globalbioanalysisconsortium.org

Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

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Global Bioanalysis Consortium | globalbioanalysisconsortium.org Reviews

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Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

<META> KEYWORDS

1 agenda

2 bibliography

3 conference

4 announcements

5 gbc presentations

6 harmonization teams

7 organization

8 our mission

9 disclaimer

10 coupons

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Global Bioanalysis Consortium | globalbioanalysisconsortium.org Reviews

https://globalbioanalysisconsortium.org

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

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globalbioanalysisconsortium.org

1

Global Bioanalysis Consortium

http://www.globalbioanalysisconsortium.org/Agenda

GBC Webinar on Common Topics and Those Specifically of Chromatotraphic Assays. 08:00 AM British Summer Time. New York 3:00 AM. Rio de Janeiro 4:00 AM. Web access link: https:/ www4.gotomeeting.com/register/351298207. Please register in advance. GBC Webinar on Common Topics and Those Specifically for Ligand Binding Assays. 08:00 AM British Summer Time. New York 3:00 AM. Rio de Janeiro 4:00 AM. Web access link: http:/ engage.vevent.com/rt/roche 20130507. Please register in advance. Rio de Janeiro 11:00 Noon.

2

Global Bioanalysis Consortium

http://www.globalbioanalysisconsortium.org/Bibliography

Publications by the Global Bioanalysis Consortium. Or its founding members. Listing of relevant Regulatory documents. On Bioanalytical Method Validation and related fields. Listing of relevant White Papers and Conference Reports. On Bioanalytical Method Validation and related fields.

3

Global Bioanalysis Consortium

http://www.globalbioanalysisconsortium.org/Announcements

Consolidated feedback by GBC on the draft FDA guidance on Bioanalytical Method Validation. The draft FDA Guidance on Bioanalytical Method Validation (BMV) was released 2 weeks ago ( http:/ www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf. Following up on earlier communications from the GBC last year, the Steering Committee came together this week to agree on our next action items:. More info on what this looks like will follow in the next days or weeks. The Webi...

4

Global Bioanalysis Consortium

http://www.globalbioanalysisconsortium.org/GBCPresentations

On this page the GBC slide decks presented at various international meetings and general information decks are made available. Information and slide decks of the 20 harmonization teams ( A1 - A11. Are presented on the subpages under Harmonization Teams. GBC General and Summary slide decks. May 2013 - Outcomes of the Global Bioanalysis Consortium’s Recommendations: Large Molecule and All Molecules Harmonization teams. Apr 2012 - Adaptation and Impact. Jan 2012 - Summary status slides Harmonization Teams.

5

Global Bioanalysis Consortium

http://www.globalbioanalysisconsortium.org/Conference

GBC Global Conference moved to Washington DC area. See also: Adaptation and Impact. The GBC global conference on the harmonzation of bioanalytical guidelines will be held in the Netherlands in the vicinity of Amsterdam. Dates: 25 - 27 September 2012. Where: Leeuwenhorst Conference Center. Registration fee: 600 euro. Delegate Registration: not available yet. Room Registratrion: not opened yet.

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bioanalysisforum.jp

リンク集 | Japan Bioanalysis Forum

http://bioanalysisforum.jp/links

Http:/ www.mhlw.go.jp/. Http:/ www.pmda.go.jp/. Http:/ www.nihs.go.jp/index-j.html. Http:/ www.nihs.go.jp/drug/DrugDiv-J.html. Http:/ bukai.pharm.or.jp/bukai butsuri/home/menu.asp. Http:/ www.jpma.or.jp/. Http:/ www.jga.gr.jp/. Http:/ www.jacl.jp/. Http:/ www.rinshikyo.com/J/top.html. Http:/ www.fda.gov/. Http:/ www.ema.europa.eu/. Http:/ www.oecd-ilibrary.org/environment/oecd-series-on-principles-of-good-laboratory-practice-and-compliance-monitoring 2077785x. Http:/ www.ich.org/.

ebfnewsletter.blogspot.com

The EBF Post: China Days meeting: Request for input

http://ebfnewsletter.blogspot.com/2014/07/china-days-meeting-request-for-input.html

News and announcements of the European Bioanalysis Forum (EBF). Tuesday, July 29, 2014. China Days meeting: Request for input. Our speakers of the clinical studies session are interested to learn from you which aspects, which questions, you would like them to address in their presentations. It specifically concerns these two talks:. 8226; Early Phase clinical studies (Pei Hu, Peking Union Medical College Hospital). 8226; Late Phase clinical studies (Huafang Li, Shanghai Mental Health Center). We discuss ...

ebfnewsletter.blogspot.com

The EBF Post: January 2014

http://ebfnewsletter.blogspot.com/2014_01_01_archive.html

News and announcements of the European Bioanalysis Forum (EBF). Tuesday, January 28, 2014. Mark your calendars: EBF 7th Open Symposium 19-21 November 2014. Links to this post. Tuesday, January 21, 2014. Focus Workshop: Standardized Lab Manual - Agenda. Links to this post. Focus Workshop: Standardized Lab Manual - Call for Registration. Links to this post. Subscribe to: Posts (Atom). Welcome to the weblog of the. EBF China Days, 11-12 September 2014, Berlin. EBF-YSS, 18 November, Hesperia Tower, Barcelona.

ebfnewsletter.blogspot.com

The EBF Post: July 2014

http://ebfnewsletter.blogspot.com/2014_07_01_archive.html

News and announcements of the European Bioanalysis Forum (EBF). Tuesday, July 29, 2014. China Days meeting: Request for input. Our speakers of the clinical studies session are interested to learn from you which aspects, which questions, you would like them to address in their presentations. It specifically concerns these two talks:. 8226; Early Phase clinical studies (Pei Hu, Peking Union Medical College Hospital). 8226; Late Phase clinical studies (Huafang Li, Shanghai Mental Health Center). Are you a y...

ebfnewsletter.blogspot.com

The EBF Post: August 2014

http://ebfnewsletter.blogspot.com/2014_08_01_archive.html

News and announcements of the European Bioanalysis Forum (EBF). Thursday, August 28, 2014. Last Call to Register for the China Days meeting. EBF Knowledge Exchange Meeting. 11-12 September 2014, Maritim Hotel Berlin, Germany. In a previous post. Below you will find the final agenda for the China Days meeting which will be held at the. Detailed information on the meeting can be found at the conference website: http:/ knex2014.europeanbioanalysisforum.eu. On behalf of the EBF and CBF. Http:/ knex2014.e...

ebfnewsletter.blogspot.com

The EBF Post: Webpage Young Scientists Symposium 2014

http://ebfnewsletter.blogspot.com/2014/08/webpage-young-scientists-symposium-2014.html

News and announcements of the European Bioanalysis Forum (EBF). Tuesday, August 5, 2014. Webpage Young Scientists Symposium 2014. Visit http:/ bcn2014.europeanbioanalysisforum.eu/YSS/. For all the relevant information on the upcoming Young Scientists Sympsoium in Barcelona. Subscribe to: Post Comments (Atom). Welcome to the weblog of the. EBF China Days, 11-12 September 2014, Berlin. EBF-YSS, 18 November, Hesperia Tower, Barcelona. EBF 7th Open Symposium: 19-21 November, Barcelona.

ebfnewsletter.blogspot.com

The EBF Post: Young Investigator Award 2014

http://ebfnewsletter.blogspot.com/2014/08/young-investigator-award-2014.html

News and announcements of the European Bioanalysis Forum (EBF). Friday, August 1, 2014. Young Investigator Award 2014. Voting for the Bioanalysis Young Investigator Award 2014 has officially opened. Visit the Zone to vote. In our simple online poll to help determine the winner of this year’s award. Senior Editors of Bioanalysis have narrowed the field down to the five most exceptional candidates, listed below:. Missouri University of Science and Technology, MO, USA) Cristina Guallar-Hoyas. Webpage Young ...

ebfnewsletter.blogspot.com

The EBF Post: Agenda China Days "Meet the Dragon" EBF meeting

http://ebfnewsletter.blogspot.com/2014/08/agenda-china-days-meet-dragon-ebf.html

News and announcements of the European Bioanalysis Forum (EBF). Friday, August 8, 2014. Agenda China Days "Meet the Dragon" EBF meeting. Day 1 – Thusday 11 September 2014. 09:00 – 11:00 Registration. 11:00 – 11:05 Welcome. 11:05 13:00 Doing business in China. Cultural awareness: things can be confusing, pitfalls, keeping face, etiquette. Yang Liu (Yang Liu Design. East meets West – Yang Liu’s personal experience on cultural differences. 13:00 – 14:00 Lunch. 8211; A European perspective. Operational and C...

ebfnewsletter.blogspot.com

The EBF Post: September 2013

http://ebfnewsletter.blogspot.com/2013_09_01_archive.html

News and announcements of the European Bioanalysis Forum (EBF). Friday, September 27, 2013. Program Update EBF 6th Open Symposium. Science, Technology and Regulations Embracing New Paradigms. Hesperia Tower, Barcelona, Spain. We have revised the agenda of the 6th EBF Open Symposium. To discuss the recently released draft FDA Guidance and prepare for Crystal City-V (Baltimore Hilton, 3-5 Dec 2013). A 3h plenary discussion and feedback session will be held on Friday 22. Your active contribution is welcomed.

ebfnewsletter.blogspot.com

The EBF Post: EBF Lab Manual

http://ebfnewsletter.blogspot.com/2014/08/ebf-lab-manual.html

News and announcements of the European Bioanalysis Forum (EBF). Tuesday, August 12, 2014. EBF has issued a lab manual to help standardize the flow of information and sampling procedures in clinical trials. Download now by following this link. This lab manual is the product of a dedicated EBF team which developed it and discussed it with specialists from clinical operations and central laboratories at the February 2014 Focus Workshop in Brussels. Subscribe to: Post Comments (Atom). We discuss on regulator...

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Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

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Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

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Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

globalbioanalysisconsortium.net

Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

globalbioanalysisconsortium.org

Global Bioanalysis Consortium

Welcome to the website of the Global Bioanalysis Consortium (GBC). Global Bioanalysis Consortium Webinars. Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation. Our Goals and Objectives:. Come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and...

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