Friday, May 31, 2013

EBF Newsletter Vol. 2, No. 2


The second newsletter of 2013 is out. In this issue:
  • Conference News: 
    • 6th Open Symposium 
    • Focus workshops 
  • Presentations & Publications 
    • NC3R Forum 
    • JPAG-DMDG meeting 
    • EMA guideline on BMV 
    • Reid Bioanalytical Forum 
    • AMS validation 
    • GBC webinars 
  • Guidelines 
  • Calendar of Events 

Friday, May 3, 2013

EBF 6th Open Symposium - Call for Speakers - Deadline 26 May


EBF 6th Open Symposium

Moving Forward Together
Science, Technology and Regulations Embracing New Paradigms
20th – 22nd November 2013, Hesperia Tower, Barcelona, Spain

2nd CALL FOR SPEAKERS
In comparison to previous years, the deadlines for submission have changed significantly. Speakers are requested to submit their contribution to open@europeanbioanalysisforum.eu, before May 26th 2013, providing the title of the presentation, a recent bio (max 150 words) and an abstract (max 350 words). You can find detailed instructions on: http://bcn2013.europeanbioanalysisforum.eu/Speakers/. It is our intention to publish the detailed conference agenda before the summer.
Planned sessions for the 2013 EBF Open Symposium are:
  • ·       Assay transfer - Expectations & Practicalities
  • ·       Interpretation and implementation of Guidance
  • ·       From biomarker to diagnostics or personalized medicine: is there a role for regulated bioanalysis?
  • ·       Consult the doctor: lessons learned session from where we failed… or not.
  • ·       Is validation really needed for all assays: taking tiered approach outside the world of MIST
  • ·       Interpretation and implementation of Guidance expectations:  Internal Standard variability, carry-over
  • ·       Emerging Technologies in sampling & extraction: microsampling and development in sample preparation
  • ·       Emerging Technologies in separation & quantification: miniaturization in LC and MS
  • ·       Challenges in the analysis of antibody-drug conjugates (ADCs)
  • ·       Challenges for Flow Cytometry in regulated Bioanalysis
  • ·       Surprises in Ligand Binding Assay method development
  • ·       Analysis of parallelism for biomarkers and therapeutic proteins
  • ·       Promises of new technology: sense and nonsense of HR-MS
  • ·       Challenges and solutions of sample logistics
  • ·       Interferences in LBA

Please check our website to see a full list of program topics: http://bcn2013.europeanbioanalysisforum.eu/Program/.
We anticipate bringing an exciting program and candid discussions and in the spirit of a true Forum, we will build the agenda reflecting your interest, contributions and engagement.

POSTERS

We would also like to invite you to register your posters. Please submit your poster contribution (before September 15th 2013) to open@europeanbioanalysisforum.eu using the poster registration form at: http://bcn2013.europeanbioanalysisforum.eu/Posters/

Wednesday, May 1, 2013

Global Bioanalysis Consortium Webinars


Outcomes of the GBC Harmonization Teams on
Bioanalytical Method Validation
The GBC announces two Webinars presenting key recommendations from the Harmonization Teams.  The Harmonization teams were grouped under broad categories of topics related to 1) all chemotypes, 2) chromatographic-based assays and 3) Ligand-binding assays.  To minimize the number of webinars most attendees are interested in, the topics for all chemotypes have been grouped with both the chromatographic assays and ligand-binding assay content producing just two sessions.  Each Webinar session will be presented twice to accommodate all regions

Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation