Program Update EBF 6th Open Symposium

PROGRAM CHANGE

6^th EBF Open Symposium

Moving Forward Together

Science, Technology and Regulations Embracing New Paradigms

20^th – 22^nd Nov 2013

Hesperia Tower, Barcelona, Spain

We have revised the agenda of the 6th EBF Open Symposiumto 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^nd Nov from 11h00 onwards. The session will consist of a short introduction summarizing the EBF consolidated comments on the draft Guidance (per Guidance chapter), followed by interactive plenary discussions.

Your active contribution is welcomed.

To minimize the impact on the symposium program, we rescheduled the Friday plenary sessions into Friday morning breakout session (‘HR/MS’ and ‘Issues & solutions in sample logistics’) or a Thursday Spotlight workshop (‘tiered approach’)

Our website is being updated to reflect the changes

REGISTER NOW

  

On line registration closes on November 15^th

After this date, only on-site registration is possible

AAPS Workshop on: Quantitative Bioanalytical Methods Validation and Implementation: The 2013 Revised FDA Guidance

The long awaited FDA draft update of the Bioanalytical Method Validation guidance has been published on the FDA website and the AAPS is organizing a workshop to discuss the draft document at the Baltimore Hilton from December 3 - 5.

Go to http://www.aaps.org/BMV/ for further information and to register.

EBF will sent its full Steering Committee to attend this important workshop and we are very much looking forward to meet our colleagues from all over the world.

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 

Click here to read/download the newsletter

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

EBF 6^th Open Symposium

Moving Forward Together

Science, Technology and Regulations Embracing New Paradigms

20^th – 22^nd November 2013, Hesperia Tower, Barcelona, Spain

2^nd 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 26^th 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 15^th 2013) to open@europeanbioanalysisforum.eu using the poster registration form at: http://bcn2013.europeanbioanalysisforum.eu/Posters/

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

Moving Forward Together: First Call for Speakers

6th Open Symposium Moving Forward Together

Science, Technology and Regulations Embracing New Paradigms

Date: 20^th – 22^nd November 2013

Hesperia Tower, Barcelona, Spain

With already five great Barcelona Symposia behind us, the EBF Organizing Committee is ready to share the program outline of the 6^th Open Symposium: MOVING FORWARD TOGETHER. Hence, we announce our

1^st CALL FOR SPEAKERS

This year we identified 4 major themes where we want to move forward together:

• ·       Regulations
• ·       Technology and process improvement
• ·        Increasing the added value of connectivity outside Bioanalysis
• ·       The impact of new technologies, strategies and requirements on our day-to-day executing of bioanalysis.

For each of these themes we identified a number of program topics from which we will build the sessions. 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. Depending on your submissions, some program topics will become stand-alone sessions, others will be integrated into dedicated theme sessions or workshops. In the spirit of a true Forum, we plan to build the agenda reflecting your interest, contributions and engagement.

ORAL PRESENTATIONS

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 26^th 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/. We intend to publish the agenda before summer.

POSTERS

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

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	Meeting Organisation Richard Abbott (Shire), Begona Barroso (Astellas), Magnus Knutsson (Ferring), Steve White (GSK), Peter van Amsterdam (Abbott), Margarete Brudny-Kloeppel (Bayer Healthcare), Arjen Companjen (Crucell), Michaela Golob (Merck-Serono), Benno Ingelse (MSD) and Philip Timmerman (Janssen R&D)
SPONSOR RELATIONS, MARKETING AND LOGISTICS: Christina Smith, Bavalan Bioconference SARL The conference is organised as a non-profit event on behalf of the EBF vzw . The organisation of the conference is independent of all EBF member companies and conference sponsors.