ecopa - european consensus-platform for alternatives
X-mas edition - December 23, 2008, edition #18-2008
Dear ecopa messenger subscriber,

As usually, year’s end held a lot of interesting news for alternatives. Besides of the Annual Meeting of epaa on Nov. 3 (report just out) and the almost parallel release of the draft novel of Directive 86/609 by the Commission, ecopa had its Annual Meeting addressing deadlines in the EU. This was introduced by Dir (DG ENT) and current EU Commission co-chair of epaa, Georgette Lalis’ overview of the EU Commissions view and procedures regarding ongoing 3R-activities. The remaining sessions of the meeting were held as lively discussions. It became apparent that esp. issues such as “waiving of requested animal testing” like in Annex XI of REACH will be a topic (all presentations here). This year’s Annual was attended by more than 60 people!
Website Presentations of the 9th Annual ecopa Workshop

Also, the minutes of the Stockholm ecopa Board Meeting of Sept. 25, 2008, the presentations and photos of this year’s eSI-meeting, organized together with epaa under the heading "Recent developments and potentially novel approaches of science to alternative testing of cosmetics and pharmaceuticals” are to be found in this newsletter edition.
Website Presentations of the eSI Meeting
Website Photos of the eSI Meeting

By now, ecopa is raising attention in the life science-media as well: e.g. in the Euro Biotech News, both last editions, since ecopa has been contributing to epaa and its mirror and working groups, but especially as it is contributing in kind, (in regard to alternative method dissemination to EU-FP 6/7-projects); therefore, ecopa is currently also part of 2 submissions to the most recent HEALTH call of the FP7.

The forthcoming year 2009 will be a challenging year for ecopa, with its intensified activities and major workshops in its START-UP-project, but also due to the fact that a major part of the ecopa-Board will terminate their tenure with the next Annual in November 2009.

Let me wish you a merry festive season, a peaceful Christmas, and a healthy and good New Year

Bernward Garthoff
Treasurer ecopa on behalf of the ecopa Management Board

P.S.: Any proposal or recommendation regarding style, content or distribution of the newsletter is highly welcome and appreciated ( If you know other people or institutions interested, have them visit our website and subscribe to this newsletter.
ecopa Issue # 18 (December 2008) top
I. ecopa:
I.1 General News
    1.1 News on REACH and GHS
    1.2 EU Partnership (EPAA)
    1.3 Innovative Medicines Iniative (IMI)
I.2 Other News (Miscellaneous)
    2.1 Nanotech
    2.2 Review of Directive 86/609

II. EU 6th and 7th Framework Programme Projects / ecopa Working Groups / Platforms:
II.1 EU 6th and 7th Framework Programme Projects / ecopa Working Groups
    1.1 Framework Projects / Platforms
    1.2 ReProTect
    1.3 ACute Tox
    1.4 Sens-it-iv
    1.5 BioSim
    1.6 Liintop
    1.7 carcinoGENOMICS
II.2 EU 7th Framework Programme Projects, Initiatives and Technology Platforms
    2.1 SusChem
    2.2 Regulations of the 7th Framework Programme
    2.3 START-UP
    2.4 ESNATS

III. Miscellaneous:
III.1 Events
    1.1 ecopa events
    1.2 Other events
III.2 Awards, Publications, Newsletters
III.3 Calls and Vacancies
III.4 Varia
ecopa I.1. General News top
I.1.1. Recent News on REACH and GHS

First REACH list of dangerous chemicals agreed:
Website article-176244

EU Member States approve world-wide rules for labelling of chemicals

The European Commission welcomes the agreement by the EU Member States to align EU legislation on classification, labelling and packaging of substances and mixtures to the United Nations Globally Harmonised System (GHS). This new system will ensure that the same hazards will be described and labelled in the same way all around the world. By using internationally agreed classification criteria and labelling elements, it is expected to facilitate trade and to contribute towards global efforts to protect humans and the environment from hazardous effects of chemicals. The new regulation will complement the REACH regulation on the registration, evaluation, authorisation and restriction of chemicals. The European Parliament already the 3rd of September this year approved the GHS regulation. The next step will be its publication in the Official Journal.

The regulation will require companies to classify, label and package appropriately their hazardous chemicals before placing them on the market. It aims to protect workers, consumers and the environment by means of labelling which reflects possible hazardous effects of the chemical, while also taking over from REACH notification of classifications to the European Chemicals Agency (ECHA) in Helsinki.

The regulation will after a transitional period replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC) and mixtures (Directive 1999/45/EC). After entry into force, the deadline for substance classification according to the new rules will be 1 December 2010 and for mixtures 1 June 2015.

More information about the new rules can be found under:
ECHA ECHA (European Chemical Agency) top
European Chemicals Agency is operational

European Chemicals Agency (ECHA) runs the REACH-IT portal.

More information here:
Access to REACH-IT portal:

ECHA held its first stakeholder’s day on October 10, 2008. The outcome is published here:

General information and more events by ECHA, related to REACH, see the website:
EPAA top
I.1.2. European Partnership on Alternative Approaches to Animal Testing (EPAA)

For outcome of the recent Mirror Group meetings and the last workshops, see the epaa-website:

EPAA-newsletter of November 2008 is published and can be read here:
Adobe PDF


Progress report 2008 published:
Website 2_progress_reports/epaa_report_final_081020.pdf

EPAA-events are listed under:

This year’s annual meeting has taken place on November 3, 2008 in Brussels. Topic in 2008 was “3 Rs - Research”, the title being: "Research into alternative approaches (3Rs) in regulatory testing: Are we on the right track?". The 3Rs Declaration can be found here:

The Mirror Group of stakeholders including the EP, animal welfare organizations (until recently), institutions and patient groups ecopa is represented by four of it’s members. Next meeting of the Mirror Group will most likely be in spring of 2009.

The EPAA Communication Group presents their new website:

It is said to have become clearer, more easily accessible and user-friendly. EPAA Communication Group is interested in opinions and would welcome any feedback.

Eurogroup has withdrawn from EPAA:
Eurogroup for animals has decided to withdraw from the European Partnership on Alternative Approaches (EPAA) after receiving word that the European Commission had yet again delayed the publication of the proposal for new legislation on the protection of research animals.

Eurogroups letter to the Commission:
IMI top
I.1.3. IMI is launched

The Innovative Medicines Iniative (IMI) has been launched on April 30, 2008. This is an initiative launched by both the European Commission and the EFPIA, the European Federation of Pharmaceutical Industry Associations. The goal of this initiative is to give an impulse to biopharmaceutical innovation in Europe. Universities, hospitals and public institutions can get financing for a research project.

IMI organises annual calls to be participated by academia and small companies. The subjects are determined by the EFPIA in cooperation with the European Commission. The first calls are out by now.

IMI First Call for proposals: Stage 2
• Open 23 October 2008 - 20 January 2009
• One Full Project Proposal per Topic
• Merger of the best Applicant Consortium and the EFPIA Consortium for each Topic
• Expert recommendations in the Evaluation Consensus Form must be taken into account for the Full Project Proposal
• Evaluation by independent experts February- beginning March 2009

More information can be found here:
Adobe PDF
ecopa I.2. Other News top
I.2.1. Nanotech

The US Environmental Protection Agency (EPA) and its Science Policy Council has issued a nanotechnology white paper. The paper is aimed at providing information on the science issues and needs associated with nanotechnology, and to communicate them to stakeholders and the public.


Chronology up to now: February 2008: Commission's Scientific Committee on Consumer Products (SCCP) published its opinion on "Safety of nanomaterials in cosmetic products".

See resp. paper here:
Adobe PDF

June 17, 2008: The Commission was expected to publish a regulatory review to establish whether new legislation on nanomaterials is needed.

Early 2008: Establishment of an observatory to carry out dynamic assessments of nanotechnology development, use and scientific market developments, providing an 'early warning' system for the EU institutions and member states.

By July 2008: The European Food Safety Authority (EFSA) publishes its general opinion on the potential risks of the use of nanotechnologies in the food sector. After that, the opinion will be submitted for public consultation

I.2.2. Review of Directive 86/609

The new version, as of September 2008, finally is out, since November 5th, 2008, and currently being discussed in the member states. Article 44-46 in chapter V address alternatives specifically. See more under III.2.13.
Progress can be followed under:
ecopa II.1. EU 6th Framework Programme Projects / ecopa Working Groups top
II.1.1.1. Recent News on FP6 and FP7 projects

Next Board Meetings scheduled (addressing also the START-UP project):

- February 25, 2009
- October 1, 2009

Representatives of ecopa in EU projects 6th Framework Programme:
SSA project ForInViTox (Forum for researchers and regulators to meet manufacturers of toxicology test methods) - ecopa is represented by Dr. Odile De Silva.
BioSim – Flavia Zucco represents ecopa in this EU Project.
CarcinoGENOMICS – Bernward Garthoff is the ecopa representative in this IP FP6 project. ecopa has taken over the Work Package of dissemination of results of the consortium.
A questionnaire of the WP 11 regulatory group can be found on the carcinoGENOMICS website for consultation and input.
Input is requested and welcome from representatives of regulators, authorities, agencies and especially from toxicologists in industry and academia.
ACute Tox – Peter Maier is the representative in the Advisory Board.
Sens-it-iv – Vera Rogiers (represented by the ecopa secretariate) is the representative in the Advisory Board, and ecopa is seconding in the dissemination of results.
PREDICTOMICS – Bernward Garthoff was the representative in the Advisory Board, the project has been finalized.
Liintop – Horst Spielmann is the representative in the Advisory Board.
ReProTect – Karin Gabrielson, Vera Rogiers and Bernward Garthoff (Chair) are representatives on the Supervising Board, and ecopa is seconding in the dissemination of results.
START-UP START-UP is the ecopa-follow-up-project for CONAM.
ESNATS - ecopa is lead part of the dissemination workpackage.
ecopa – latest ecopa-Board meeting took place on September 25, 2008 in Stockholm. The minutes of the Stockholm ecopa Board Meeting you can get here.

The European Commission has published a booklet on all European FP6-projects concerned with alternative testing.

You can download it from this link:
Adobe Reader PDF

II.1.1.2. Platforms

II. Austrian Platform
» z e t – Austrian Centre for Alternative and Complementary Methods to Animal Testing

The 15th Linz-congress has taken place on September 19-21, 2008.

II. Belgian Platform
» Foundation Prince Laurent

II. Czech Platform

II. Danish Platform

II. Dutch Platform
» NCA - The Netherlands Centre Alternatives to Animal Use

Adobe PDF PDF: Latest issue of the NCA newsletter, published on November 25, 2008

II. Finnish Platform
» Fincopa

A new board has been elected in Fincopa. The chair will be from now on Kirsi Vähäkangas, from the University of Kuopio, the position of vice chair will be taken by Tuula Heinonen, from the University of Tampere and Eila Kaliste, from the State Provincial Office of Southern Finland will be secretary. The treasurer still is Marianna Norring, from the University of Helsinki. Other members are: Päivi Alajuuma, Hannele Huuskonen and Helinä Ylisirniö. The vice members are: Immo Rantala, Heidi Diallo, Marika Mannerström, Paula Vesa, Christina Björklund, Kati Pulli and Paula Hirsjärvi.
Fincopa ‘s website:

II. French Platform
» Plateforme Nationale pour le développement des Méthodes alternatives à l’experimentation animale

The French Platform was mentioned in the “European Biotechnology Journal” (no 5-6, volume 7, 2008) with an article. The title of the article is “Alliance to decrease animal tests”. It mentions that the platform is raised by the French research ministry and the country’s national medicines regulator (Afssaps). It also mentions that the French Platform is part of the ecopa-umbrella.

II. German Platform
» Stiftung set

The Annual Report for 2007 has been approved by the council on June 13, 2007 and is to be found on the website of set soon. The German version will be up first, it can be found on the first page, under ‘Downloads’, click on ‘Tätigkeitsbericht 2007’.

On the homepage of the website, set offensively asks scientists to refer to the set’s sponsoring programme and hand in scientific applications.

Adobe Reader PDF PDF: set Activity Report (76 kb)

II. Hungarian Platform
» Hucopa

The new executive Board has been elected:
It consists of Lajos Balogh, chair, Eva Hercsuth, heading the Animal welfare platform, Prof Tibor Bartha, heading the Academy, Laszlo Pallos, Authority Zsuzsa Somfai, Industry.

In context with the forthcoming START-UP event in Budapest in October 2009 addressing Replacement, jointly organized by the Hungarian and the German Platform, there will be a local Hucopa-event taking place as well.

II. Italian Platform
» IPAM - Italian Platform on Alternative Methods

Adobe Reader PDF PDF: IPAM annual report 2006 (5 kb)

II. Irish Platform

II. Norwegian Platform
» Norecopa

Norecopa, Norway’s National Platform for Alternatives to Animal Research, celebrated its first birthday on 10th October 2008.
Norecopa’s website, which contains a calendar of events, in Norwegian language with an overview page in English, can be reached here:

II. Polish Platform
» Polcopa

II. Spanish Platform
» REMA – Red Española para el Desarrollo de Métodos Alternativos a la Experimentación Animal

REMA has organized a meeting in parallel with the START-UP-expert meeting in Madrid in May. This meeting took place in the building of the Ministry of Health.
The REMA activities can be found can at (Spanish version):

II. Swedish Platform
» Swecopa

Government support for 3Rs research
The Swedish government has promised an increase in funding for 3Rs alternatives: 13 million SEK in 2009 instead of the 8 millions that was allocated in 2008. This is still far from the 18,5 millions that was allocated in 2006, but a step in the right direction compared to the decreases faced in the last 2 years.
News from Swecopa is published on the website under “News”. A newsletter in Swedish is also available at
E-mail us at if you want to receive the newsletter.

II. Swiss Platform
» 3R Research Foundation Switzerland

The well-designed website of the Swiss Platform contains recent information on activities, events and developments.

Latest bulletin of October 2008 “An in-vitro system for detecting the health effects of inhaled particles and gases” to be found here:

Interested to form a new national platform in your country?
Please contact us (» contact section).

For an upfront info how to create a platform in your country, and which criteria to apply? See also the presentation of Jose Castell at the Stakeholder Workshop in Prague ECVAM/ecopa Stakeholder Workshop:
Adobe Reader PDF PDF: A guided tour to become full members/associate members in ecopa (200 kb)
All the abstracts of the following projects are to be found on the forum of the ecopa website, see the comment under II.1.
ReProTect top
II.1.2. ReProTect

This 6th FP-project, that ecopa had co-initiated and in which ecopa is represented with 3 members in the Supervising Board including the Chairperson, was started in 2003 with 21 partners.

The overall funding is scheduled to be 9.1 mio EUR, resp. 13.5 mio EUR. Contract with the EU was signed on July 1, 2004; the administration is performed by Prof. Michael Schwarz, University of Tübingen.

II.1.2.1. Recent News

The latest Supervising Board Meeting was held on July 8, 2008 in Dresden, Germany.

The Joint Annual Research Area meeting (November 27-28, 2008) and a Meeting on further ‘strategic’ planning (November 26-27, 2008) were held at Ispra, Italy at ECVAM. A brochure on the ongoing activities within ReProTect is available.
Adobe Reader PDF PDF: ReProTect Brochure

Adobe Reader PDF PDF: Executive Summary (224 kb)

Also, please find a respective flyer below, and the brochure with first results.
Adobe Reader PDF PDF: ReProTect Flyer (320 kb)

ecopa is involved in the Board and the results dissemination.
ACute Tox top
II.1.3. ACute Tox

II.1.3.1. Recent News

A list of all publications produced by the Consortium is available on the web site as well as the project structure and a profound overview. Link below.

The latest newsletter as of February 2008 can be read here:
Adobe Reader PDF


E-learning program for in vitro methods

The scientific coordinator of the FP6 project ACuteTox, Expertrådet, is producing an e-learning program for the testing strategy and the methods that will be the result of the project. To get a good implementation and a wide use of the in vitro methods it is important to make it convenient for the industry to use them. One way is to produce interactive manuals that make it possible to attain reproducible results with high and equal quality in all laboratories.

Expertrådet has developed a pedagogic model for an interactive manual within the ACuteTox project. The SOP text is supplemented with short video sequences, photos and drawings that clarifies critical phases of the test methods. Each test will be presented in three different levels: 1) an introduction level where the tests are presented briefly to demonstrate the opportunities of the test; 2) a second level with the SOPs of the tests and with video sequences or pictures that demonstrate how to carry through the tests; 3) in the third level the scientific documentation and background of the tests could be find. The second level is the main part of the e-learning program that will consist of the interactive manual.

This model could also be useful for the other FP6 projects within the in vitro area and it would certainly be convenient for the endusers if the e-learning programs from the different projects looked similar and had the same pedagogic model. Expertrådet is willing to assist other in vitro projects to produce similar e-learning programs.

Contact for more information:,

Adobe Reader PDF

Consortium meeting held on February, 20-22, 2008 in Konstanz

After the consortium meeting held in February 2008 in Konstanz, the phase of data compilation and generation has been completed. At this meeting, new software (Acusoft) was presented which will facilitate the estimation and comparison of IC50 values from atypical dose-response curves obtained in different test systems and with different compounds. Furthermore the incorporation of chemical properties of a given compound (pH, lipophilicity, protein binding) was shown to be a good indicator of their kinetic behaviour and to be a very efficient corrector factor for the correlation between in vivo and in vitro data.
A new committee within the project was established from members of the advisory board and from ECVAM. Their task is to develop a test strategy, using the best performing assays in the testing of the 57 reference chemicals. This pre-validation phase will start in the second half 2008.
Sens-it-iv top
II.1.4. Sens-it-iv

Sens-it-iv is an Integrated Project financially supported by a grant from the European Commission (LSHB-CT-2005-018681). 28 groups overall, of which 9 represent industry. 15 groups represent universities or research institutes, while 4 groups represent organizations.

II.1.4.1. Recent News

ecopa is part of work package 9 and is responsible for “Technology transfer and Dissemination”. Technology transfer and dissemination of project results, including knowledge, will be a key activity throughout the term of the Sens-it-iv project.

ecopa has taken over the responsibility "spreading the news/results" of this EU project, and released a brochure covering the activities on behalf of Sens-it-iv, and supported the website creation. The folder and poster can be downloaded on the website, section press material. Technology transfer and dissemination of project results, including knowledge, will be a key activity throughout the term of the Sens-it-iv project.

The first Sens-it-iv Newsletter appeared on December 14, 2006 and now the 21st edition is available via the website or the link below. ecopa is part of work package 9 and is responsible for “Technology transfer and Dissemination”. The newsletter is coordinated by the WP9 leader.

Newsletter Nr. 23 is out:

Newsletter-subscription possibility on the website.

The yearly organised General Assembly has taken place on October 21-23, 2008, in Maribo, Denmark.

Adobe PDF PDF: Sens-it-iv - First publishable summary (114 kb)
Adobe PDF PDF: Sens-it-iv - Publishable executive summary - 2nd year (80 kb)
BioSim top
II.1.5. BioSim

BioSim, or "Biosimulation A New Tool in Drug Development" started December 1, 2004. BioSim is a Network of Excellence supported by the European Commission as part of its 6th Framework Programme.

II.1.5.1. Recent News

Report by Flavia Zucco, BioSim Advisory Scientific Board:

The 4th BioSim Conference was held in Budapest from September 24 to 27, 2008. The advancements of this NoE are impressive and strong networking collaborations have been by now established. It is worthwhile to mention the books published, which make this network the leader in Europe in opening the way to integrated research in the interdisciplinary area of biological system simulations.

Martin Bertau, Erik Mosekilde and Hans Westerhoff have edited a book for Wiley-VCH on ‘Biosimulation in Drug Development’ with contributions from a significant number of BioSim-partners. With its 512 pages and 18 chapters, the book provides what can be considered the first comprehensive presentation of some of the most important aspects of modeling and simulation in drug development and health care.

Fred Boogerd, Frank Bruggeman, Jan-Hendrik Hofmeyr, and Hans Westerhoff (partner 3) have published a book entitled: ‘Systems Biology: Philosophical Foundations’ that touches on the problem of whether Biology is entitled to its own scientific foundation rather than being subjected to existing frameworks.

Olga Sosnovtseva and Erik Mosekilde (partner 1) have edited a special issue of Journal of Biological Physics on ‘Biosimulation’ with a significant number of BioSim-contributions, and Morten Brøns (also partner 1) is co-editor of a special issue of the American Physical Society Journal Chaos on ‘Multi-mode Dynamics’.

One of the most important aspects of that project is that it has been trying to cover the wide approach to the different levels of complexity of the living organism: it has always tried to couple the micro to the macro levels, from the molecular to the physiological and clinical ones. However the main problem is now how to go on, since it is goes to the end by November 2009 and no NoE calls are available in the 7FP. The hope is that the partners which have been the core of BioSim will be able to sort out an IP of about 15 participants, taking on the most promising lines of research produced by BioSim. The next final Conference is scheduled for the end of August 2009 in Copenhagen, the town of the Coordinator Prof Erik Mosekilde.

ecopa Liintop top
II.1.6. Liintop

II.1.6.1. Recent News

Structure of the project, information on partner and new on events can be taken from the website:
CarcinoGENOMICS carcinoGENOMICS top
II.1.7. carcinoGENOMICS

carcinoGENOMICS is an Integrated FP6 Project financially supported by the European Commission (LSHB-CT-2006-037712).19 groups are present  of which 6 represent industry, 11 represent universities or research institutes, while 2 groups represent organizations.

II.1.7.1. Recent News

Adobe PDF PDF: CarcinoGENOMICS Press Release (24 kb)

The last carcinoGENOMICS-Project Board was held on September 15/16, 2008 in Brussels, Belgium. This year’s carcinoGENOMICS Annual Meeting was held on November 10-12, 2008 near Dublin, Ireland.
ecopa II. 2. EU 7th Framework Programme Projects, Initiatives and Technology Platforms top
SusChem SusChem top
II.2.1. Sustainable Chemistry (SusChem)

The Technology Platform SusChem has been formed and finalized its Implementation Action Plan. The action plan can be downloaded from the SusChem website.

The tenth SusChem newsletter is now online:

A detailed review of the SusChem platform activities can be found in a supplement of the September 22 issue of the ICIS Chemical Business.

II.2.2. Regulations of the 7th Framework Programme
Update 7th EU RTD- Framework Programme

Though intended as part of the EU-competitive efforts in Research and Development, the EU still is behind its own targets laid down in the Lisbon Strategy. According to the EU statistics officer, the 27 EU states invested in 2006 as much (or little) as in the year before, i.e. 210 billion EURO equivalent to 1.84% of its economical output. Lisbon asks for 3% in 2010.

Guidance on FP7 implementation

A number of guidance documents and preparatory work are carried out by the European Commission in view to install the basis of the FP7 implementation. The following documents are available for consultation on where they can also be downloaded:
• a standard Model Grant Agreement,
• a draft Guide for Beneficiaries,
• a draft Guide to Financial Issues,
• a draft Guide to IPR and
• a draft Checklist for the Consortium Agreement.

ecopa is interested to participate with partners in some of the calls dealing with alternative methods and being announced in the future, esp within the HEALTH resp. the ENVIRONMENT sectors of the 7th FRP.

ecopa submitted a proposal for a Support Action in the HEALTH-2007-1.3-2 call: Bottlenecks in reduction, refinement and replacement of animal testing in pharmaceutical discovery and development. The proposal is called “Scientific and technological issues in 3Rs alternatives research in the process of drug development and Union politics” with the acronym: START-UP. Several NCPs are collaborating in this project. The project was approved “Grant Agreement” No. 201187 and signed on March, 12, 2008.

II.2.3.1. The Abstract of the proposal

The START-UP project is concerned with the identification and proposals to abolish bottlenecks in the 3Rs approach in pharmaceutical discovery and development. The goal of the project is the organisation of 3 Workshops in order to determine a) the state of the art of each of the 3Rs in the EU, b) to assess European strength and gaps in 3Rs and c) the identification of rate limiting steps on the political, scientific, technological level. As a result, a Consensus Paper containing the concepts and suggestions for a Roadmap for future research will be produced.

Stakeholders (among them European Pharmaceutical Industries (EPI)) have identified bottlenecks in drug development and in the integration of in vitro methods Early identification of wrong candidates for further development and avoiding efforts for under-performing candidates, are essential for the competitiveness of European Industry. Identification of bottlenecks in the implementation of reduction, refinement and replacement of animal experimentation in drug R&D, should assist in identifying the best in vitro and in vivo systems, and to speed up the drug development process. Existing hurdles in the scientific, technological, political and environmental level (including regulatory), play a substantial role and are rate-limiting in developing new drugs, including biological entities (almost 50% of the currently developed products).

ecopa (the quadripartite umbrella NGO for alternatives) structures with its VUB partner this support action around 3 major workshops which will be preceded by 3 Expert Meetings redefining and prioritising current bottlenecks in 3Rs methodology; with EPI, drug discovery and development. Each phase has its own specific needs, and analysing the present limitations and gaps needs to be addressed, e.g., many cell systems do not yet have the required stability for genomics, proteomics or metabonomics analysis; many current in vitro cell systems lack crucial bioactivation capability. Consequently, the status of satisfactory “predictive” pharmacology and toxicology in vitro has not yet been reached.

In terms of politics and ethical concerns, considerable differences in regard to the use and development of transgenic animals, human tissues and stem cells create an atmosphere of insecurity for an effective academia and industry cooperation.

The final goal of this action is a Consensus Document that analyses present status.

Details of the project were presented by the Chair of ecopa on the occasion of the 11th Linz Alternative Congress, September 28-30, 2007.
Adobe PDF PDF: Presentation by Prof. Vera Rogiers (1,2 MB)

NEWS: The first START-UP expert meeting has taken place in Madrid, Spain, on June 19, 2008. On June 20, 2008, there was following a public meeting, organized by REMA together with ecopa. The second expert meeting has taken place in Basle, Switzerland, on the Novartis Campus, with participation of industry representatives on September 5, 2008. The third expert meeting was organized together with the eSI workshop. This has taken place in Pueblo Acantilado, Alicante, Spain from October 16 to 19, 2008.

The first major workshop of the START-UP project , on Refinement, will be held in Rome, Italy, at the L’Istituto Superiore di Sanità (ISS) on February 26-27, 2009, starting at 14:00 on Thursday and ending at 13:00 on the next day Friday. The second workshop, on Reduction, will be held on May 18-19, 2009. The third workshop, on Replacement, will be held on October 2-3, in Budapest, Hungary.

Project acronym: ESNATS
Project full title: Embryonic Stem cell-based Novel Alternative Testing Strategies
Grant agreement no.: FP7 - 201619.

The aim of the ESNATS project is to develop a novel “all-in-one” toxicity test platform based on embryonic stem cells (ESCs), in particular human ESCs, to accelerate drug development, reduce R&D costs and propose a powerful alternative to animal tests in the spirit of the “Three R principle”. ESNATS objectives will be achieved in a 5 year multi-disciplinary collaboration of leading European researchers in alternative testing, toxicology, ESC research, genomics, modelling, and automation. The consortium will also include representatives from regulatory bodies, the pharmaceutical industry and ethical advisors to provide guidance to ensure rapid applicability of the developed test systems.

ecopa has taken over some tasks in disseminating results of this project, developed the logo, and is leading the respective workpackage.

ESNATS Kick-Off meeting was held from April 21 to 23 in Cologone, Germany. Dr. Bernward Garthoff presented ecopa and the work which ecopa will do in the Workpackage 5 of ESNATS. The last Board meeting was held end of October in Dortmund.

The above ESNATS logo was brought in by ecopa.
ecopa Miscellaneous top

III.1. Events

III.1.1. ecopa events

III.1.1.1. 9th Annual ecopa Workshop

The 9th Annual ecopa Workshop has taken place on November 29-30, 2008 in Brussels, at the Sheraton Airport Hotel.
Website Presentations of the 9th Annual ecopa Workshop
The future ecopa Annual Meetings will be:
10th: November 28-29, 2009
11th: end of November 2010

III.1.1.2. ecopa Board meeting

Adobe PDF Minutes ecopa Board Meeting of September 25, 2008 (180 kb)

The next ecopa Board meetings (addressing also the START-UP project):
- February 25, 2009 in Rome, Italy
- October 1, 2009 in Budapest, Hungary
eSI eSI - ecopa Science Initiative top
III.1.1.3. eSI: ecopa Science initiative

The eSI-Conference under the general heading: "Reaching the young scientist" is an initiative organised by ecopa aimed at bringing together senior as well as young researchers to discuss about the new technologies and their applicability in ‘in vitro’ research as well as to improve creativity and innovation in the search for alternative methods. ecopa had performed a detailed literature analysis of the last 5 years of research in alternative methods and had concluded that this area of applied research is drying out.

The full report, presentations, and the final program are listed on the ecopa website in the archive section.

NEWS: The latest workshop has taken place in Pueblo Acantilado; Alicante, Spain on October 16-19, 2008, with the attendance of senior scientists and young researchers of 14 countries. It focussed on "Recent developments and potentially novel approaches of science to alternative testing of cosmetics and pharmaceuticals”. It was held together with the European Partnership for Alternative Approaches to Animal Testing, EPAA.

New aspects of pharmaceutical and cosmetic research are covered also in regard to the START-UP project. Sponsoring was provided by Badecos/Rogiers, Bayer, set and EPAA.

Website Presentations of the eSI Meeting
Website Photos of the eSI Meeting
III.1.2. other events

III.1.2.1. Mondial Research Group’s 4th Annual International Conference on "Predictive Human Toxicity and ADME/TOX Studies"
Predictive Human Toxicity and ADME/Tox Studies 2009 is scheduled for the January 22-23, 2009 in Brussels, Belgium. Two-day training course on ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development preceeding the conference. January 20-21, 2009.

For more information:

III.1.2.2. 1st Danish Workshop on Refinement, Reduction and Replacement (3Rs) of Animal Studies
The theme of the workshop is ‘Towards a common understanding of the meaning of the 3Rs’, the overall objective being to raise the awareness that alternatives to animal experimentation is not only replacement, but also refinement and reduction.
January 22-23, 2009 at Vilvorde Kursuscenter, Charlottenlund, Denmark.

For more information:
» TO%201st%20DANISH%20WORKSHOP%20-%20final-1.doc

III.1.2.3. Looking into the crystal ball: the laboratory animal in a changing world
A joint symposium of 25 years Division of Laboratory Animal Science, 15 years Netherlands Centre on Alternatives to Animal use, and 5 years Department of Animals, Science en Society (DWM in Utrecht!)
February 5-7, 2009 in Utrecht, The Netherlands.

For more information:

III.1.2.4. Stem Cells: Drug Discovery & Therapeutics
This conference addresses both therapeutic and non-therapeutic stem-cell applications. Experts in stem cell science and applications, as well as policy and bio-business come together to cover the emerging role of stem cells in drug development and therapy. As stem cell science matures, it becomes clear that supply and technology will soon cease to limit product development, and that pharmaceutical companies engaged with stem cells will have a competitive advantage.
February 16-17, 2009 in London, UK

For more information:

III.1.2.5. Fourth Annual Stem Cells Congress
Contributing to the Future of Regenerative Medicine February 25-27, 2009 at the Mascone North Convention Center, San Francisco, California, USA.

For more information:

III.1.2.6. 5th Anniversary Cambridge Healthtech Institute’s Quantitative PCR
PCR’s sensitivity, specifi city, and simplicity has revolutionized molecular biology in basic, industrial, and clinical settings. However, complexities arise because of multiple assays, numerous protocols, abundant sources, lack of assay standardization, differences in sample processing, ineffective use of controls, normalization methods, and quality control management. Researchers face challenges in reliability, relevance, and reproducibility. Learn from savvy, seasoned researchers as they share their real-world experiences, applications, and results.
March 16-17, 2009 at the Hilton San Diego Resort, San Diego, California

For more information:

III.1.2.7. The Forinvitox Forum event
The First Market place in Europe for inventions, applications and products for in vitro toxicology testing methods. This is a forum where inventors of in vitro methods have a chance to meet producers, end users and regulators.
May 12-14, 2009 in Stockholm.

For more information:

III.1.2.8. FIRST ANNOUNCEMENT for the 7th WORLD CONGRESS on Alternatives
August 30 to September 3, 2009 in Rome, Italy

For more information:
III.2. Awards and Publications

III.2.1. InterNICHE: 2008 Humane Education Award

Interniche announces the 2008 Humane Education Award to support ethical and effective life science education and training.

The Award is a grant program to enhance biological science, medical and veterinary medical education and training. Supported by Proefdiervrij, the Award offers 20,000 Euro (US$ 25,000) to be split between successful applicants.

Proposals are invited from all countries for initiatives to replace animal experiments and the dissection of purposely killed animals. Applicants may be teachers, students, campaigners or any other individuals committed to best practice education and training.

For more information see the website:

III.2.2. German ministry of nutrition, agriculture and consumer protection announces a call for its 28th research award

Deadline for submission March 31st, 2009. The award (of €15.000) is presented to researchers working in the field of alternatives. The work has to be presented in German or English, in 8 copies.
Submissions to Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz, Referat 321, Rochusstrasse 1, D – 53123 Bonn.

III.2.3. Booklet on Alternative Testing Strategies

The European Commission has published a booklet on all European FP6-projects concerned with alternative testing.

You can download it from this link:

III.2.4. CHI’s Insight Pharma Report

Systems Biology: A Disruptive Technology”: This report focuses on the current and future applications of Systems Biology in drug discovery, specifically in pinpointing optimal individual targets, and combinations of targets, to overcome metabolic pathway redundancies, leading to efficacious and safe products.

For more information:

III.2.5. Structure-Based Drug Design: Conference proceedings CD available

The conference proceedings of the CHI's Eighth Annual Structure-Based Drug Design conference, which took place in June in Boston, MA are available on CD. This CD features 25 speakers’ slides and papers. It is available for $250.

You can order it here:

For more information:

III.2.6. The European Medicines Agency (EMEA) has published a draft document for consultation

'EMEA/CHMP Working Group with Healthcare Professionals - Recommendations and Proposals for Action' (EMEA/185036/2008).

The document is available here:

III.2.7. The European Medicines Agency (EMEA) has published a concept paper on 'single dose/acute toxicity'

The document is available here:

III.2.8. NC3Rs Newsletter 18, December 2008

The 18th edition of the NC3Rs-newsletter (December 2008) is available now.
You can subscribe for this here:

III.2.9. New Book out regarding "Safety Assessment of Cosmetics in Europe"

For more information:

III.2.10. Launch of the new TSAR website to inform about the development of alternative methods

The European Commission has launched a new website, the so-called 'Tracking System for Alternative test methods Review Validation and Approval (TSAR)', designed to track the development of new alternative test methods which should replace, reduce and refine current animal testing.

The purpose of TSAR is to enable citizens and other interested parties to track progress of the review, validation and approval of alternative test methods, ensuring greater transparency of the process. The ultimate aim will be to cover each and every step of the validation route, from submission of a new method for pre-validation through to final adoption by its inclusion in EU legislation and/or related Guidance Documents. It will also explain the decisions that have been made at every step of the process. When the final decision on a proposed test method is negative, TSAR will clearly indicate the reasons why this decision has been taken. The website will be updated whenever a phase in the process is completed, ensuring the latest information is always available. However, to enable a rapid launch, the initial version covers only the part of regulatory approval of methods in the field of chemicals.

The website is managed by the Joint Research Centre's Institute for Health and Consumer Protection.

For more information:
For more information, see also: SPEECH/08/574

III.2.11. Article in Altex: Research Expenditure for 3R Alternatives

Title: A Review of National Public Funding Programmes in European Countries
Authors: Tonia Devolder, Kirsty Reid, Vera Rogiers, Simon Webb and David Wilkins

Summary: A survey of publicly funded research specifically targeting alternatives to animal testing was conducted over 2006/2007. Responses were received from 16 European countries (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland and the United Kingdom). The responses were compiled by national agencies or national consensus platforms. The current annual total across the 16 countries was estimated as € 17 million. The largest contribution came from Germany with € 4.6 million (27% of the total). Also collated was information on the existence of a national strategy on alternatives research, the focus of any such strategies, the research priority setting process, stakeholder consultation in that process, project funding preferences or limits, coordination mechanisms and the separation of responsibilities of competent authorities (i.e. for research support, laboratory animal welfare and chemicals management). Countries with national strategies (France, Germany, the Netherlands, Sweden, Switzerland and the UK) are skewed towards the higher end of the spending distribution. These 6 countries account for over € 12 million, i.e. >70% of the overall total of national spending identified. Most countries have national consensus platforms. These should help to both stimulate stakeholder consultation and further national spending on alternatives research. The situation regarding the separation of responsibilities of competent authorities (i.e. for research support, laboratory animal welfare and chemicals management) is mixed. A degree of overlap exists in many cases. A research strategy that is receptive to and reflects regulatory developments – such as REACh with its marked resultant increase in animal use – is an obvious need that is as yet unmet in many of the countries surveyed. The need for a mechanism to collate details of active research projects within Europe as a whole was also identified.

III.2.12. ECVAM website extension has been changed

The website address of the ECVAM and DB-ALM have been changed. As one may have noticed, the previous addresses and do not work anymore and one will not be redirected to the new addresses.

With immediate effect, please only refer to the following website address:
» for the ECVAM, and
» for the DB-ALM.

III.2.13. Animal welfare Directive revision proposal [COM(2008) 543/5]

The first stage in the production of the new directive on animal experimentation has finished. After many years of deliberations, consultations and internal delays, the European Commission has adopted a draft wording and published it as a formal proposal for a new directive.

This proposal has been sent to both the European Parliament (composed of the MEPs) and the European Council (composed of representatives from the Member States). Both these bodies will give it a first reading, making proposals for changes to each other and then, taking each others proposals and the Commission's reaction into account, they each have a second reading. All three bodies - Commission, Council and Parliament - have to reach agreement on the text. If they cannot do so after the two readings, there is a Conciliation Committee formed with representatives from all three bodies, which has a deadline to hammer out a compromise.

The full text can be found at:

III.2.14. Stem cells online journal

For more information:
III.3. Calls and Vacancies

III.3.1. The ECLAM ESLAV Foundation is now accepting applications for funding in 2008-2009

It is a charitable organization that funds studies for the discovery, validation and implementation of refinement of the care and use of animals in research. In particular the Foundation funds small studies, up to 20'000 Euro in the following areas:

- Refinement in experimental techniques, anaesthesia and analgesia to reduce pain and distress
- Objective measures of animal welfare.
- Studies to ensure scientific basis for housing and husbandry standards
- Validation of environmental enrichment to improve behavioral well being

Funding applications for 2007-2008 are closed. 2008-2009 applications are open (since early 2008) for information only an application form, including guidelines for applicants and information how to submit an application, can be downloaded here: 2008 form.

The Foundation's website can be found at:
with a grant application form at:
A leaflet describing the Foundation is available at:

III.3.2. Call for expression of interest as Members of the Board of Appeal of ECHA

The European Commission has published a call for expression of interest in the appointment as chairman and as members of the Board of Appeal of the European Chemicals Agency. For further information see the attached notice and the addresses (links) mentioned in the notice.


III.3.3. Call for interest for Grantholders for Doctoral and Post-doctoral positions in ECVAM

The Institute for Health and Consumer Protection (IHCP) has launched a call for interest for Grantholders for Doctoral, Post-doctoral and Senior Research Positions. ECVAM, part of the IHCP, offers two of the Grantholders positions.

For more information:

III.3.4. Two new Marie Curie Calls open

Two new Marie Curie calls have recently been published:
COFUND: Cofunding for fellowships (40%); deadline February 19 2009.

A complete overview of relevant calls can be found at:

III.3.5. Third FP7-HEALTH call

The publication of the third call for the FP7-HEALTH program, with an indicated budget of 590 million euro, has been postponed. The call has been published in September, with the deadline of submitting before December 3, 2008.

The actual text for the most interesting part of a support and coordinating action, is given below. Ecopa is interested to support parties building consortia in response to this call. Please contact our secretariat to learn more about it.

Topic for 3rd call, single-stage submission and evaluation; deadline 3 December 2008: - HEALTH-2009-1.3-1: New initiatives towards the implementation of the Replace, Reduce and Refine strategy. FP7-HEALTH-2009-single-stage. The development of new ‘3R’-methods as modern alternative approaches to safety testing requires a better co-ordination of the various activities involved. This should start with the mapping of existing research results, followed by the development of new ideas for alternative approaches and strategies, and promotion of communication, education, validation and acceptance of alternative approaches. The funding scheme would be a support and co-ordination action aimed at bringing academic research in a pro-active way closer to the industrial landscape in order to effectively develop concrete collaboration projects with industrial partners. This coordination action should build particularly on the success of activities carried out in the EU RTD Framework Programmes and in national activities. Funding scheme: Coordination and Support Action (Coordinating Action).

The following specific CORDIS address leads you to the work programme of HEALTH (via "Information package"): call_id=140&act_code=HEALTH&ID_ACTIVITY=1

The maximum EU contribution to Coordinating Actions is 1.5 million EURO. Duration: 3 - 5 years.


It is to be expected that there will be two parallel calls with 2 deadlines.

One in which the single-stage hand over/evaluation will be applied (for most of the topics)
FP7 Health-2009-single-stage (call A)
for small-scale collaborative projects
indicative budget: 476 Million €;
deadline: November 20, 2008.
For this first call most topics are closed by now.

A second one in which two-stage hand over/evaluation will take place (only for some topics)
FP-Health-2009-two-stage (call B)
indicative budget: 115 Million €.
deadline stage 1 of call B: October 21, 2008
deadline stage 2 of call B: February 19, 2009


III.3.6. ECVAM Open Call for Tender

The Institute for Health and Consumer Protection (IHCP) had launched an open call for tenders to update the information content of the ECVAM DataBase service on ALternative Methods to animal experimentation (DB-ALM) in the area of non-animal techniques for the study of percutaneous absorption of chemicals and/or formulations.

Access to the official notice:
• Document no: 2008/S 63-084364 available from the Tenders Electronic Daily Homepage
• See also on the ECVAM Website in the section News Events and Meetings

Deadline for submitting offers was 4th November 2008.

Contact Address:
Further information including the relevant tender documents can be obtained from Tel: +39-0332-789197; Fax: +39-0332-789434

III.3.7 Erasmus Mundus grant to teach on the EUROPUBHEALTH Masters Course

Europubhealth is a two-year fully integrated European Masters Course coordinated by EHESP French School of Public Health and supported by the Erasmus Mundus programme. It includes five other partners: University of Rennes 1 (France), University of Copenhagen (Denmark), Andalusian School of Public Health (Spain), University of Sheffield (United Kingdom) and and Jagiellonian University of Cracow (Poland).

The Erasmus Mundus programme offers grants to third countries scholars (teachers) who are interested in carrying out research, teaching assignments and scholarly work for 3 months linked to the Europubhealth Masters Course.

For more Information:

III.4.1 Public Consultation on the Green Paper 'European Research Area: New Perspectives'

The European Commission invites citizens and stakeholders to participate in the debate on the European Research Area (ERA), in particular by putting forward their views in this public consultation. The consultation is based on the questions raised in the Green Paper 'The European Research Area: New Perspectives'.
The results of the debate will be used by the Commission to prepare initiatives that will be proposed in 2008.
More detailed information can be found on:

For more information and to participate in the consultation please visit the consultation web site.

III.4.2. The NC3Rs - Information Portal - Species selection

The British NC3Rs has an extensive Information Portal where to find a wide range of references and links for guidance on implementing the 3Rs.
A new section on species selection has recently been added. Where animal use is necessary in research or testing, the choice of species (and breed/strain) should always be carefully considered and justified. This page sets out some of the factors to consider, particularly in relation to the 3Rs.

III.4.3. NC3Rs announces new Board Chair as Professor Ian Kimber

Professor Ian Kimber, University of Manchester, has been appointed as the new Chair of the Board of the NC3Rs.
Professor Kimber will lead the Board, which oversees policy and strategy and is consulted on major spending decisions, from 3 July 2008 for a three year term. He replaces Lord Turnberg of Cheadle, who led the Board from May 2004 till October 2007.

For more information:

III.4.4. The DB-ALM has published a new data sector

In addition to the new information on methods recently published, the DataBase on ALternative Methods (DB-ALM) of the Institute for Health and Consumer Protection (IHCP) to which ECVAM belongs to has also made available for public access the directory on contact details of: “Persons & Institutions active in the Field of Alternative Methods."

For more information:

III.4.5. CARDAM: Centre for Advanced Research & Development of Alternative Methods

CARDAM is a newly formed institute for research and development of alternative methods.

For more information:

III.4.6. VirtualToxLab is available on the internet

In the past year, VirtualToxLab™ — an in silico tool for predicting the toxic (endocrine-disrupting) potential of drugs, chemicals, and natural products — has been thoroughly tested and is now available for all interested parties: universities, environmental NPOs, governmental agencies, regulatory bodies, hospitals and particularly for the chemical, pharmaceutical, cosmetics, food and biotech industry. The fully automated protocol estimates the binding affinity for any molecule of interest towards a series of 12 proteins, known or suspected to trigger adverse effects by simulating and quantifying their interactions with the human protein using automated, flexible docking combined with multi-dimensional QSAR. The VirtualToxLab™ is accessible over the Internet from any computer hardware and operating system. The VirtualToxLab™ allows to rationalize a prediction at the molecular level by analyzing ligand binding at all protein targets in real-time 3D. Details are given in the Winter 2008/9 newsletter.

Full details are given in the 2008 Newsletter which is available for download at:

III.4.7. Press Release from Utrecht University: ‘Cell culture and computer model can replace animal testing’

The health risks for people who are exposed to toxic substances are now mainly based on data from animal testing. Thanks to the advancement of biological expertise combined with the use of computer models, those risks can be assessed more and more accurately without having to use animals as a model for humans. These new strategies, which lead to the use of fewer test animals, should much stronger be encouraged by the government, Bas Blaauboer argued in his inaugural lecture on 4 November at Utrecht University. Blaauboer is professor of the Toxicology Division of the Institute for Risk Assessment Sciences (IRAS).

For more information:

III.4.8. The German Federal Institute for Risk Assessment (BfR) has job opportunities

The Federal Institute for Risk Assessment (BfR) is the scientific body of the Federal Republic of Germany that prepares expert reports and opinions on issues related to food safety and consumer health protection.

For more information:

III.4.9. Framework for International Cooperation on Alternative Test Methods (ICATM) adopted by ECVAM

A framework has been adopted to increase international cooperation, collaboration and communication on alternative test methods.
The International Cooperation on Cosmetics Regulation (ICCR) invited the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)- National Toxicology Program Interagency Center for the Evaluation of Alternative Methods (NICEATM), the European Centre for the Validation of Alternative Methods (ECVAM), the Japanese Centre for the Validation of Alternative Methods (JaCVAM) and a knowledgeable representative of the Government of Canada to address the issue of recognizing the importance of replacing, reducing, and refining animal testing and to propose options to ensure a collaborative approach in September 2007.

For more information:

III.4.10. The German Cancer Research Center (DKFZ) has job opportunities

The German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) is the largest biomedical research institute in Germany and is a member of the Helmholtz Association of National Research Centers.

For more information:

III.4.11. ECVAM has endorsed two in-vitro skin irritation tests

The ECVAM Scientific Advisory Committee (ESAC) has endorsed the scientific validity of two further in-vitro skin irritation tests on its 29th meeting held in November 2008. Both models (SkinEthic RHE and EpiDerm SIT) are based on reconstructed human epiderms and measure or predict the same biological or toxic effect as the fully validated and accepted reference method.

For more information: