【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2部Youtube影片,追蹤數超過43萬的網紅Shawn Lee,也在其Youtube影片中提到,SHAWN LEE – MADLIFE CHECK OUT REJUVENATE DANCE CREW'S CHANNEL https://www.youtube.com/user/RejuvenateDanceCrew Available on iTunes https://itun.es/...
product life cycle management 在 Shawn Lee Facebook 的最佳貼文
New track releasing on 18 JULY 2016 #FavSubSL
SHAWN LEE – MADLIFE
Every one should have a #MADLife!
Available on
iTunes
https://itun.es/my/785d_
Amazon
https://www.amazon.com/gp/product/B017Z07FBE/183-9319294-2967815?ie=UTF8&*Version*=1&*entries*=0
Spotify,
https://open.spotify.com/track/2ITUsSySepd7i01yzuFeBu
Follow me on
Instagram
http://instagram.com/shawnleebeatbox
Facebook
http://facebook.com/shawnleefanpage
Twitter
http://twitter.com/shawnleebeatbox
LYRICS :
[Verse1]
Hey, you, staring in doubt
Gotta keep my head, out of the cloud
Vision, high and long like cirrus
Don't get stuck in a cycle now, viscious.
Mad life, do it let go
Chances won't keep knocking on the door
Aventador, (zoom) like woah
Catch me if you can, haters move like slo-mo
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
[Verse2]
Bring the roof down, bring the, bring the roof down
What goes around comes around
Talk of the town
Get loud for me, Come on, grand prix
Loud print luxury, Givenchy
Imma make you queen, empire
If you're feelin nice, I can make you feel better
Twinkle, little diamonds in the sky
Clarity, meticulous, Shawn Lee
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
MadLife, my style, Je Ne Sais Quoi x8
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
Special thanks to :
Giant Ants
Event Plus
Virtigo Studio
Peanut Butter Studio
Rejuvenate Dance crew
Core Studios
Idotshirt
Amplitude Barber Shop
Gary Cheok
Brian See
Riders Garage
Art Of Speed
Sneaker Boo
The Class
Oregi
Rice | Photos
Shawn Lee "MadLife"
Video directed by Core Studios
Words by Shawn Lee & Az 'Avex' Azman
Music by Avex.
Music performed and recorded by Avex.
Vocals recorded by Daniel Veerapen.
Mixed by Ezekiel Keran for 65thPrecinct.
Mastered by Luca Pretolesi at DMI Studio, Las Vegas.
Produced by Avex for Boxavex Entertainment, Melbourne.
Album Visuals by Idotshirt
Photography by Jeremy Choy
Choreography : Danny Lee
Dancers : Rejuvenate Dance Crew
Hair stylist : Lex Low
Make up: Gary Cheok and Shanice Yong
Wardrobe : Brian See
Recording Label : Paranomal Records
Management : Giant Ants Talent Hub
For Bookings
Contact-
Alan Thoo
(+6014.600.000.3)
alan@giant-ants.com
product life cycle management 在 Shawn Lee Youtube 的精選貼文
SHAWN LEE – MADLIFE
CHECK OUT REJUVENATE DANCE CREW'S CHANNEL
https://www.youtube.com/user/RejuvenateDanceCrew
Available on
iTunes
https://itun.es/my/785d_
Amazon
https://www.amazon.com/gp/product/B017Z07FBE/183-9319294-2967815?ie=UTF8&*Version*=1&*entries*=0
Spotify,
https://open.spotify.com/track/2ITUsSySepd7i01yzuFeBu
Follow me on
Instagram
http://instagram.com/shawnleebeatbox
Facebook
http://facebook.com/shawnleefanpage
Twitter
http://twitter.com/shawnleebeatbox
LYRICS :
[Verse1]
Hey, you, staring in doubt
Gotta keep my head, out of the cloud
Vision, high and long like cirrus
Don't get stuck in a cycle now, viscious.
Mad life, do it let go
Chances won't keep knocking on the door
Aventador, (zoom) like woah
Catch me if you can, haters move like slo-mo
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
[Verse2]
Bring the roof down, bring the, bring the roof down
What goes around comes around
Talk of the town
Get loud for me, Come on, grand prix
Loud print luxury, Givenchy
Imma make you queen, empire
If you're feelin nice, I can make you feel better
Twinkle, little diamonds in the sky
Clarity, meticulous, Shawn Lee
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
MadLife, my style, Je Ne Sais Quoi x8
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
Special thanks to :
Giant Ants
Event Plus
Virtigo Studio
Peanut Butter Studio
Rejuvenate Dance crew
Core Studios
Idotshirt
Amplitude Barber Shop
Gary Cheok
Brian See
Riders Garage
Art Of Speed
Sneaker Boo
The Class
Oregi
Rice | Photos
Shawn Lee "MadLife"
Video directed by Core Studios
Words by Shawn Lee & Az 'Avex' Azman
Music by Avex.
Music performed and recorded by Avex.
Vocals recorded by Daniel Veerapen.
Mixed by Ezekiel Keran for 65thPrecinct.
Mastered by Luca Pretolesi at DMI Studio, Las Vegas.
Produced by Avex for Boxavex Entertainment, Melbourne.
Album Visuals by Idotshirt
Photography by Jeremy Choy
Choreography : Danny Lee
Dancers : Rejuvenate Dance Crew
Hair stylist : Lex Low
Make up: Gary Cheok
Wardrobe : Brian See
Recording Label : Paranomal Records
Management : Giant Ants Talent Hub
For Bookings
Contact-
Alan Thoo
(+6014.600.000.3)
alan@giant-ants.com
![post-title](https://i.ytimg.com/vi/1k9U5nncOmo/hqdefault.jpg)
product life cycle management 在 Shawn Lee Youtube 的最佳貼文
SHAWN LEE – MADLIFE
Every one should have a #MADLife!
Available on
iTunes
https://itun.es/my/785d_
Amazon
https://www.amazon.com/gp/product/B017Z07FBE/183-9319294-2967815?ie=UTF8&*Version*=1&*entries*=0
Spotify,
https://open.spotify.com/track/2ITUsSySepd7i01yzuFeBu
Follow me on
Instagram
http://instagram.com/shawnleebeatbox
Facebook
http://facebook.com/shawnleefanpage
Twitter
http://twitter.com/shawnleebeatbox
LYRICS :
[Verse1]
Hey, you, staring in doubt
Gotta keep my head, out of the cloud
Vision, high and long like cirrus
Don't get stuck in a cycle now, viscious.
Mad life, do it let go
Chances won't keep knocking on the door
Aventador, (zoom) like woah
Catch me if you can, haters move like slo-mo
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
[Verse2]
Bring the roof down, bring the, bring the roof down
What goes around comes around
Talk of the town
Get loud for me, Come on, grand prix
Loud print luxury, Givenchy
Imma make you queen, empire
If you're feelin nice, I can make you feel better
Twinkle, little diamonds in the sky
Clarity, meticulous, Shawn Lee
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
MadLife, my style, Je Ne Sais Quoi x8
[Pre-chorus]
Hey he-e-ey move away
On a plane, oh insane
Louboutin red, uh, no restraint
Can you really handle this life in the fast lane?
Special thanks to :
Giant Ants
Event Plus
Virtigo Studio
Peanut Butter Studio
Rejuvenate Dance crew
Core Studios
Idotshirt
Amplitude Barber Shop
Gary Cheok
Brian See
Riders Garage
Art Of Speed
Sneaker Boo
The Class
Oregi
Rice | Photos
Shawn Lee "MadLife"
Video directed by Core Studios
Words by Shawn Lee & Az 'Avex' Azman
Music by Avex.
Music performed and recorded by Avex.
Vocals recorded by Daniel Veerapen.
Mixed by Ezekiel Keran for 65thPrecinct.
Mastered by Luca Pretolesi at DMI Studio, Las Vegas.
Produced by Avex for Boxavex Entertainment, Melbourne.
Album Visuals by Idotshirt
Photography by Jeremy Choy
Choreography : Danny Lee
Dancers : Rejuvenate Dance Crew
Hair stylist : Lex Low
Make up: Gary Cheok and Shanice Yong
Wardrobe : Brian See
Recording Label : Paranomal Records
Management : Giant Ants Talent Hub
For Bookings
Contact-
Alan Thoo
(+6014.600.000.3)
alan@giant-ants.com
![post-title](https://i.ytimg.com/vi/cjh4Smth-qM/hqdefault.jpg)