EMEA Draft Guideline on Validation of Bioanalytical Methods

April 15-16 • 2010 • Sheraton Hotel Brussels • Brussels • Belgium

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.

http://sites.google.com/site/emeabmv/home
http://www.eufeps.org/document/con_brussels_apr10.html

EBF Outlook 2010

Within only a bit over 3 years EBF has become a well known and appreciated organisation. We are very happy with the achievements sofar, but are are also still quite ambitious to do more.

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.

Mark Your Diaries: Reid International Bioanalytical Forum

The next Reid International Bioanalytical Forum will take place from 4- 7 July 2011 at the University of Surrey, Guildford, UK.

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.

Connecting Strategies on Dried Blood Spots

The EBF workshop on Dried Blood Spots - 17-18 June in Brussels - is reaching the final stages of the setting-up phase.

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: dbs.brussels.2010@gmail.com

EBF DBS meeting: Call for Speakers

EBF welcomes stimulating speakers to the symposium.

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: dbs.brussels.2010@gmail.com

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/

EBF DBS meeting: Call for Sponsors

Following the success of the 1st and 2nd open symposia with over 400 participants at the 2009 conference the EBF is pleased to announce another important meeting open for sponsoring. This is in addition to the 3rd Open symposium (1-3 December in Barcelona, Spain) for which a separate call for sponsors will go out.
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 (contact@bioanalysis-forum.com, telephone: +33 6 74 89 10 63).

EBF has opened a site dedicated to this conference: http://sites.google.com/site/ebfdbs/

FDA Immunogenicity Testing Draft Guideline

EBF-IGM collected, evaluated and merged the comments from her member companies on the "FDA Draft Guidance: Assay Development for Immunogenicity Testing of Therapeutic Proteins" into one consolidated document. This 24 page document was uploaded to the regulations.gov site (docket FDA-2009-D-0539) on Saturday 30 January and can be assessed via this link.

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.

EBF & EUFEPS workshop on Bioanalytical Method Validation

EMEA Draft Guideline on Validation of Bioanalytical Methods

April 15-16 • 2010 • Sheraton Hotel Brussels • Brussels • Belgium

Organised by the:
EBF – The European Bioanalysis Forum and
EUFEPS – European Federation for Pharmaceutical Sciences

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.

For further information download the announcement, check the conference portal or go to one of the websites of the organisers.