關於 clinical research site training ，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

#獨家 世界衛生組織將台灣問題相關聲明稿下架！
　
世界衛生組織(WHO)在台灣時間今(6)日凌晨以 "How the World Health Organization works with all people, everywhere" 為題發了一篇聲明稿，試圖為排除台灣參與 WHO 辯解。不過這篇聲明卻在不到 24 小時內就被 WHO 網站下架，直至晚間6時30分仍呈現「找不到網頁」（This page cannot be found），《沃草》透過世衛網站暫存紀錄，獨家為大家揭露該篇聲明內容。
　
聲明中，WHO仍稱與台灣相關的事務為「中國台灣事務」（ Taiwan, China issues），針對全球的種種批評，WHO 仍稱之為誤解（misunderstandings），並聲稱是有些人將「技術性的維護全球公共健康任務」與「決定 WHO 會員資格的權限」混淆，似乎打算以此來回應國際要求讓台灣加入 WHO 的呼聲。
　
聲明中多處重申 WHO 在 3 月 29 日公布的聲明（https://waa.tw/Qsu21N），認為 WHO 與台灣設有聯絡點、台灣專家曾參與 WHO 會議等，並表示台灣參與世界衛生大會的觀察員資格是在一次次的會員國投票中遭到否決，以及提起讓中華人民共和國取代中華民國聯合國席位的聯合國 2758 決議文，表示世界衛生大會遵循此決議及其中的一中原則。
　
似乎是為回應全球對 WHO 應對流行病能力的質疑，WHO 在聲明中表示「有些人可能認為 WHO 成員組成影響我們維護世界安全的能力，但更重要的是要了解我們的治理方式和實踐方式。」
　　　
暫存檔網址：https://waa.tw/dohkIm
聲明截圖：https://drive.google.com/file/d/1VP-KMgP4wb6Oy8jQkOjoSu-DWGS3Xqkb/view
原新聞稿網址：https://waa.tw/lFKd8M
　
（以下為世界衛生組織聲明原文）
標題：Update: How the World Health Organization works with all people, everywhere
發表時間：5 April 2020 Statement

內文：
In recent months we have seen misunderstandings in social media and the news media about how WHO manages global public health issues. In particular, there are a lot of questions about Taiwan, China issues. Some people are confusing WHO’s technical global public health mandate, with the mandate of countries to determine WHO’s membership. Countries decide this. The WHO Secretariat focuses on keeping the world safe.

WHO works to promote the health of all people, everywhere. Indeed, one of our overarching goals is Universal Health Coverage. #healthforall. We are an organization with a staff of physicians, scientists, researchers and public health experts who are committed to serving all people regardless of nationality, race, ethnicity, religion, gender.

This includes the people of Taiwan. We serve them through regular interactions with their experts and authorities on vital public health issues. This has been the case over many years, including during the COVID-19 pandemic.

It is understandable that some people might think that the composition of WHO’s membership affects our ability to keep the world safe. But it is important to understand both how we are governed and how we operate in practice.

WHO is part of the United Nations, whose membership is the mandate of countries. In 1971, countries of the world participating in the United Nations General Assembly recognized the People’s Republic of China as “the only legitimate representative of China,” in effect, a one-China policy. That is contained in UNGA Resolution 2758. In 1972, the World Health Assembly decided in WHA Resolution 25.1 to follow that.

Every year, members have a chance to discuss important proposals during the World Health Assembly, where rules and policies governing WHO are decided. For example, at different times, some countries have proposed giving Taiwan’s authorities a special status – that of observing the annual World Health Assembly.

There have been 14 times over the last 22 years (1997-2006; and in 2008, 2017, 2018, 2019) when countries discussed whether a delegation from Taiwan could attend the World Health Assembly as an observer. Each time the countries decided against it by consensus – except in 1997 and 2004 when there were votes: (by 128 votes to 19 in 1997; and by 133 votes to 25 in 2004). In 2007, the issue wasn’t observer status, but membership, and countries decided against considering that by a vote of 148 to 17.

There have been occasions when it was clear that there was general support among WHO countries for Taiwan to take an observer seat at the World Health Assembly. Between 2009 and 2016, it did so under the name “Chinese Taipei.”

But having a seat at the WHA, or not having a seat at the WHA, does not affect, in any way, whether an area or population benefits from WHO expertise and guidance. WHO helps all people, everywhere.

WHO and Taiwan’s health experts interact throughout the year on vital public health and scientific issues, according to well-established arrangements.

During the current COVID-19 pandemic, interactions have been stepped up, both through existing channels and new ones as well.

Here are examples of WHO-Taiwan interactions around the coronavirus pandemic:

-- There is an established International Health Regulations (IHR) Point of Contact (POC) for Taiwan. Taiwan’s POC receives IHR (2005) communications, provides IHR information updates from Taiwan directly to WHO Headquarters, and has access to the IHR Event Information Site (EIS) system. The EIS system is a password-protected database and information exchange platform supporting the IHR. It is the well-established platform for all IHR communications, back and forth, between WHO and IHR contacts.

-- Health experts from Taiwan participate in two of the key WHO networks set up in January 2020 to support WHO work in the global COVID-19 response. Three experts from Taiwan are part of the WHO Infection Prevention and Control Network: two are part of the WHO Clinical Network. Every week, they join some 60 to 80 other experts from around the globe through a WHO-hosted teleconference, working to advance our knowledge and guidance in this response.

-- Two public health experts from Taiwan participated in the Global Research and Innovation Forum organized by WHO on 11-12 February 2020. They took part, alongside other world scientists, in considering critical research questions and in finding ways to work together to advance the response.

-- Taiwan’s Field Epidemiology Training Program is a member of the Training Programs in Epidemiology and Public Health Interventions Network (also known as “TEPHINET”). WHO shares Global Outbreak Alert and Response Network alerts and requests for assistance with TEPHINET, and those messages are cascaded to the TEPHINET members.

-- WHO, through its technical lead, has directly briefed health authorities from Taiwan and has offered again.

--Taiwan’s health experts and authorities have open access to developments, guidance and other materials through the WHO’s website (www.who.int) and other digital platforms.

--They can access the www.OpenWHO.org platform, which hosts open online courses for decisionmakers and responders around the world. During the COVID-19 pandemic, OpenWHO usage has reached more than 1 million.

--WHO has a designated contact point with their office in Geneva. Through this channel, general questions are handled and when technical concerns arise, WHO technical responses are coordinated.

--WHO also interacts with Taiwan’s health authorities through the European Centre for Disease Prevention and Control.

Importantly, the COVID-19 caseload in Taiwan is low relative to population. We continue to follow developments closely, and WHO is taking lessons learned from all areas.

Interactions with Taiwan during the response to the pandemic is not exceptional. Here are some examples of regular interactions with Taiwan’s health authorities and WHO, over many years, through well-established arrangements, and across many different global health concerns:

Over the course of 2019, Taiwan’s experts were invited to attend 9 WHO technical meetings. They attended 8 of these meetings, contributing to WHO expert processes on issues including immunization, drug-resistant TB, assistive technologies, vaccine safety and SDG targets on NCDs and Mental Health. Prior to the Covid-19 emergency, work was underway for more expert participation from Taiwan in 2020.

On influenza, Taiwan vaccine manufacturer Adimmune contributes to the WHO Pandemic Influenza Preparedness Framework (PIP Framework) and preparations are underway for concluding an agreement between WHO and Adimmune under the PIP Framework for pandemic influenza vaccine products;
In the fight against cancer, experts from Taiwan have contributed to key publications issued by the WHO International Agency for Research on Cancer;
In support of the International Health Regulations, an expert from Taiwan has been appointed to the IHR Expert Roster; and
On a range of other issues, from WHO pre-qualification practices for pharmaceutical manufacturers to malaria, there are exchanges with WHO on practical and technical issues.

It is fair to say that the contribution of Taiwan’s health experts to WHO, and their interactions with us, are well-developed and broad-based. And these interactions add value to the work of WHO and to global health.