關於 special education online resources ，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

【#SupportHKfootball】My Expat Friends, please support our non-profit crowdfunding project! If you could support us by making donation of small amount, we will have the resources to conduct a study on the state of Hong Kong's football facilities and make use of such objective research findings to press the government for releasing more lands for football development!

▋Sponsor together (#Donate to football study)：
https://goo.gl/UgWaW7
▋Participate together (#Register as voluntary football researchers)：
https://goo.gl/1mS9ve

//Following the successful campaign to preserve the Kitchee centre, Support HK Football now has a bigger ambition – to crowdfund HK$40,000 and recruit volunteers to conduct a study on the state of Hong Kong’s football facilities. Cooperating with the Polytechnic University, Chan said that Support HK Football will survey users at pitches across Hong Kong on every day of the week at different times. Ultimately, Chan wants to convince the government to replicate the Kitchee model across the city. “We want these facilities to be available at different districts and for different clubs.

..... Last year, Education University professor Brian Fong founded the WeMaker non-profit crowdfunding platform, through which Support HK Football will hope to gather resources. Fong believes that the process of speaking to amateur players will empower a community that may not be used to advocacy. “You might have expected there to be a democratic government which is accountable to the people and improve lives,” said Fong. “But if the government fails to do something, you can fix it within civil society – or lead the way in persuading the government to it… it’s a community service.”//

#WeMaker #ProjectCivicAutonomy #Crowdfunding #Crowdsourcing #SponsorTogether #ParticipateTogether #SaveHongKong #WeAreHongKong #HongKongFighting #HongKong

【#SupportHKfootball】Please support us to crowdfund HK$40,000 to conduct a study on the state of Hong Kong's football facilities. With your support, we could make use of objective research findings to press the government for releasing more lands for football development! We are Hong Kong and we need your support!

▋Sponsor together (#Donate to football study)：
https://goo.gl/UgWaW7
▋Participate together (#Register as voluntary football researchers)：
https://goo.gl/1mS9ve

//Following the successful campaign to preserve the Kitchee centre, Support HK Football now has a bigger ambition – to crowdfund HK$40,000 and recruit volunteers to conduct a study on the state of Hong Kong’s football facilities. Cooperating with the Polytechnic University, Chan said that Support HK Football will survey users at pitches across Hong Kong on every day of the week at different times. Ultimately, Chan wants to convince the government to replicate the Kitchee model across the city. “We want these facilities to be available at different districts and for different clubs.

..... Last year, Education University professor Brian Fong founded the WeMaker non-profit crowdfunding platform, through which Support HK Football will hope to gather resources. Fong believes that the process of speaking to amateur players will empower a community that may not be used to advocacy. “You might have expected there to be a democratic government which is accountable to the people and improve lives,” said Fong. “But if the government fails to do something, you can fix it within civil society – or lead the way in persuading the government to it… it’s a community service.”//

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👉👉👉 “Support HK Football” follows up football development in Hong Kong and hopes to conduct a study on the state of football facilities. By surveying users at pitches across different districts, this proposed study aims to convince the government to release more lands for football development.

【Sponsor together】‬‬‬‬‬‬‬‬‬
💵 Crowdfunding target：HK$40,000
📝 Reporting：After the completion of crowdfunding, progress reports will be released via WeMaker’s website every 3 months
💰 Use of fund：
1/ $30,000 will be spent for recruiting a project researcher and paying transport fee of volunteers
2/ $5,000 will be spent for organizing a Football Roundtable
3/ $5,000 will be spent for policy advocacy (street booths, design and printing, etc.)
*All the funds raised shall be solely used for operating this project. If the donation received exceeds the original crowdfunding target, extra funding shall be used for expanding the operation of the project.

【Participate together】‬‬‬‬‬‬‬‬‬
💼 Duties：Surveying users at pitches across different districts
💻 Working time：Each volunteer is expected to participate in two rounds of surveys
💪 Skills：No special requirements, though football fans are better
📝 Briefing：December 3 at 15:00
🎁 Rewards：Transport fee, thank-you letter

//Friendly reminder: WeMaker website only accepts online donation via Paypal and it is a Chinese platform. If you tend not to make online donation or you don't understand Chinese, please make your crossed cheque payable to "WeMaker Limited" and send it to: "Unit C, 4/F, China Insurance Bldg., 48 Cameron Road, Tsim Sha Tsui, Kowloon (Attn: WeMaker Limited)". Remember to write down the project name you would like to sponsor on the back of your cheque.//

#WeMaker #ProjectCivicAutonomy #Crowdfunding #Crowdsourcing #SponsorTogether #ParticipateTogether #SaveHongKong #WeAreHongKong #HongKongFighting #HongKong

[Vietnam]_AmCham đang bước vào giai đoạn tìm ứng viên cho học bổng AmCham Scholar. Đây là chương trình học bổng cho các bạn sinh viên năm cuối trên địa bàn Hà Nội.

2016 AmCham Scholars Program

- Who Can Apply:

AmCham is looking to reward the best-of-the-best, regardless of which university you attend. Final year students that will graduate between September 1, 2016 and September 1, 2017 from all accredited universities in Hanoi are eligible to apply to become a 2016 AmCham Scholar:
Applicant must be a “full-time” student.
Applicant must have a cumulative grade point average (GPA) of 7.0 out of 10.0 (or 3.0 out of 4.0) or above.
Applicant must have an active record of school/social/community service activities.
Applicant must be able to communicate effectively in English-language.

- Why You Should Apply:

Receiving an AmCham Scholarship looks great, whether you intend to apply for a job after graduation, or whether you intend to continue your education in Vietnam or abroad.
AmCham Scholars will be recognized by over 1300 AmCham members throughout Vietnam.
Applications will be reviewed by human resource managers from AmCham member companies in Vietnam. This is a great opportunity to get a head-start on looking for a good job after graduation.
CASH – everyone can use some extra money, no matter whether you are rich or poor.
Scholarship winners receive a free job skills training course taught by American business leaders in Hanoi.
Challenge yourself: Fewer than 10 percent of applicants win. Find out if you are good enough.

- What The Winners Receive:

In mid-December, the US Ambassador and American business leaders will award each AmCham Scholar 7,000,000 VND in cash. Runners-up will each receive 2,000,000 VND in cash.
A free job skills training course taught by American business leaders in Hanoi.
Admission to the AmCham Scholars Alumni Club.
Resume exposure to the HR departments of our member companies.
Priority for possible internship positions.
Invitations to selected AmCham events and activities.

- Schedule / Timeline
August 10 Application Instructions Available Online
September 3 Video Submission Deadline
September 18 Results of 1st Round
September 25 Online Questionnaire Deadline
October 5 School Transcript Submission Deadline
October 9 Results of 2nd Round
October 18 English Language Skills Exam
November 6 Results of 3rd Round
November 17-18 Face-to-Face Interviews in English by Human Resource Professionals
December 17 AmCham Scholars Award Ceremony
(1) English Test Sponsor: Apollo Vietnam
(2) Interview in English conducted by AmCham member company Human Resources Experts; Skills evaluated include: Communication, Career Orientation, Teamwork, Creativity, Rational Decision Making, and Leadership.

- How to Apply:
Here is the first step towards becoming a 2016 AmCham Scholar: Create a one-minute YouTube video that describes who you are and why AmCham should choose you? There are many great students applying. What makes you special, different, or better? We need to see you in the video and it needs to be in English-language. Remember, you only have one-minute. Longer videos will be automatically deleted!

While some video proficiency helps, fancy graphics and high-tech cameras aren’t the key to success. Approach your YouTube video with creativity and authenticity – spend the one-minute any way you wish. We don’t expect you to be a professional video editor and please don’t waste money hiring somebody to help you make the world’s greatest video. We are confident that everybody has a friend or relative with a phone that can produce a simple video to let us learn about you. Lots of people apply so this video is what will separate you from the crowd.

Once finished, upload your video to YouTube (click HERE or HERE to learn how to upload a video on YouTube). Then send an email to: scholarship@amchamhanoi.com with “My AmCham Scholars Video” in the subject line. All we want to see in the email is the URL link to your YouTube video and your full contact information. Do not include other attachments (awards, transcripts, photos, letters of recommendation, etc.) because we will only delete them. Do not include a cover letter or other information about why you want the scholarship. We won’t read it.

We just want to see your one-minute video. We must receive your email no later than 9:00pm (Hanoi time) on September 3. If you send at 9:01pm, we will delete it.

All applicants that submit the email will receive a communication from AmCham on September 18 about the next step in this competition.
Be creative. Have fun. Make your video stand out from all the others.