【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
同時也有6部Youtube影片,追蹤數超過5,140的網紅Ghost Island Media 鬼島之音,也在其Youtube影片中提到,This week, we brought back Emily Cardinali on the show! She was one of our very first producers, and she had really wanted to cover sustainable menstr...
「life cycle of product」的推薦目錄:
- 關於life cycle of product 在 台灣光鹽生物科技學苑 Facebook 的最佳解答
- 關於life cycle of product 在 Guerlain Facebook 的精選貼文
- 關於life cycle of product 在 矽谷阿雅 Anya Cheng Facebook 的最佳貼文
- 關於life cycle of product 在 Ghost Island Media 鬼島之音 Youtube 的最佳貼文
- 關於life cycle of product 在 Sherry Go Sharing Youtube 的最佳解答
- 關於life cycle of product 在 Gapthanavate Youtube 的精選貼文
- 關於life cycle of product 在 Product and Technology Life Cycles 的評價
life cycle of product 在 Guerlain Facebook 的精選貼文
Reduce, reuse, recycle: Abeille Royale is at the forefront of Guerlain's sustainability commitments.
Relaunched in 2019 with lighter packaging, the collection's glass jars are made from 90% recycled glass. The result: a reduction in our carbon footprint by 44%.*
*Analysis on the life cycle of a pot in comparison to the previous product (tool developed with the EVEA) taking into account all three steps in the lifecycle: materials, production, transportation.
life cycle of product 在 矽谷阿雅 Anya Cheng Facebook 的最佳貼文
矽谷電商公司徵才 迎擊Shopify
大量客製化服飾電商公司Scalable Press (Shopify競爭對手)徵產品經理 工程師 設計師 行銷 人資 地點台灣&矽谷
身在矽谷,每天都有很多獵頭來信,大部分是在矽谷的機會,但也有在紐約, 新加坡, 中國, 台灣等地的機會。各式各樣有趣的公司,但不見得都適合阿雅。以前我都直接略過,最近想說花點時間了解職缺,經過獵頭同意後,分享給大家,希望能幫助到比我更適合的你們!(所以我沒有在獵頭,可以請我幫忙看履歷,但不要再請我去career fair囉,哈哈)
Scalable Press是家以印t-shirt起家的矽谷公司,創辦人當學生有天想印t-shirt,發現廠商們都又慢又爛又貴,決定開始設計科技,把印t-shirt這個領域透過科技大幅降低成本,不久就變成了產品的領頭羊,特別是在亞洲中小型賣家賣到美國市場的這塊,成為相當賺錢的新創,市佔率遠大於大名氣的競爭對手Teespring, Design by Human等。
近年,他們擴張到電商領域,幫助中小型企業像Shopify一樣做電商,Shopify專注在美國中大型企業,Scalable Press則著重在東南雅台灣中小型企業,幫企業印製產品,也透過科技幫他們把產品賣到美國。招聘:
Product Designer Taipei
Software Engineer Taipei
Sr. Product Manager Taipei (不在網站上,但有在招)
Lead Product Manager Taipei (不在網站上,但有在招)
Chief Operating Officer San Francisco
Marketing and Support Manager San Francisco
Head of Product San Francisco
Technical Recruiter Taipei
👉職缺說明 https://scalablepress.com/careers#open-positions
👉有興趣可以直接寄英文履歷給公司人資(他不會看中文喔!)[email protected] (https://www.linkedin.com/in/attilioarmeni/)
❗️注意:產品經理product manager跟專案經理project manager不一樣!product manager管what; project manager管when。對,我知道台灣的產品經理都要兼著兩個做,但在美國中大型公司找工作,這是兩個完全不同的職位。說兩個都會又沒有很多年工作經驗,聽起來就是兩個都不太會。
❗️投之前先確定你的https://www.linkedin.com/已經改好,有要投的職位的相關關鍵字如果沒有好的Linkedin,很多獵頭根本不會看你的履歷
✅ 產品經理的履歷關鍵字
👍🏻職稱:Product Director, Product Manager, Product Owner, Product Specialist, Business Analyst
👍🏻工作內容和流程:product vision, product strategy, persona, research, user journey, people problem, problem selection criteria, design thinking, design sprint, concept testing, product life cycle, product roadmap, feature development, solutions for people problem, solution selection criteria, feature prioritization, business case, hypothesis, minimum viable product (MVP), working with cross-functional teams including engineers/ UX and UI designers/analysts, agile, scrum, product development sprint, product requirements, jira, user story, acceptance criteria, goal, metrics, counter metrics, product analytics, a/b testing, growth hacking, go to market, product market fit
✅阿雅履歷範本借你用 https://bit.ly/2HYi9e5
❤️加入臉書「慌世代拓荒時代」,我會貼更多美國工作和免費講座訊息 https://www.facebook.com/groups/165581641033912/
❤️追蹤阿雅IG @AnyaCheng0908
❤️Linkeind上可以加阿雅 www.linkedin.com/in/anyacheng/
❤️履歷需要有人幫你看看 可以粉專私訊傳你的Linkedin連結給阿雅
life cycle of product 在 Ghost Island Media 鬼島之音 Youtube 的最佳貼文
This week, we brought back Emily Cardinali on the show! She was one of our very first producers, and she had really wanted to cover sustainable menstrual products with us. So, after our interview with Isabel Aagard last episode, we reached out to Emily about her own experiences with green tampons.
N8 and Emily discuss the guilt of half of our human population, tips on identifying sustainable products, and the pros and cons of every sort of menstrual product sold on the market.
Support us on Patreon:
http://patreon.com/wastenotwhynot
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ask@wastenotwhynot.com
SHOW CREDIT
Emily Y. Wu (Executive Producer)
https://twitter.com/emilyywu
Nate Maynard (Producer / Host)
https://twitter.com/N8MAY
Yu-Chen Lai (Producer / Editing)
https://twitter.com/aGuavaEmoji
Ghost Island Media (Production Company)
https://twitter.com/ghostislandme
www.ghostisland.media
MB01JWCAEJK3H5L
life cycle of product 在 Sherry Go Sharing Youtube 的最佳解答
Sharing is caring this product suitable for mommies and ladies that love beauty products. To know more of the product can visit www.lunavie.com.
Lunavie Portable UV Sterilizer & Dryer, it is easy for travel use too. If you are bringing baby to holiday, you might want to consider this. The 3 pin plug is easy to use for household in Malaysia.
The Lunavie Portable UV Sterilizer & Dryer is a convenient sterlizing household unit. With the Phillips UV lamp, the Lunavie UV Sterilizer eliminates 99.9% of harmful bacterial and is safe to use on all of your baby’s various feeding gear while the HEPA Filter blocks up to 99.7 % of air borne dust and particles. It designed with touch screen buttons, simple to use and easy to carry everywhere.
• The direct use of 7 mirror stainless steel allows the UV to refract 360 degrees without hidden angle.
• HEPA clean filtration system resist 99.7% from outside hazardous substances.
• Low temperature drying that prolongs the life cycle of your feeding items & etc.
• Disinfection up to 99.9% of germs, bacterial, molds and viruses.
• Storage setting *activates 2 minutes UV Sterilize every 2 hours.
• Portable size gives you convenience to carry everywhere you go and more space on your countertop.
• Easy to operate with touch screen buttons.
4 Intelligent Programs to choose:
a) Auto: Option to dry and sterilise for 41 & 61 minutes.
b) Sterilize: Option to sterilise only for 11, 16 or 21 minutes.
c) Drying: Option to dry only for 41 or 51 minutes.
d) Storage: With AUTO one cycle *automatically actives 2 minutes sterilise every 2 hours for total 72 hours.
Specification
• Product Name: Portable UV Sterilizer & Dryer
• Sterilizing Power: 4W
• Dryer Power: 75W
• Voltage: 220v-240v, 50hz-60Hz
• Inner Capacity: 7L
• Net Weight: 2.02kg
• Gross Weight: 3.1kg
• Product Size: 280*280*247mm
• Warranty: 2 Year Warranty
Warranty card can be find in the box.
life cycle of product 在 Gapthanavate Youtube 的精選貼文
เราพบว่า กระดาษห่อของขวัญมีอายุการใช้งานที่สั้นมาก เพราะทันทีที่มันถึงมือผู้รับ มันจะถูกฉีกทิ้งลงถังขยะทันที คงจะดีไม่น้อยถ้าเราสามารถยืดอายุให้กระดาษห่อของขวัญได้ แต่จะทำอย่างไร ?
ด้วยหลักการง่ายๆ คือ การใช้ซ้ำ หรือ Reuse
เราจึงออกแบบกระดาษห่อของขวัญให้มี “รอยปรุ” ทั่วแผ่น ในลักษณะของตาราง เมื่อผู้รับได้รับกล่องของขวัญก็สามารถคลี่กระดาษห่อออกและเปลี่ยนพฤติกรรมจากการฉีกกระดาษทิ้งให้เป็นฉีกตามรอยปรุ เพื่อนำไป Reuse ให้เกิดประโยชน์ต่อไป ไม่ว่าจะนำไปเป็นกระดาษโน้ตขนาดเล็ก(notepad) นำไปห่อปกสมุด นำไปตัดเป็นเคสมือถือจากกระดาษ นำไปพับออริกามิ หรือนำไปใช้ในงานฝีมือ งาน DIY ต่างๆ เป็นต้น
In every year, billion of trees are being cut down just to make gift wrapping papers. Unfortunately, their life cycle tends to be very short once the receiver got the present. Would not it be great if we can extend the life of gift wrapping papers ? This is the beauty behind this ‘perforated’ wrapping paper idea which aims to reshape consumers' behavior to reuse and extend the life cycle from ordinary wrapping paper to a notepad, notebook cover, origami paper, and various DIY ideas.
Material : Recycled paper 80 gsm.
Printing Process : 4 color printing with Soy based ink / perforated grid
Size : 720 x 480 mm.
*** (this product is covered by patent) ***
All patterns and designs are created and copyrights of A piece(s) of paper, a graphic studio based in Bangkok, Thailand. With passion, love and eco-friendly thinking, we hope our unique design can bring happiness to you.
life cycle of product 在 Product and Technology Life Cycles 的推薦與評價
Life cycles Series of stages though which something passes during its lifetime. are a very useful way to understand how products and technology evolve over ... ... <看更多>