Agenda

Speaker: Stuart McDougall

Date: 08-May-2013

Time:
08:00 AM British Summer Time
9:00 AM CET/GMT/UCT
New York 3:00 AM
Rio de Janeiro 4:00 AM
Mumbai 12:30
Shanghai 15:00
Tokyo 16:00

Web access link: https://www4.gotomeeting.com/register/351298207

Please register in advance

Speaker: Sherri Dudal

Date: 07-May-2013

Time:
08:00 AM British Summer Time
9:00 AM CET/GMT/UCT
New York 3:00 AM
Rio de Janeiro 4:00 AM
Mumbai 12:30
Shanghai 15:00
Tokyo 16:00

Web access link: http://engage.vevent.com/rt/roche~20130507

Please register in advance.

Speaker: Binodh DeSilva

Date: 06-May-2013

Time:
10:00 AM EDT (14:00 pm GMT/UCT)
Rio de Janeiro 11:00 Noon
London 15:00
Brussels 16:00 Mumbai 19:30
Shanghai 22:00 Tokyo 23:00

Live Meeting Access Link: meet:sip:Binodh.Desilva@bms.com;gruu;opaque=app:conf:focus:id:1b244c25a4154924a2e97267c491fcd8%3Fconf-key=hrAWqb8v32 (paste link to meeting into Live Meeting software)
Install Live Meeting: http://r.office.microsoft.com/r/rlidOCSR2?clid=1033&p1=livemeeting

Teleconference information for Domestic & Int'l: http://www.intercall.com/bms
Conf Code: 9469554

Speaker: Eric Fluhler

Date: 03-May-2013

Time:
11:00 AM EDT (15:00 GMT/UCT)
Rio de Janeiro 12:00 Noon
London 16:00
Brussels 17:00
Mumbai 20:30
Shanghai 23:00
Tokyo Midnight (3-May to 4-May)

Web access link: https://pfizerevents.webex.com/pfizerevents/onstage/g.php?d=493178300&t=a
Password: GBCwebinar

Based upon the announcement that the FDA will release their draft update guidance on bioanalytical method validation this summer and subsequently that an AAPS-FDA Crystal City V conference is planned to be held within 90 days after release of the guidance document, the GBC SC has decided to move the GBC global conference from the Netherlands to the Washington DC area. A date can not be set yet, but the conference is planned to be held 2 days prior to the AAPS-FDA meeting.

See also: Adaptation and Impact

The conference program will include topics as:

• Tiered approach in practice - are our minds ready for it?
• Bioanalysis and Toxicokinetics, or how to marry GLP and science
• "Oral Posters session"
• A progress update since Large meets Small
• Technology updates # Micro sampling - updates on DBS & recent developments
• Large molecule/LBA dedicated sessions
• Electronic raw data and Electronic Lab Notebook (ELN)
• Is quantitative bioanalysis ready for HR/MS
• Young Scientist Award
• BA clinics - consult the doctor (Breakout)
• Global Harmonization: has the dust settled? & "updates from the globe"
• Challenges in global clinical studies

The Local Organizing Committee and the Mass Spectrometry Society of Japan (MSSJ) welcome you all to attend the 19th IMSC. It is a particular honor that this landmark event - the first IMSC to be held outside Europe - will be staged in Asia.

The symposium will include topics as:

・ Opening remarks
・ JBF activity report
・ Invited lecture by Global Bioanalysis Consortium (GBC)-Steering Committee members: 
    Michaela Golob (Merck-Serono), Daniel Tang (Icon, APAC), Fabio Garofolo (Algorithme Pharma)
・ GBC Harmonization Team progress report
・ Poster presentation by Japanese GBC Harmonization Team members
・ Panel discussion on current situation regarding regulated bioanalysis

The purpose of this four-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, their metabolites and endogenous biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program will be a mixture of lecture, discussion groups and workshops

With scientific developments and regulatory expectations not always in concert, our 3rd Focus meeting aims to connect on the potential of a broad array of new technologies. We will provide a scientific hub for the development of strategies which may enable the application of these emerging technologies to their full potential in regulated bioanalysis.

The scientific programming will feature 19 symposia, 17 roundtables and mini-symposia, eight sunrise sessions, three short courses, two workshops and one brand new Advanced Immunogenicity training course.

ACBIO meeting

Discussing, Sharing perspectives, and Providing Potential Solutions on the Most Recent Issues in Bioanalysis

BABE-2012 is a scientific platform to meet fellow key decision makers all-around the Academic Institutions, Healthcare Institutes, Pharmaceutical, Biotech, CROs supply chain, Logistics practitioners making the congress a perfect platform to share experience, foster collaborations through the research talks & presentations to put forward many thought provoking strategies in Bioequivalence and Bioavailability, making the Congress a perfect platform to share proficiency.

Second symposium of the Japan Bioanalysis Forum

Regulations and Bioanalysis - update on new and emerging guidelines and update on Global harmonization 

Updates on the Progress of the GBC Harmonization Teams for Small and Large Molecules 

Updates on Global Harmonization of Bioanalytical Regulations and Activities of the Global Bioanalytical Consortium (GBC) 

GLOBAL BIOANALYSIS CONSORTIUM: Regulated Bioanalysis - A Proposed Global Harmonization Process 

Recent Activities of GBC through International Harmonization Teams (HT): Where We Are and What It Is Left To Do 

Global harmonization of BioAnalytical method validation 

GLOBAL BIOANALYSIS CONSORTIUM: Regulated Bioanalysis - A Proposed Global Harmonization Process 

Importance of a Globally Harmonized Guidance for both the Regulators and Practitioners of Bioanalysis and its main Characteristics 

Building the Global Bioanalysis Consortium - Working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation 

Towards Global Harmonisation 

Global Harmonization of Modern Bioanalytical Regulatory Practices 

Bioanalytical Procedures and Regulations: Towards Global Harmonization

Building the Global Bioanalysis Consortium – Working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation