The European Bioanalysis Forum wishes all her members, supporters, sponsors and conference attendees a wonderfull Christmas time and a splendid New Year
Wednesday, December 22, 2010
Tuesday, December 14, 2010
|Dr. Albert Wolthuis - The Blood Matrix: A Dynamic Mirror|
To select, view and/or download goto: http://bcn2010.europeanbioanalysisforum.eu/slides
Friday, November 26, 2010
(moderator Peter van Amsterdam, Abbott for EBF and GBC)
13.30 13.50 Philip Timmerman (Janssen Research and Development for EBF and GBC)
GBC-Harmonization Initiative and EBF Perspective
13.50 14.00 Michael Berntgen (EMA)
Update on EMA process
14.00 14.20 Jérôme Barré (afssaps)
EMA Perspective on Global Harmonization
14.20 14.40 Rafael Barrientos (Magabi for ACBio)
South America perspective
14.40 15.00 Daniel Tang (Frontage for BBDS and SBDS)
APAC Perspective on Global Harmonization
15.00 15.20 Mark Arnold (Bristol Meyers Squibb for AAPS)
AAPS Perspective on Global Harmonization
15.20 15.40 C.T. Viswanathan (FDA/CDER)
FDA Perspective on Global Harmonization
15.40 16.10 Panel Discussion
16.10 16.30 Coffee Break
Wednesday, November 17, 2010
A full listing of all posters including the floorplan and abstracts can be downloaded following this link.
Tuesday, November 16, 2010
Day 1 - 1 December 2010
08.30 08.40 Welcome and opening remarks
08.40 10.00 Bioanalysis – Thinking Outside the ”Commodity” Box
10.30 12.30 Practical Solutions to Bioanalytical Challenges : Blood - the original bioanalytical matrix?
13.30 16.00 Towards Global Harmonization
16.30 18.00 Pt Sponsor session I
18.30 20.00 Conference Reception I
Day 2 - 2 December 2010
08.30 10.00 Pt Sponsor session II
10.30 12.30 Technologies and Comparison of Assay Platforms
14.00 15.30 Reconnect on Dried Blood Spots
14.00 18.00 FDA Draft Guideline on "Assay Development for Immunogenicity Testing of Therapeutic Proteins" and Related Topics
16.00 18.00 Practical Solutions to Bioanalytical Challenges : Matrix Effects
18.30 20.00 Conference Reception II
Day 3 - 3 December 2010
08.30 10.30 Finding the Right Level
11.00 12.00 EBF Feedback
12.00 13.40 Biomarkers
13.45 14.00 Close out Discussion, Ideas for 2011
Thursday, November 11, 2010
Tuesday, November 9, 2010
Large Meets Small
Connecting strategies on analyzing large molecules with small molecule technologies
Monday, November 1, 2010
To view the meeting agenda go to:
For the 3rd European Bioanalysis Forum Open Symposium
e-Registration: € 350
On-site Registration: € 500
Thursday, October 21, 2010
To learn more about the GBC see our recent publication in Bioanalysis or visit our website at: http://www.globalbioanalysisconsortium.org/
Friday, October 15, 2010
Connecting analytical strategies for analysis of peptides and proteins
- New technology developments for the analysis of peptides and proteins
- Cutting edge analytical approaches
- Regulatory challenges
- Analytical strategies in choosing LBA versus chromatographic techniques
- Alternative technologies
Timing: June 2011
Tuesday, October 5, 2010
Wednesday, September 15, 2010
Thursday, August 19, 2010
Potential speakers, please use this form and submit your contribution to BCN2010@europeanbioanalysisforum.eu before 30 September.
- title of your presentation
- short biography (max 150 words)
- abstract (max 350 words)
Wednesday, August 18, 2010
Monday, August 2, 2010
Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum
The relationship between the exposure to drug metabolites and overall drug safety has become an integral part of the drug-development process. In-depth discussions in the scientific community, as well as recent guidelines on Drug Safety Testing of Metabolites from the US FDA (often referred to as the MIST guidance and ICH M3(R2) from the International Conference on Harmonization (ICH), has brought clarity to the regulatory requirements of the sponsor company in providing documentation on circulating levels of qualifying metabolites. However ....
Download full paper
Saturday, July 3, 2010
Potential speakers, please submit your contribution to BCN2010@europeanbioanalysisforum.eu
- title of your presentation (before September 30th 2010)
- abstract (250 words) (before October 30th 2009)
Friday, July 2, 2010
Poster submissions should make use of the attached form and be sent to firstname.lastname@example.org.
Key information to be provided: Title, Author(s), Company/organisation, Email of contact person, Category and an Abstract (250 words)
Tuesday, June 29, 2010
· Bioanalysis – thinking outside the ”commodity” box
· Practical Solutions to Bioanalytical Challenges
· Towards Global harmonization
· Platinum Sponsors session
· Conference dinner - evening speaker
· Technologies and comparison of assay platforms
· Breakout sessions
o Breakout Small molecules
o Guideline on "Assay Development for Immunogenicity Testing of Therapeutic Proteins" and related topics
o Practical Solutions to Bioanalytical Challenges: Matrix Effects
· EBF feedback on internal discussions
· Finding the right level
Saturday, June 19, 2010
- P. Timmerman (J&J, EBF) - The Use of Dried Blood Spots in Drug Discovery and Development: Overview and EBF’s Perspectives on Hurdles and Opportunities
- K. Beaumont (Pfizer) - Who Decided We Should Measure Plasma?
- F. Picard (Novartis) - An Overview of the Implementation of DBS At Novartis: Results and Next Step
- P. Wright (Pfizer) - DBS for Metabolite Identification: Can We ? Should We?
- C. Smith (AstraZeneca) - Metabonomic Analysis of Dried Biofluid (Blood, Plasma, Urine) Spots
- F. McClure (GSK) - Spot the Difference: Effect of TK Blood Sampling on Clinical Pathology Parameters
- L. Patrone (BMS) - Direct Comparison of DBS Analysis to Plasma and Whole Blood Analysis in Toxicokinetic Studies of Rats
- J. Burnett (Covance) - Practical Application of Dried Blood Spot Techniques in Toxicology
- M. Benton (Fulcrum Pharma) - QA Perspective on Dried Blood Spot Analysis
- P. Abu-Rabie (GSK) - Direct Quantitative Bioanalysis of Drugs in Dried Blood Spot Samples
- H. Ghobarah (AB Sciex) - High Sensitivity LC-MS/MS Quantification of Corticosteroids in Dried Blood Spots and Evaluation of Software Saturation Correction for Extending Dynamic Range
- M. Barfield (GSK) - the Use of Dried Plasma Spots (DPS) and Dried Urine Spots (DUS) for LC-MS/MS Assays
- A. Gajate Perez (Roche) - Can DBS Stabilize Ester Pro-Drugs and Glucuronide Metabolites?
- M. Hemsley (Covance) - Logistical Considerations and Experiences in Utilising Dried Blood Spots in Quantitative Bioanalysis
- A. Van Peer (J&J) - Blood and Plasma: A Magic Twin or Single in Human Pharmacokinetics?
- H. Pandya (Univ. of Leicester) - PK Studies in Infants and Children: Are Dried Blood Spots the Answer?
- L. Stolk (Univ. Maastricht) - Dried Blood Spot Methods in Therapeutic Drug Monitoring: Methods, Assays and Pitfalls
- T. de Boer (Xendo) - Extensive Utilisation of Dried Blood Spot Sampling in Early Clinical Development Studies: Pharmacokinetics, Pharmacogenomics and Safety Assessments
- B. Ooms (Spark Holland) - On-Line DBS-SPE-MS/MS. Feasibility of a Concept for Rapid DBS Analysis Without Punching
- G. Harland (Waters) - the Use of An Integrated Micro Fluidic LC-MS/MS Device for DBS Assays An Approach to Increased Sensitivity
- J. Dinan (BSD Robotics) - Bringing the DBS Advantage into the Laboratory
Friday, May 7, 2010
In December the EMA presented their draft Guideline on Validation of Bioanalytical Methods and already early spring 2010, two important workshops were held discussing this guideline in particular (joint EBF / EUFEPS workshop) but also global harmonization (CVG / Canadian LC-MS Group). Again, as in Barcelona in 2009, there was a clear consensus among the many participants at this latter meeting in Montreal to strive towards a harmonized guideline or white paper. EBF presented their views on the draft EMA guideline and a harmonization process at the Montreal meeting in: EBF Perspective on the New EMA Guidelines on Bioanalytical Method Validation (BMV) and input on global BMV harmonization
Next to these meetings there are also a number of relevant publications in the April issue of Bioanalysis dealing with this topic:
- Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis
Philip Timmerman, Steve Lowes, Douglas M Fast, Fabio Garofolo
- International harmonization of bioanalytical guidance
Surendra K Bansal, Mark Arnold, Fabio Garofolo
- Towards harmonized regulations for bioanalysis: moving forward!
Peter van Amsterdam, Berthold Lausecker, Silke Luedtke, Philip Timmerman, Margarete Brudny-Kloeppel
Wednesday, May 5, 2010
Monday, May 3, 2010
- DBS in the non regulated environment
- Combined poster & tutorial
- Combined toxicology & regulatory/QA aspects
- Bioanalytical & DBS: applications
- Clinical environment
- Bioanalytical & DBS: tools
The detailed final draft can be downloaded from the conference site.
Wednesday, April 28, 2010
Posters will have to be registered prior to the conference using the attached form to be submitted via email to email@example.com. The preferred abstract length is about 250 words. The workshop organisation may enforce trunkating of to extensive abstracts.
The supported poster format is Portrait.
For further information: DBS workshop website
Friday, April 23, 2010
Wednesday, April 21, 2010
Comments, suggestions, with respect to our 2nd open meeting can be entered either here on LinkedIn
Thursday, April 8, 2010
Friday, April 2, 2010
Positions 3, 4 and 5 plus a small contribution to number 1 on the of most downloaded articles list of Future Sciences' Journal: Bioanalysis.
Saturday, March 13, 2010
The European Bioanalysis Forum will be organising and co-organising 3 international meetings this year.
15 - 16 April, Brussels: "EMEA Draft Guideline on Validation of Bioanalytical Methods"
17 - 18 June, Brussels: EBF workshop "Connecting Strategies on Dried Blood Spots"
1 - 3 December, Barcelona: EBF 3rd Open Conference "From Challenges to Solutions"
Each of these three meetings have also been entered as an event on LinkedIn. Let your colleagues, peers and business partners know that you are attending one of more of these great meetings. To record your attendence or interest follow the links below:
EMEA draft BMV guideline: http://events.linkedin.com/EBF-EUFEPS-Workshop-EMEA-Draft-Guideline/pub/228867
Dried Blood Spots workshop: http://events.linkedin.com/EBF-Workshop-Connecting-Strategies-Dried/pub/228851
EBF 3rd Open conference: http://events.linkedin.com/EBF-3rd-Open-Conference-Challenges/pub/263783
Friday, March 12, 2010
Platinum sponsors will receive a presentation slot in the program. Other sponsors may participate in the general call for speakers.
Sponsor places are limited, sponsors who participated in 2009 will have a guaranteed slot in the 2010 conference on condition that they confirm sponsorship before April 15, after which spaces will be allocated on a first come first serve basis.
EBF will also reserve time for hospitality sessions within the programm which allows for more intense interactions. For further information or to sign up, please contact our conference manager, Christina Smith at firstname.lastname@example.org, telephone: +33 6 74 89 10 63.
Download: Call for Sponsors - 2010
The theme of the meeting is "From Challenges to Solutions" and will be held in Barcelona at the Hesperia Tower Conference Center from 1 – 3 December 2010
A dedicated conference site has been opened at: http://sites.google.com/site/ebf3open
Thursday, February 25, 2010
Organised by the:
EBF – European Bioanalysis Forum
EUFEPS – European Federation for Pharmaceutical Sciences
The Workshop will open on Thursday, April 15, at 09:00
and it closes on Friday, April 16, at 14:30.
Registration for this important event is now open. Follow the link in the attached pdf or visit one of the conference sites.
The workshop on the EMEA draft guideline is organized as an interactive meeting containing initial presentations by EMEA and EBF-EUFEPS representatives to each of the five sessions. In order to stimulate discussions the organizing committee is inviting participants to give session specific presentation of 10 min each (up to four for each session). The presentation should provide the view of the presenter or its organization on which behalf she/he is presenting on one of the topics discussed in this session and should preferentially be data based. The organizing committee decides on the base of the abstract if and to which session the presentation is accepted.
The prelimenary program and the 'call for speakers' is ready and available for viewing and/or downloading at the conference sites.
Our plans and ambitions for 2010, ongoing and new activities, were presented by the steering committee and discussed with the members during the January closed meeting in Hagenthal (Basel area) and are now released for publication. You can view and/or download the slide deck following this link.
Tuesday, February 23, 2010
The 2011 Forum will take place in cooperation with the European Bioanalysis Forum (EBF), ensuring this unique forum for bioanalysts to share and solve problems in an open and friendly manner continues into its fourth decade.
Friday, February 19, 2010
Next to the 'call for sponsors' and 'call for speakers' (see previous posts) a full detailed announcement of the meeting is now ready for viewing and download: final announcement
For further information see our dedicated site to this conference: http://sites.google.com/site/ebfdbs/
Conference email address: email@example.com
Tuesday, February 9, 2010
The presentations will need to be of a duration of 15 minutes. For each session, there a 4 presentation slots available, followed by a 20 minute panel discussion
Potential speakers, please submit to conference address: firstname.lastname@example.org
the title of your presentation (before March 31st 2010)
the abstract (250 words) (before April 30th 2010)
For further information see 'Call for Speakers' on our dedicated site to this conference: http://sites.google.com/site/ebfdbs/
The conference is organised as a non-profit event by EBF in collaboration with Bavalan Bioconference.
For further information on sponsorship please see the 'Call for Sponsors' and/or contact Christina Smith (email@example.com, telephone: +33 6 74 89 10 63).
EBF has opened a site dedicated to this conference: http://sites.google.com/site/ebfdbs/
Wednesday, February 3, 2010
EBF welcomed the chance the be able to provide input on this draft guideline and is proud of her EBF-IGM members for pulling this together in such a short time during the holiday period.
Tuesday, February 2, 2010
EMEA Draft Guideline on Validation of Bioanalytical Methods
April 15-16 • 2010 • Sheraton Hotel Brussels • Brussels • Belgium
The aim of this Workshop is to discuss the current scientific knowledge in the area of bioanalysis, the regulatory requirements and their subsequent translation into the work in the bioanalytical laboratory. Examples of topics to be discussed include the GLP-status of the process of method validation; acceptance criteria of methods to be used in the area of chromatography based and ligand-binding based assays; incurred sample reproducibility (ISR; study sample reanalysis for PK purposes; and re-integration, to list only a few).
The intention of this Workshop is to give scientists from industry and academia, managers and representatives of company regulatory functions the opportunity to discuss the new regulation with representative from regulatory authorities in Europe. Input for the Workshop Programme includes comments submitted to the organisers in the run-up phase to the event. All participants are invited to present their views and suggestions, based on own experience, during the discussion, and to support these proposals by experimental data.
The Workshop will open on Thursday, April 15, 2010, at 09:00, and it closes on Friday, April 16, 2010, at 14:30.
Friday, January 15, 2010
A DBS sub team of the European Bioanalysis Forum is moving forward with the preparations of holding a meeting focused on Dried Blood Spots. In this meeting EBF intends to bring together experts from all areas involved in this technique (Bioanalysis, Toxicology, Pharmacokinetics, Central labs, Regulatory authorities and Vendors) to connect and discuss the potential application of Dried Blood Spots in drug development.
Location: Sheraton Brussels Hotel, Belgium
Date: 17 - 18 June 2010
For future updates follow this newsletter or one of the following web sites:
EBF: http://www.e-b-f.eu/ Portal: http://sites.google.com/site/ebfdbs/
Thursday, January 14, 2010
EBF and EUFEPS are jointly setting up a conference to present and discuss the recently released draft guideline on Bionalytical Method Validation by the EMEA.
The meeting is scheduled for 15 - 16 April 2010 and will be held Brussels, Belgium.
For future updates follow this newsletter or one of the following web sites:
EBF: http://www.e-b-f.eu/ EUFEPS: http://www.eufeps.org/
Wednesday, January 13, 2010
The main purpose of this event is to Discuss, Review, Share Perspectives, Provide Potential Solutions and Agree upon a Consistent Approach on the Recent Issues in Regulated Bioanalysis.
The workshop will be held from April 22-23, 2010 in Montreal, Canada
Short Courses are on April 20-21, 2010 and the venue is the Hotel Marriott Chateau Champlain.
Detailed information can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php
Thursday, January 7, 2010
Tuesday, January 5, 2010
EMEA - http://www.emea.europa.eu/pdfs/human/ich/030295enfin.pdf
FDA - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf
ICH - http://www.ich.org/LOB/media/MEDIA503.pdf
Deadline for comments is February 2010
Monday, January 4, 2010
The meeting will be held in Brussels in the May/June 2010 timeframe
The meeting is scheduled for the third week in April and will be held in Brussels.
Further and more detailed information will follow by the end of January.
EMEA BMV: http://www.emea.europa.eu/pdfs/human/ewp/19221709en.pdf