有更多方法甚至DaVinci Resolve已能解決不少難題。

很多時，你不能夠為海面打燈，它會看得出被照明。同一道理在沙漠：你怎能携上幾顆大燈去補光，讓它看起來像月亮映照遼闊沙漠的模樣。當你在北歐夏季時間拍攝，當地日照至晚上11點….在冰島，太陽高懸地平線上，24小時晝夜不息….當你要去一個准予你拍攝的地方拍攝，那為何一定要選擇這地方，若非本來就能有其他選擇？

拍攝「真」夜景，每個人的精力大約到凌晨2點便慢慢減退….你減慢了速度，腦袋也不如日間般靈光….喝一杯咖啡或威士忌或有幫助，大約到凌晨4點倦意的循環漸過，但始終失去了專注和行動力。

對我來說，拍攝《三更之回家》的美感在於採取了實務的選擇，大量以日景作夜景拍攝。故事的主角們像處身「地獄的邊緣」：一個抽象又不明確的地方。他們的世界就只有PMQ這空間，它是在世界外圍的邊緣，所以我認為它值得有屬於自己的觸感、外觀和氛圍。我希望大家永遠不知日夜，就像故事帶出我們無從知道何謂真實與幻象，夢想與夢魘。

Most of our films are made in the space in which they are told. The limitations of small spaces make one adapt, or improvise, and respond to what is there in a more creative way I believe the audience feels literally “closer” to the characters and their predicaments because of this. I am sure that in “solving” the challenges of the working environment, a certain energy is created which engages the actors, the team and ultimately an audience.

Day for Night means what it says: you shoot a night scene during the daylight hours. It works best when around dusk when the sun has gone down but what is called “sky light” gives the space an ethereal moodiness. With black and white film, a red filter would turn a blue sky black. With modern colour film, it’s best to keep the sky out of shot and underexpose the image but try to light up the faces. With new digital technology there is a whole lot even DaVinci Resolve can help you achieve.

In most situations you can’t light the sea. It will look lit. Same thing with the desert: how can you get big lamps far enough out there to make it look like the moon has lit such a vast space. When you shoot in Northern Europe in Summer in most places it’s light till 11 pm … in Iceland the sun is hangs on the horizon for the full 24 hours of a day …. So you make the film the location allows you to make. And anyway why did you choose to make it here or there if the way the place is not the reason you came here in the first place?

When you shoot “ real ” night everyone’s energy starts to fade around 2 am …. You slow down. Your mind doesn't react as fast … a coffee or a whiskey might help, and usually most come out of this cycle around 4 am, but still you lose focus and function.

But for me with Three, Going Home is was as much an aesthetic as practical choice to shoot so much day for night. It seemed to me that the characters were in some kind of LIMBO: an abstract, unspecified place . Their world is that PMQ space itself. It is outside the outside world, so I felt it deserved a feel and look and mood of its own. I hoped we would never really know what time of day or night it is, just as the story suggests that we don't know what is real or imagined, fantasy or nightmare.

影片來源Video:《三更之回家》 “Three, Going Home” (2002)

#前荷里活道已婚警察宿舍 #三更之回家 #陳可辛 #真實與幻象
#PMQ #ThreeGoingHome #FruitChan #realorimagined

Some excerpts from U.S Secretary of State Mike Pompeo’s Recent Speech:

“We have to draw common lines in the sand that cannot be washed away by the CCP’s bargains or their blandishments. Indeed, this is what the United States did recently when we rejected China’s unlawful claims in the South China Sea once and for all, as we have urged countries to become Clean Countries so that their citizens’ private information doesn’t end up in the hand of the Chinese Communist Party. We did it by setting standards.”
..

“Now, it’s true, it’s difficult. It’s difficult for some small countries. They fear being picked off. Some of them for that reason simply don’t have the ability, the courage to stand with us for the moment.”

..

“Indeed, we have a NATO ally of ours that hasn’t stood up in the way that it needs to with respect to Hong Kong because they fear Beijing will restrict access to China’s market. This is the kind of timidity that will lead to historic failure, and we can’t repeat it.”

..

“We cannot repeat the mistakes of these past years. The challenge of China demands exertion, energy from democracies – those in Europe, those in Africa, those in South America, and especially those in the Indo-Pacific region.”

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These can be seen as important policy recommendations for "setting standards" and urging "relevant countries to become clean countries." This is especially important for those that want to align with the democratic alliance by showing engagement with clearer norms for policy and standard setting. This is also an important reminder for manufacturers, producers, and R&D centers in the private sector.

If China does not change, it will be encircled. If Taiwan does not join, it will fall out of the team of like minded democracies.

This is also in line with Taiwan’s national interests. Our commercial interests, intellectual property rights, and brain drain will have a greater mechanism to regulate, instead of having to solely face the world’s second largest power, China, led by the CCP, on its own.

Let’s take a look at the most recent important news:

Huawei is banned while TSMC's global revenue grows against the trend (BBC)

ADB estimates Taiwan’s economic growth in 2020, the best four Asian dragons (Central News Agency)

Taiwan's next project is to establish a strong consensus on external threats so that domestic policies can be discussed more. This positive cycle will make the country better.

In other words, I sincerely believe that there is no need to ridicule any political party's past stance on China because the international situation has completely changed after the Hong Kong incident and the COVID19 epidemic. This is an opportunity given to us by history. However, if the opportunity is not grasped, these parties may be abandoned by the current historical moment and overall public opinion.

Once again, such a democratic country will be stronger by establishing a strong consensus on external threats and opening up debates for domestic policies.

This kind of strengthened democracy will bring us closer with like minded countries.

https://www.state.gov/communist-china-and-the-free-worlds-future/

美國國務卿蓬佩奧20多分的演說。

「我們必須劃定不會被中共的討價還價或他們的花言巧語所侵蝕的共同界線...而且我們還敦促有關國家成為潔淨國家（Clean Countries）以使他們的公民的私人信息不會落入中國共產黨的手中。」

.

「我們是通過設定標準來做到的。」

.

「是的，這是難以做到的。這對於一些小國而言是難以做到的。他們害怕遭到逐一封殺。有些國家正是出於這個原因而根本就沒有能力，沒有勇氣在此時此刻同我們站在一起。的確，我們的一個北約盟國在香港問題上沒有以其應有的方式挺身而出，因為他們害怕北京會限制他們進入中國市場。」



「這種怯懦將導致歷史性失敗，而我們不能重蹈覆轍。」



「我們不能再犯過去這些年的錯誤。中國構成的挑戰要求民主國家——歐洲、非洲、南美洲、特別是印度-太平洋（Indo-Pacific）地區的民主國家——付出努力和精力。」


節錄的這幾段，來自國務卿。作為重要的政策宣示，對於「設定標準」，敦促「有關國家成為潔淨國家」，還有民主同盟等，都在在顯示從戰略到戰術的政策設定，規格標準設定，都會有更明確的規範。對於製造商、生產端，研發商，都是重要的提示。

中國不改變，就會遇到圍堵。台灣不加入，就會落隊。

這也符合台灣的國家利益，我們的商業利益，智慧產權，人才流失，將會有更大的機制去調控，而不用孤獨面對世界第二強權，由中共領導的中國。

我們來看看最近的重要新聞：

華為被禁同時 台積電全球營收逆勢成長(BBC)
亞銀估2020台灣經濟成長 亞洲四小龍最佳（中央社）


台灣接下來的工程，就是對外威脅建立堅強共識，但是對內政策，可以更多更多元的討論，這一種正向的循環，會讓這個國家更好。

換言之，我真心認為不需訕笑任何政黨過去對中國立場 ; 因為國際情勢在香港事件、COVID19疫情之後是徹底變化，這是歷史給予我們的契機。但若不能掌握契機，那這些政黨可能就會被時代、主體民意給拋棄。

再強調一次，對外威脅建立堅強共識，對內政策開啟多元競爭，這樣的民主國家，會更強健。

這樣的民主同盟，會更緊密。

照片來源：美國國務院官方照

The Budapest Bike Maffia is among Hungary’s fastest-growing charitable organisations; it was established at Christmas in 2011 by a small group of young cyclists.

Today, its key mission is the distribution of food and fundraising, focussing on helping those who are homeless and families in need. Each year, the BBM team – made up of over 100 volunteers – take to their bikes to distribute over 100,000 meals, in addition to operating 12 innovative charity projects.

These include Sweet Home, which sees volunteers working to create comfortable homes for local families living in council housing; the Seeds of Hope gardening project; and the BBM 50! initiative, which has the goal of increasing empathy and changing negative attitudes towards Budapest’s homeless population.

Culture Trip creates stories that reveal what is unique and special about a place, its people and its culture.

Find out more about the Budapest Bike Maffia here: https://theculturetrip.com/europe/hungary/articles/cycle-the-hungarian-capital-with-the-budapest-bike-maffia/

To get more Culture Trip visit:
https://www.culturetrip.com
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https://www.pinterest.co.uk/theculturetrip

Welcome to another Longplay or Playthrough.

Castlevania: Bloodlines, known in its native Japan as Akumajō Dracula: Vampire Killer (悪魔城ドラキュラ バンパイアキラー Akumajō Dorakyura: Banpaia Kirā, lit. Devil's Castle Dracula: Vampire Killer), originally released simply as Vampire Killer (バンパイアキラー Banpaia Kirā), or known in Europe and Australia as Castlevania: The New Generation; is one of the most overlooked games in the series, as well as one of the most overlooked games in the Sega Genesis/Megadrive library. Despite being part of a long-running and respected series, it is a hidden gem.

Why is it still a hidden gem? I think it is the overarching aesthetic of the game, including art-direction and animation. This game does not look like any other Castlevania-game, for better and for good. Gone are the hearts and now you collect red gems.

The animations are not very smooth. They are choppy, seem like the walk-cycle of the playable characters move only half their bodies, and their heads seem to teleport back and forth instead of smoothly bobbing back and forth. I think the developers were being too ambitious with the animations, and they either ran out of time, or something I can't think of, because the simpler walk-cycle of Richter in Rondo of Blood looks better. In Rondo, Richter's head stays at the same altitude as he walks - only his arms and legs move.

This is not too say that this game is lacking in visual merit. The developers at Konami pulled out a lot of graphical tricks out of their bag that look phenomenal on the Genesis, and all at a silky-smooth framerate. Why have I uploaded so many Genesis-games? It's because action-games ran better on the console.

Like Rocket Knight Adventures, I played this game on my Toshiba 14" CRT TV while capturing upscaled footage. I used HD Retrovision component-video (YPbPr) cables that went to my OSSC, and captured using a Micomsoft XCapture-1.

I really enjoyed this game. I played it on Easy, and edited out my deaths. I did some farming of "Hearts" before bosses if I could, and I got the worst ending; but I can see myself playing this game again in the future. It's one of those games that is good enough to play over and over again for the rest of your life.

Have a great day.

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Subscribe for more awesome videos! ► https://bit.ly/2M1H2Fy

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The song in my intro and outro was done by Hyper Potions, and it is called Time Trials. You can check out the full song here: https://youtu.be/mnfNWe-HHsI.

福井県から、白いカレーとダチョウとライダーズカフェマッハスリー目指して来てくれました、
ありがとうございます、

また遊びに来てくださいね。

Kawasaki 750RS (..floatage.. Arles) and Kawasaki and Z750FOUR (Zet ..floatage.. Fo) are motorcycles of total displacement 746cc that were manufactured and sold from 1973 Kawasaki to 1978.
Outline

The alias is "Z2 Zetts. " ..("Zettots" or "It is often called Arles (From 750RS of the car name)) in Kansai it... Because Z1 of displacement 903cc was put on the market in 1972, and the gain sales results were also good, and the motorcycle of 750cc or more was not able to sell high popularity by the self-imposed restraint of the industry (large-scale automatic operation two wheel reference) in Japan in Europe and America, the domestic version model of 750cc class was necessary for Kawasaki. Both the boa and the stroke were changed after all and it optimized it as 750cc model though it was scheduled to down the engine of Z1 in the boa at first and to put it on the market. Marvelous sales were achieved at first of the Japan sale, and it became a great car that invented a lot of legends.

Optimization of engine boa/stroke
The reduction to 750cc by the down of the boa was not in view though a Square engine of 66×66mm boa/stroke of Z1(903cc) of the base model, and expected by the expansion to about 1000cc by the boa improvement in the future. The change in the stroke cannot help doing the crank shaft as a complete new design, and it is very disadvantageous in the point of time and cost. However, when it is adjusted to about 750cc only the boa down, it becomes about 60mm, and, with this, the boa diameter :.

* The new design of the cylinder head is needed so that exhaust valve may
interfere as it is.
* It becomes a long stroke, and it is unsuitable for the image of "High power
car".

Therefore, the reduction of the boa selected the method of stopping within the range where the cylinder head was able to be used as it is, changing the crank instead, and reducing the stroke.

The displacement was improved to Z1000, and two Z900 for export was made a muffler at the same time in 1976(model in 1977). However, even four Z750FX sales in 1979 kept defending the style of the muffler as for Z750FOUR (The model name changes in 1976) for Japan.

The model cycle is exceptional ..continuing for eight years like the same basic the engine and the frame until the model disappears as Z750FX(Z750 D3) in 1980.. as the motor cycle of comparatively short Japan.

Moreover, after the production of main bodies of the vehicle ends, it is familiar with the rearview mirror designed for Z1 and Z2 long by the name of "Z2 mirror" (Zettsumirar) in the articles market.

It can be difficult to take the large-sized car the production discontinuance this time about the problem of the license system and it be hardly reflected by the secondhand market because it was at the time of the new model rush such as HONDA and CB750Four. However, the one that was 200,000 yen or less till then came for the sudden rise in the influence of the cartoon or the secondhand car market to start in around 1987, and to reach as much as 800,000 yen by this level, too. Still, two wheels magazine at that time is fueled what , saying that "In addition, rise if it doesn't buy it now". Moreover, Z1 was assumed beginning at this time, and a lot of phenomena motorcycles' produced at the motorcycle and the local factory that had been exported to foreign countries visiting Japan came to be seen. It has dealings over the vehicle where the level is good at a high price by an initial type more than the new car of a present this class as of now. Moreover, it is big existence as it becomes the motif of the styling of Zefarshirez as one of the models in which the motorcycle of Kawasaki is symbolized now.

It is still said that it often appears in the drama and the cartoon, and it is set as past image or hot-rodder's own car.

It is additionally equipped from the anxiety of the battery and the charge system to reliability with the kick-starter though the self starter by the starter motor was widespread at the Z2 sale this time.