【國際認證:英國等國採納免疫橋接核准新疫苗】
一、英國主管單位宣布採納免疫橋接作為批准 COVID-19 疫苗的檢測標準
英國政府,採納類似「台灣模式」核准新疫苗。國際藥物法規主管機構聯盟(ICMRA)於六月召開研討會,針對免疫橋接與保護關聯性達成多點共識,稍早跨國醫藥聯盟Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium(英國、澳洲、新加坡、加拿大、瑞士主管機關組成的聯盟)表示同意採用與現行疫苗比對中和抗體校價的「免疫橋接」,接著英國藥物及保健產品管理局(Medicines and Healthcare Products Regulatory Agency,簡稱 MHRA)接著宣布,可接受設計合理的免疫橋接作為批准 COVID-19 疫苗的檢測標準。
二、英國、澳洲、新加坡、加拿大、瑞士監管機構接納免疫橋接:
聯盟五國成員,同意論證充分設計良好的免疫橋接試驗,是武漢肺炎疫苗取得授權的可行途徑。
Access聯盟引述ICMRA會議有關免疫橋接的共識如下:
‧難以進行傳統安慰劑對照試驗,取得有效性實驗終點的狀況下,可使用免疫橋接。
‧實驗設計:若和高度有效的疫苗比較,應採不劣性(non-inferiority )設計;若和僅達一般標準的疫苗相比,應採優越性(superiority)設計。
‧中和抗體校價可作為預測疫苗有效性的免疫標記。
‧中和抗體校價試驗應使用WHO認證之標準方式。
‧須考慮:1.考慮疫苗平台來選擇合適的疫苗比較品;2.統計標準;3.校正不同組別間的族群特性差異。
‧各國監管機構分享資訊,有助「國際認證」的聚焦。
Access聯盟權衡已核准疫苗的研究實證後,認為中和抗體校價足以作為跨平台免疫橋接試驗的主要終點。
另外,申請者須提供各項資料,包含:
非臨床資料:
‧可證明抵抗變種病毒有效性的動物攻毒實驗
‧(動物實驗之)免疫生成性,包含抗體免疫與細胞免疫
臨床資料:
‧中和抗體校價比較資料
‧免疫生成性資料,包含細胞免疫
‧在體外試驗中,中和變種病毒的能力
‧至少3000名受試者的安全性資料
‧承諾至少追蹤受試者12個月的安全性與免疫生成性,並紀錄臨床有效性數據。
‧承諾進行授權使用後的真實世界有效性研究,研究方案需考慮現行WHO規範。
三、疫情病毒不斷變種,需要更經濟有效的疫苗實驗標準
當然傳統實驗設計方式,仍是最堅實的標準,但在時間和現實環境的雙重壓力問題,確保其有效性的前提下,讓疫苗研發的成本再降低,經過國際相關醫學公衛單位的嚴格討論,免疫橋接已被納入標準。這不是為了哪個特定品牌,而是面對病毒進程,國際公衛對於疫苗研發所做出的世界趨勢決定。
很多人拿免疫橋接來做攻擊,說不是國際標準,說國際上沒有人這麼做,說台灣這樣獨步全球不可思議,但其實免疫橋接在國際間一直都在討論。現在免疫橋接是國際認證的設計了,別的國家都跟在台灣後面做了,希望免疫橋接的紛爭到此為止。
我並不悲觀,相信民眾心裡都有一把尺,很清楚這些事情背後的出發點。台灣的未來比這些口水戰重要得太多,一起繼續努力。
其他相關原文細節,會把報導原文放在留言裡。
同時也有6部Youtube影片,追蹤數超過361萬的網紅Dan Lok,也在其Youtube影片中提到,Looking To Make More Revenue Online? Get Counselled By Marketers Who've Successfully Made 7 Figures Online. Start Today With The Digital Agency Launch...
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canada agency 在 Newtalk新聞 Facebook 的精選貼文
接種AZ疫苗罕見血栓副作用 加拿大通報第2例
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canada agency 在 黃心健 Hsin-Chien Huang Facebook 的最佳貼文
🎉🎉🎉“Samsara Ep1.” Puts Taiwan On the Map! New Media Artist Hsin-Chien Huang Wins the Top Awards of SXSW🏆🏆🏆🥳
The awards ceremony of the American international film festival, South by Southwest Film Festival (SXSW), will be held in the morning on March 20, 2021. The latest VR production created by artist Hsin-Chien Huang has taken the festival by storm and bring home the prestigious “Jury Awards” in the virtual cinema competition category. “Samsara Ep. 1” is the first VR production from Taiwan to receive such honor and has put the creativity of Taiwan on the map!
In the acceptance speech, Huang mentioned that he would like to thank the jury of SXSW for the recognition and encouragement. It was absolutely his honor to win this award. He’d also like to thank the full support from the Ministry of Culture of Taiwan 文化部, the Taiwan Creative Content Agency 文化內容策進院 Taiwan Creative Content Agency , and Kaohsiung Film Archive 高雄市電影館 VR 體感劇院 VR FILM LAB to make it possible to complete the work. Finally, he thanked all the crew members of the production for letting the world see how amazing the VR production from Taiwan.
The story background of “Samsara” is set as a timeline when humans completely destroyed the environment on earth and begin to go on a quest through space for hundreds of years. People try to immigrant to a new planet, so they redesign the DNA to adapt to a new environment and evolve into a new life form. However, after so many years, people gradually realize that it is never possible to find a new planet to settle. They merely keep returning to the original earth they have damaged in a different era, in a different life form, as an endless circle of reincarnation.
The plot involves many different social issues, including ecology, technology, natural resource, and war, and calls on viewers to reflect themselves with a profound philosophical perspective. Moreover, several concepts of embodied cognition are used in the story to make viewers transform into different animals, including Taiwan’s indigenous species, such as Taiwan Blue Magpie and Formosan Black Bear, to interact with the scenes. “Samsara Ep.1” also features the latest somatosensory technology, including the 4Dviews shooting techniques by the Industrial Technology Research Institute and Taiwan Creative Content Agency, with 48 4DV-EX-Z cameras and a digital shooting system composed of a high-sensitivity 4 million-pixel full-color CCD sensor. “Samsara Ep.1” is able to be taken from an omnidirectional view without blind spots and be shot without any blind spots to create the ultimate immersive experience.
The first SXSW was held in Austin, Texas in 1987. This long-standing international event is held around March every year ever since. The festival features various themes, such as films, music, VR/AR, art and games, etc. The SXSW is the world’s largest event for creative content. Many creators and brand owners in the fields will not miss out on the festival. Therefore, the festival has become a trial balloon, attracting hundreds of bands and film crews to participate, estimated over 400,000 people joining the event. This year, the festival has changed the event to an online form for the first time since the pandemic is raging as before. All screening events, industry matchmaking, seminars will be carried out via its own online platform, SXSW Online, without difficulty. It has made it possible for all the artists, creators, and professionals to break down the physical borders and participate in this magnificent annual event together.
There are nine productions in total nominated in the Virtual Cinema Competition category this year, with teams from the US, Canada, the UK, France, Germany, Poland, Australia, South Korea, and so on. This is the first time that “Samsara Ep.1” has competed in the international film festival and has achieved a great result with much international recognition. This is also the first time for Taiwanese production to receive an award from the SXSW competition. The full version of “Samsara” is expected to start the global tour in the second half of the year. Huang said that “Samsara” would return to Taiwan for its Asian premiere and ask the fans in Taiwan to stay tuned!
✔️SXSW website: https://www.sxsw.com/festivals/film-awards/
✔️SXSW YouTube: https://www.youtube.com/watch?v=T9G_7NZh_Oo&feature=emb_logo
#黃心健 #HsinChienHuang #輪迴 #Samsara #Virtualcinemacompetition
#Juryaward
#VR #台灣VR #TaiwanVR
#SXSWFilm #SXSW #2021SXSW #SXSWOnline
canada agency 在 Dan Lok Youtube 的最讚貼文
Looking To Make More Revenue Online? Get Counselled By Marketers Who've Successfully Made 7 Figures Online. Start Today With The Digital Agency Launchpad: https://morerevenueonline.danlok.link
There are countless strategies to make more money online. But not all of them are tried and tested by experts. In this video, Jeremy explains the 3 strategies his agency used to get 42 people to 6-figures a month and 7 people to 7-figure months. Share this video with a fellow online entrepreneur.
▬▬▬▬▬▬▬▬▬▬ Video Highlights ▬▬▬▬▬▬▬▬▬▬
0:00 - Intro: 3 Strategies To Make More Revenue Online
1:01 - Jeremy Haynes: How He Made Money Online
2:16 - Strategy 1 - Horizontal Funnel Scaling
4:01 - Strategy 2 - Successful Action Audit
5:06 - Strategy 3 - Audit The Entire System
7:38 - Digital Agency LaunchPad
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Check out these Top Trending Playlists -
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3.) Dan Lok’s Best Secrets - https://www.youtube.com/watch?v=FZNmFJUuTRs&list=PLEmTTOfet46N3NIYsBQ9wku8UBNhtT9QQ
Dan Lok has been viewed more than 1.7+ billion times across social media for his expertise on how to achieve financial confidence. And is the author of over a dozen international bestselling books.
Dan has also been featured on FOX Business News, MSNBC, CBC, FORBES, Inc, Entrepreneur, and Business Insider.
In addition to his social media presence, Dan Lok is the founder of the Dan Lok Organization, which includes more than two dozen companies - and is a venture capitalist currently evaluating acquisitions in markets such as education, new media, and software.
Some of his companies include Closers.com, Copywriters.com, High Ticket Closers, High Income Copywriters and a dozen of other brands.
And as chairman of DRAGON 100, the world’s most exclusive advisory board, Dan Lok also seeks to provide capital to minority founders and budding entrepreneurs.
Dan Lok trains as hard in the Dojo as he negotiates in the boardroom. And thus has earned himself the name; The Asian Dragon.
If you want the no b.s. way to master your financial destiny, then learn from Dan. Subscribe to his channel now.
★☆★ CONNECT WITH DAN ON SOCIAL MEDIA ★☆★
YouTube: http://youtube.danlok.link
Dan Lok Blog: http://blog.danlok.link
Dan Lok Shop: https://shop.danlok.link
Facebook: http://facebook.danlok.link
Instagram: http://instagram.danlok.link
Linkedin: http://mylinkedin.danlok.link
Podcast: http://thedanlokshow.danlok.link
#DanLok #MakeMoneyOnline #DigitalMarketing
Please understand that by watching Dan’s videos or enrolling in his programs does not mean you’ll get results close to what he’s been able to do (or do anything for that matter).
He’s been in business for over 20 years and his results are not typical.
Most people who watch his videos or enroll in his programs get the “how to” but never take action with the information. Dan is only sharing what has worked for him and his students.
Your results are dependent on many factors… including but not limited to your ability to work hard, commit yourself, and do whatever it takes.
Entering any business is going to involve a level of risk as well as massive commitment and action. If you're not willing to accept that, please DO NOT WATCH DAN’S VIDEOS OR SIGN UP FOR ONE OF HIS PROGRAMS.
This video is about 3 Strategies To Make More Revenue Online.
https://youtu.be/PQz9JoNYX4Q
https://youtu.be/PQz9JoNYX4Q
![post-title](https://i.ytimg.com/vi/PQz9JoNYX4Q/hqdefault.jpg)
canada agency 在 Dan Lok Youtube 的精選貼文
So, You Want To Know How To Earn Money Online? There Are A Bunch Of Different Ways. To Make Sure That You Pick The Most Profitable Way, Check Out The Digital Agency Launchpad. Get Started Making Money Online Without Working Yourself Into A Burnout: https://earningmoneyonline.danlok.link
There are hundreds of ways to earn money online. Become a virtual assistant, work as a freelancer, be an affiliate marketer or start a marketing agency, to name just a few. You see, it’s not only a question of making money online - you want to be able to make enough money without selling too much of your time. If this video was insightful, share it with a friend who wants to get started making money online.
▬▬▬▬▬▬▬▬▬▬ Video Highlights ▬▬▬▬▬▬▬▬▬▬
0:00 - Intro: How To Earn Money Online?
1:01 - Virtual Assistant
1:41 - Freelancing
2:53 - Drop Shipping
3:25 - Brand Specialist
4:01 - Marketing Agency
5:42 - Digital Agency Launchpad
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? SUBSCRIBE TO DAN'S YOUTUBE CHANNEL NOW ?
https://www.youtube.com/danlok?sub_confirmation=1
? Join my YouTube Membership to get access to EXCLUSIVE perks ?
https://www.youtube.com/channel/UCs_6DXZROU29pLvgQdCx4Ww/join
Check out these Top Trending Playlists -
1.) Boss In The Bentley - https://www.youtube.com/playlist?list=PLEmTTOfet46OWsrbWGPnPW8mvDtjge_6-
2.) Sales Tips That Get People To Buy - https://www.youtube.com/watch?v=E6Csz_hvXzw&list=PLEmTTOfet46PvAsPpWByNgUWZ5dLJd_I4
3.) Dan Lok’s Best Secrets - https://www.youtube.com/watch?v=FZNmFJUuTRs&list=PLEmTTOfet46N3NIYsBQ9wku8UBNhtT9QQ
Dan Lok has been viewed more than 1.7+ billion times across social media for his expertise on how to achieve financial confidence. And is the author of over a dozen international bestselling books.
Dan has also been featured on FOX Business News, MSNBC, CBC, FORBES, Inc, Entrepreneur, and Business Insider.
In addition to his social media presence, Dan Lok is the founder of the Dan Lok Organization, which includes more than two dozen companies - and is a venture capitalist currently evaluating acquisitions in markets such as education, new media, and software.
Some of his companies include Closers.com, Copywriters.com, High Ticket Closers, High Income Copywriters and a dozen of other brands.
And as chairman of DRAGON 100, the world’s most exclusive advisory board, Dan Lok also seeks to provide capital to minority founders and budding entrepreneurs.
Dan Lok trains as hard in the Dojo as he negotiates in the boardroom. And thus has earned himself the name; The Asian Dragon.
If you want the no b.s. way to master your financial destiny, then learn from Dan. Subscribe to his channel now.
★☆★ CONNECT WITH DAN ON SOCIAL MEDIA ★☆★
YouTube: http://youtube.danlok.link
Dan Lok Blog: http://blog.danlok.link
Dan Lok Shop: https://shop.danlok.link
Facebook: http://facebook.danlok.link
Instagram: http://instagram.danlok.link
Linkedin: http://mylinkedin.danlok.link
Podcast: http://thedanlokshow.danlok.link
#DanLok #MakeMoneyOnline #WorkFromHome
Please understand that by watching Dan’s videos or enrolling in his programs does not mean you’ll get results close to what he’s been able to do (or do anything for that matter).
He’s been in business for over 20 years and his results are not typical.
Most people who watch his videos or enroll in his programs get the “how to” but never take action with the information. Dan is only sharing what has worked for him and his students.
Your results are dependent on many factors… including but not limited to your ability to work hard, commit yourself, and do whatever it takes.
Entering any business is going to involve a level of risk as well as massive commitment and action. If you're not willing to accept that, please DO NOT WATCH DAN’S VIDEOS OR SIGN UP FOR ONE OF HIS PROGRAMS.
This video is about How To Earn Money Online?
https://youtu.be/_PbLeMIBv4E
https://youtu.be/_PbLeMIBv4E
![post-title](https://i.ytimg.com/vi/_PbLeMIBv4E/hqdefault.jpg)
canada agency 在 Dan Lok Youtube 的最讚貼文
Let’s Get Real - How Can You Make Your First $10,000? For The Full Scope On How To Sell High-Ticket As A Digital Marketer, Join The Next Freedom Challenge With Dan Lok And Jeremy Haynes. Claim Your Seat Today: https://first10000.danlok.link
To make your first $10,000, you need two things: the right mindset and the right services to offer. Watch this video all the way to the end so you can follow Jeremy’s advice step by step. Got something out of this video? Share it with a friend.
▬▬▬▬▬▬▬▬▬▬ Video Highlights ▬▬▬▬▬▬▬▬▬▬
0:00 - Intro: How To Make Your First $10,000
0:57 - How Jeremy Haynes Made His First $10,000
1:30 - The First Step To Making $10,000
04:03 - Recurring Revenue
04:34 - When You Don't Have Skills Yet
06:00 - How To Get First Clients
09:19 - Steps For Success
▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬
? SUBSCRIBE TO DAN'S YOUTUBE CHANNEL NOW ?
https://www.youtube.com/danlok?sub_confirmation=1
? Join my YouTube Membership to get access to EXCLUSIVE perks ?
https://www.youtube.com/channel/UCs_6DXZROU29pLvgQdCx4Ww/join
Check out these Top Trending Playlists -
1.) Boss In The Bentley - https://www.youtube.com/playlist?list=PLEmTTOfet46OWsrbWGPnPW8mvDtjge_6-
2.) Sales Tips That Get People To Buy - https://www.youtube.com/watch?v=E6Csz_hvXzw&list=PLEmTTOfet46PvAsPpWByNgUWZ5dLJd_I4
3.) Dan Lok’s Best Secrets - https://www.youtube.com/watch?v=FZNmFJUuTRs&list=PLEmTTOfet46N3NIYsBQ9wku8UBNhtT9QQ
Dan Lok has been viewed more than 1.7+ billion times across social media for his expertise on how to achieve financial confidence. And is the author of over a dozen international bestselling books.
Dan has also been featured on FOX Business News, MSNBC, CBC, FORBES, Inc, Entrepreneur, and Business Insider.
In addition to his social media presence, Dan Lok is the founder of the Dan Lok Organization, which includes more than two dozen companies - and is a venture capitalist currently evaluating acquisitions in markets such as education, new media, and software.
Some of his companies include Closers.com, Copywriters.com, High Ticket Closers, High Income Copywriters and a dozen of other brands.
And as chairman of DRAGON 100, the world’s most exclusive advisory board, Dan Lok also seeks to provide capital to minority founders and budding entrepreneurs.
Dan Lok trains as hard in the Dojo as he negotiates in the boardroom. And thus has earned himself the name; The Asian Dragon.
If you want the no b.s. way to master your financial destiny, then learn from Dan. Subscribe to his channel now.
★☆★ CONNECT WITH DAN ON SOCIAL MEDIA ★☆★
YouTube: http://youtube.danlok.link
Dan Lok Blog: http://blog.danlok.link
Dan Lok Shop: https://shop.danlok.link
Facebook: http://facebook.danlok.link
Instagram: http://instagram.danlok.link
Linkedin: http://mylinkedin.danlok.link
Podcast: http://thedanlokshow.danlok.link
#DanLok #MakeYourFirst10k #DigitalMarketing
Please understand that by watching Dan’s videos or enrolling in his programs does not mean you’ll get results close to what he’s been able to do (or do anything for that matter).
He’s been in business for over 20 years and his results are not typical.
Most people who watch his videos or enroll in his programs get the “how to” but never take action with the information. Dan is only sharing what has worked for him and his students.
Your results are dependent on many factors… including but not limited to your ability to work hard, commit yourself, and do whatever it takes.
Entering any business is going to involve a level of risk as well as massive commitment and action. If you're not willing to accept that, please DO NOT WATCH DAN’S VIDEOS OR SIGN UP FOR ONE OF HIS PROGRAMS.
This video is about How To Make Your First $10,000.
https://youtu.be/dcWqWwrVtiU
https://youtu.be/dcWqWwrVtiU
![post-title](https://i.ytimg.com/vi/dcWqWwrVtiU/hqdefault.jpg)
canada agency 在 Canada Revenue Agency | Facebook 的推薦與評價
Canada Revenue Agency. 87415 likes · 529 talking about this · 258 were here. Welcome to the Canada Revenue Agency's (CRA) official Facebook page!... ... <看更多>