Wednesday, December 22, 2010

Season's Greetings


The European Bioanalysis Forum wishes all her members, supporters, sponsors and conference attendees a wonderfull Christmas time and a splendid New Year

Tuesday, December 14, 2010

EBF 3rd Open Barcelona Conference: Download Slide Decks

Dr. Albert Wolthuis - The Blood Matrix: A Dynamic Mirror
PDF renditions of the slide decks of the oral presentations have been made available on the EBF Barcelona 2010 conference site.

To select, view and/or download goto: http://bcn2010.europeanbioanalysisforum.eu/slides

Friday, November 26, 2010

EBF 2010 Barcelona: Update Harmonization Session

13.30 16.00 Towards Global Harmonization
                   (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

EBF 2010 Barcelona Symposium: Final Posters List Available

The 2010 EBF open Barcelona symposium "From Challenges to Solutions" has attracted 80 posters which will be presented in the Exposition hall and be available for viewing during the entire conference.

A full listing of all posters including the floorplan and abstracts can be downloaded following this link.

Tuesday, November 16, 2010

Final Day by Day Agenda EBF's 3rd Open Symposium

View or download the final agenda of the 2010 Barcelona Symposium of the European Bioanalysis Forum.

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

Mark your Calendars! EBF 2011 Focus Meeting


Large Meets Small


Connecting strategies on analyzing large molecules with small molecule technologies

June 21-22 2011
Sheraton Brussels Hotel
Brussels, Belgium


Monday, November 1, 2010

EBF 2010 Barcelona Symposium: Last Call For Posters !


There is still time to submit poster presentations for the 3rd EBF Open Symposium

Submission of posters is open until 15th November 2010, to submit go to:
http://bcn2010.europeanbioanalysisforum.eu/posters


To view the meeting agenda go to:
http://bcn2010.europeanbioanalysisforum.eu/agenda

Join us in Barcelona, Spain - 1st to 3rd of December 2010
For the 3rd European Bioanalysis Forum Open Symposium


e-Registration: € 350
On-site Registration: € 500


http://bcn2010.europeanbioanalysisforum.eu/registration

Thursday, October 21, 2010

GBC Website Live!

The Global Bioanalysis Consortium (GBC) was founded in 2010 by Douglas Fast, Eric Woolf, Fabio Garofolo, Mark Arnold, Peter van Amsterdam, Philip Timmerman, Steve Lowes and Surendra Bansal and is a world wide organisation consisting of representatives of scientific associations with the mission to harmonize and merge existing or emerging bioanalytical guidances to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.

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

First Announcement: EBF Focus Meeting: Large meets Small

EBF Focus Symposium: Large meets Small
Connecting analytical strategies for analysis of peptides and proteins

Topics:
  • 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
Venue: Sheraton Brussels
Timing: June 2011

Wednesday, September 15, 2010

European Bioanalysis Forum on Facebook

EBF has opened a Facebook page where it will present its meetings and announcements. Interested bioanalytical scientists are invited to connect. Check out the EBF Facebook pages.

Thursday, August 19, 2010

Last Call for Speakers

Again this year, EBF welcomes stimulating speakers to the symposium.

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)

Please identify the session in which you plan to contribute. See also the Program. Depending on the topic, your presentation may be assigned to the plenary lectures or to a breakout session.

Advertise the EBF meeting




This announcement of the 2010 EBF meeting shown above can be downloaded as PDF using this link.

Wednesday, August 18, 2010

Update on Barcelona 2010 conference program

The draft program of the third open EBF meeting "From Challenges to Solutions", 1 - 3 December 2010 in Barcelona, Spain has been updated and is availble for viewing and download (attached to this announcement). Future updates will be announced on this page and also presented on the Program page of the Conference website.

Monday, August 2, 2010

EBF MIST White Paper

An EBF team consisting of: Philip Timmerman, Morten Anders Kall, Ben Gordon, Sirpa Laakso, Achim Freisleben and Richard Hucker‌has published EBF's views on the impact of the MIST guidance on the bioanalytical laboratory.

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 ....
Read more
Download full paper

Saturday, July 3, 2010

BCN 2010 - Call for Speakers

Again this year, EBF welcomes stimulating speakers to the symposium.
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)
Please identify the session in which you plan to contribute. See also the conference program. Depending on the topic, your presentation may be assigned to the plenary lectures or to a breakout session.

Friday, July 2, 2010

BCN 2010 - Call for Posters

EBF will welcome scientific poster presentations at her third open conference "From Challenges to Solutions" and researchers are encouraged to present their work at our meeting.

Poster submissions should make use of the attached form and be sent to contact@bioanalysis-forum.com.

Key information to be provided: Title, Author(s), Company/organisation, Email of contact person, Category and an Abstract (250 words)

Tuesday, June 29, 2010

Prelimenary Program EBF 3rd Open Barcelona Meeting

The draft program for this years EBF open meeting "From Challenges to Solutions" 1-3 December 2010, Barcelona, Spain has been published on the dedicated conference site and may also be downloaded following this link. In short the conference program has sessions on the following topics:

· 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
· Biomarkers

Saturday, June 19, 2010

Download EBF DBS workshop presentations

PDF renditions of all the 21 the powerpoint presentations given at EBF's workshop on Connecting Strategies on Dried Blood Spots have been uploaded to the dedicated workshop site and can be viewed and downloaded from this page.


Plenary Session
  • 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
DBS in the Non Regulated Environment
  • 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
Combined Toxicology/Regulatory/QA
  • 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
Bioanalytical and DBS: Applications
  • 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
Clinical Environment
  • 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
Bioanalytical and DBS: Tools
  • 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

Harmonization of Bioanalytical Method Validation guidances

When the EMA (formerly known as EMEA) presented it's concept paper on the need of a bioanalytical method validation guideline, the bioanalytical community was worried about the consequences of having multiple, potentially contradicting, guidelines from major economies. This lead to the strong feeling to move towards the direction of harmonization of BMV guidelines, basically to come to one guideline. This wish was clearly expressed by the hundreds of attendees at the EBF 2nd open conference in Barcelona last year.

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:
An idea that was seeded at the Barcelona 2009 meeting: set-up an international group to foster and manage processes towards harmonization of BMV guidances, was extensively discussed and further developed at the Montreal CVG meeting. A group named 'Global BMV Consortium (GBC)' with representatives of AAPS, APA, CVG and EBF is being set-up for this purpose. The GBC would like to get a number of representatives from international BA organisations from other continents then North America and Europe on board and is reaching out to identify key organizations that represent the bioanalytical community in their region/continent in accordance with the current 4 founding members. It is the intention to publish the activities of this group at one or a few websites.

Wednesday, May 5, 2010

Dried Blood Spots

Bioanalysis and Dried Blood Spots (DBS) first entered the agenda of EBF in June 2008 and has been repeatedly discussed ever since that first presentation in Basel. There was a full conference session dedicated to DBS during the 2009 open EBF conference in Barcelona and a one and a 3/4 day workshop is currently in preparation. For more information on this workshop in Brussels check out EBF's dedicated DBS conference webpages.

Monday, May 3, 2010

Final Draft Program DBS Workshop

The program of this two day EBF workshop in Brussels on the value and use of Dried Blood Spots is approaching its completion. The meeting will start at 8:30 on Thursday 17 June and will close at 14:30 on Friday 18 June.

Sessions:
- 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

EBF DBS workshop: Call for Posters

There is still room for a good number of posters at the June "Connecting Strategies on Dried Blood Spots" workshop and EBF welcomes bioanalists, clinicans, toxicologists, pharmacokineticists, regulators, instrument developers and vendors, blood spot collection paper developers and vendors to present their work.

Posters will have to be registered prior to the conference using the attached form to be submitted via email to contact@bioanalysis-forum.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

Slide decks of EBF/EUFEPS workshop made available

The presentations of last week's EBF / EUFEPS workshop on the EMA bioanalytical method validation guideline are available for download at: http://www.eufeps.org/spring10041516.html

Wednesday, April 21, 2010

Conference report of 2nd open meeting

The conference report on EBF's second open meeting "The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis" has been published in this month's issue of Bioanalysis and is available for a free download.

Comments, suggestions, with respect to our 2nd open meeting can be entered either here on LinkedIn

Thursday, April 8, 2010

Preliminary Program EBF Dried Blood Spots Workshop

The draft program for the DBS workshop has been published on the conference website "Connecting Strategies on Dried Blood Spots" and can also be downloaded as a PDF formatted file via this link.

Friday, April 2, 2010

Impact

EBF as a young organisation is pretty proud of the increasing attention it receives from the bioanalytical community. The exponential growth of the number of attendees to the open Barcelona meetings is a clear marker for that. Another one is the interest bioanalists show in EBF publications.

http://www.future-science.com/action/showMostReadArticles?journalCode=bio

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

EBF meetings on LinkedIn events

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

EBF 3rd Open: Call for Sponsors

Again this year, EBF will welcome Platinum and Gold Sponsors, in line with the 2009 conference.

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 bavalan.bioconference@gmail.com, telephone: +33 6 74 89 10 63.

Download: Call for Sponsors - 2010

Mark Your Diaries: EBF 3rd Open Conference

Over 400 participants contributed to the success of the 2nd EBF Open Symposium in Barcelona December. 2009. Again for this year, EBF would like to announce their Open Symposium.

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

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.

Tuesday, February 23, 2010

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.

Friday, February 19, 2010

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

Tuesday, February 9, 2010

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/

Wednesday, February 3, 2010

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.

Tuesday, February 2, 2010

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.

Friday, January 15, 2010

EBF meeting on DBS in drug development

Announcement / Update

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-EUFEPS meeting on draft EMEA guidance on BMV

Announcement / Update

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/
Flyer: http://sites.google.com/site/emeabmv/home


Wednesday, January 13, 2010

4th Workshop on Recent Issues in Regulated Bioanalysis

In continuation of 2007 - 2009 workshops, the 4th Regulated Bioanalysis Workshop (Montreal April 21-23 2010) will discuss Global Harmonization of Bioanalytical Method Validation (BMV) and Sample Analysis Guidelines with 5 major Worldwide Regulatory Agencies: US FDA, UK MHRA, Brazil ANVISA, Europe EMEA guideline representative, and Health Canada representative.

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

Addendum to ICH S6

The addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals has been published and is open for comments. The document can be downloaded from:

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

Dried Blood Spots

An EBF-DBS sub team is preparing 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. More details will follow soon

The meeting will be held in Brussels in the May/June 2010 timeframe

EBF-EUFEPS-EMEA meeting

EBF will together with the EUFEPS be organising a meeting on EMEA draft guidance on bioanalytical method validation.

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.

Links:

EBF: http://www.e-b-f.eu/conferences.php
EUFEPS: http://www.eufeps.org
EMEA BMV: http://www.emea.europa.eu/pdfs/human/ewp/19221709en.pdf