Good News 🕊 Now you can listen to lectures on international clinical trial with the click of a button! Taught by EU pharma expert anywhere and any place of your choice 🎈
🌎【International Live Webinar】Clinical Trial Management Series🌍
Date and time: 💻 Every Tues & Thurs 20:30 ~ 22:00 from 2/23 to 3/18
Instructor:Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
★ Each online webinar (3 hrs) has 2 sessions, 1.5 hrs each ★
【Course Outline】
📌Part I -Management for Study Drug Supply in Multinational Trials
📌Part II -Conducting Clinical Trials and Writing Relevant SOPs
📌Part III -Clinical Trial Risk Management
📌Part IV -Audits and Inspections of Clinical Trials in Europe
【Target Audience】
(1.) Anyone who is interested in global clinical trials
(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)
【Online Course Fees】
★Price per course: $200 USD
★Price for Clinical Trial Series Bundle:
Clinical Trial Series Bundle (Part I - Part IV) — $700 USD, (original price $800 USD)
🥳 Registration Link:
https://forms.gle/E24XvW8Y34ReTP1w9
(*1) Certificate of Attendance will be issued only if participants complete both sessions of each webinar for which they have signed up
(*2) Certificate of Completed Assessment will be issued only if participants pass the assessment
Organizer:ARC-TRAICOA Co-Organizer:Salt and Light Institute
同時也有1部Youtube影片,追蹤數超過3萬的網紅[email protected],也在其Youtube影片中提到,兒童及青少年濕疹 - 陳欣永兒科專科醫生@FindDoc.com FindDoc Facebook : https://www.facebook.com/FindDoc FindDoc WeChat : 快徳健康香港 FindDoc FindDoc Instagram:@finddochk ...
clinical trial course 在 台灣光鹽生物科技學苑 Facebook 的最佳貼文
【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
clinical trial course 在 良醫生 Dr Ares Facebook 的最佳解答
留心,這報導中的布口罩,不是香港最近的銅芯口罩,或者其他有殺菌能力的口罩。
clinical trial course 在 [email protected] Youtube 的最佳貼文
兒童及青少年濕疹 - 陳欣永兒科專科醫生@FindDoc.com
FindDoc Facebook : https://www.facebook.com/FindDoc
FindDoc WeChat : 快徳健康香港 FindDoc
FindDoc Instagram:@finddochk
(一)濕疹如何影響兒童及青少年? 00:08
(二)有什麼治療方法? 01:03
(三)家長如何幫助兒童及青少年面對濕疹? 03:03
(本短片作健康教育之用,並不可取代任何醫療診斷或治療。治療成效因人而異,如有疑問,請向專業醫療人士諮詢。)
參考資料:
1. Brenninkmeijer, E. E., Legierse, C. M., Sillevis Smitt, J. H., Last, B. F., Grootenhuis, M. A., & Bos, J. D. (2009). The course of life of patients with childhood atopic dermatitis. Pediatric dermatology, 26(1), 14–22. https://doi.org/10.1111/j.1525-1470.2008.00745.x
2. Oh, S. H., Bae, B. G., Park, C. O., Noh, J. Y., Park, I. H., Wu, W. H., & Lee, K. H. (2010). Association of stress with symptoms of atopic dermatitis. Acta dermato-venereologica, 90(6), 582–588. https://doi.org/10.2340/00015555-0933
3. Ricci, G., Bellini, F., Dondi, A., Patrizi, A., & Pession, A. (2011). Atopic dermatitis in adolescence. Dermatology Reports, 4(1), 1. doi:10.4081/dr.2012.e1
4. Camfferman D, Kennedy JD, Gold M, Martin AJ, Lushington K. Eczema and sleep and its relationship to daytime functioning in children. Sleep Med Rev. 2010 Dec;14(6):359-69. doi: 10.1016/j.smrv.2010.01.004. Epub 2010 Apr 14. PMID: 20392655.
5. 濕疹的治療方案. (n.d.). Retrieved March 24, 2021, from https://www.hkasthma.org.hk/hk/about-allergies/%E6%B2%BB%E7%99%82%E6%96%B9%E6%A1%88-2
6. Fabbrocini G, Napolitano M, Megna M, Balato N, Patruno C. Treatment of Atopic Dermatitis with Biologic Drugs. Dermatol Ther (Heidelb). 2018 Dec;8(4):527-538. doi: 10.1007/s13555-018-0258-x. Epub 2018 Sep 4. PMID: 30182182; PMCID: PMC6261117.
7. Senner, S., Seegräber, M., Frey, S., Kendziora, B., Eicher, L., & Wollenberg, A. (2020). Dupilumab for the treatment of adolescents with atopic dermatitis. Expert review of clinical immunology, 16(7), 641–650. https://doi.org/10.1080/1744666X.2020.1801420
8. Simpson, E. L., Paller, A. S., Siegfried, E. C., Boguniewicz, M., Sher, L., Gooderham, M. J., Beck, L. A., Guttman-Yassky, E., Pariser, D., Blauvelt, A., Weisman, J., Lockshin, B., Hultsch, T., Zhang, Q., Kamal, M. A., Davis, J. D., Akinlade, B., Staudinger, H., Hamilton, J. D., Graham, N., … Bansal, A. (2020). Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA dermatology, 156(1), 44–56. https://doi.org/10.1001/jamadermatol.2019.3336
9. The struggle is real: A parent's guide to caring for kids with eczema. (2020, October 23). Retrieved March 29, 2021, from https://nationaleczema.org/parenting-eczema-kids/
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