1. International Practical Trainings onInternational Practical Trainings on
Alternative Test MethodsAlternative Test Methods
Chantra Eskes1; Erin Hill2
1Services & Consultation on Alternative Methods, Agno, Switzerland; 2Institute for In Vitro Sciences, Gaithersburg, MD, USA
the limited number of places linked to the practical nature of the
workshop and in order to reach a wider range of audience, additional
workshops, within other Brazilian locations, are also foreseen pending
availability of sufficient support.
Scientific Program
The workshop will be spread over 3 days on November 16-18, 2011. It
will be a combination of lectures from national and international
speakers, and laboratory demonstration by IIVS personnel. The practical
training provided by IIVS will focus on: assays that are currently
accepted at the OECD level, the technical steps of adopted in vitro
protocols highlighting the critical elements of the protocol, the use of
good laboratory practices, and the interpretation of results for
regulatory purposes. Demonstrations will focus on the main steps of the
assays and several opportunities for hands-on participation by
attendees will be provided. An overview of the scientific program is
given below and more information can be found at www.iivs.org and at
www.farmacia.ufg.br/mestrado.
Organizing Committee
The workshop is being organized by SeCAM, IIVS, University of Goiás and a
local organizing committee comprised of representatives from
government, regulatory agencies, academia, industry and scientific
associations as described below.
International Needs
With the recent advancements and adoption of alternative methods to
animal testing , and the global harmonization of the world commerce, the
importance of providing education, throughout the world, on alternative
methods with regulatory standing is becoming increasingly necessary. In
particular, 1) the specifics of the in vitro test method protocols, 2) the
reliability and relevance of the method for regulatory purposes, 3) the
importance of ensuring good laboratory practices,
and 4) the necessity for a laboratory to
demonstrate proficiency, calls for education
preferentially based on practical demonstrations
and/or hands-on-training.
Such training is essential to scientists performing in
vitro tests, and is also key for regulators to make critical assessments of
the in vitro data applied to their specific needs. Furthermore, such training
could favor standardization of regulatory assessment and decisions on
hazard properties of chemicals across the world. A critical step is the
examination and interpretation of the resulting data for regulatory
purposes. It is expected that when familiarized to the biological basis and
relevance of alternative methods and the way in which the resulting data
can be interpreted and utilized, the more acceptance will these methods
Chantra Eskes SeCAM, Switzerland
Erin Hill IIVS, USA
Hans Raabe IIVS, USA
Marize Bozinis Federal University of Goiás, Brazil
Marcelo Vieira Federal University of Goiás, Brazil
Pedro Canisio Binsfeld Ministry of Health, Brazil
Josineire Melo Costa Sallum ANVISA, Brazil
Simone Fanan Hengeltraub Tridskin, Brazil
Vanessa Sá-Rocha Natura, Brazil
Jadir Nunes ABC, Brazil
Philippe Masson EVIC International, France
Eliana Lima Federal University of Goiás, Brazil
Dermeval de Carvalho BIOTOX, Brazil
Octavio Presgrave INCQS, Fiocruz, Brazil
Maria José Soares Mendes Giannini UNESP, Brazil
Such an inclusive composition allows for transparent and open discussions
on the aims and goals of the workshop, ensures considering the current
needs of the Brazilian scientific community and promotes broad
participation.
Sponsors Goiás Workshop
Official support Goiás Workshop
Opportunities for sponsoring and official support are still open !
References
Anonymous (2008). Law n.º 11.794, November 08, 2008.
Eskes C, Sa-Rocha V.M., Nunes J., Presgrave O., Carvalho D., Masson P., Rivera E., Coecke S., Kreysa J., Hartung T. (2009). Proposal for a Brazilian Centre on Alternative Test Methods. ALTEX 26, 265-268.
Marques RG, Morales MM, Petroianu A (2009). Brazilian law for scientific use of animals. Acta Cir Bras 2009, 24: 69-74.
Presgrave O, Eskes C, Presgrave R, Alves E, Freitas JC, Caldeira C, Gimenes I, Silva R, Nogueira S, Nunes J, Rivera E, Sá-Rocha V, Coecke S, Hartung T (2010) A proposal to establish a Brazilian center for validation of
alternative methods (BraCVAM). ALTEX 27, 47-51
can be interpreted and utilized, the more acceptance will these methods
gain.
Practical Workshop in Brazil
alternative methods (Eskes et al., 2010; Presgrave et al., 2010), and finally
several companies have been established that promote the use of in vitro
testing. However, information on the current international state-of-the art
is not always easily accessible to Brazilian scientists.
Due to these reasons many Brazilian scientists have expressed their
willingness to learn more about the regulatory use of in vitro assays and
have been extremely encouraging about initiating a series of in vitro
workshops. In response, IIVS and SeCAM joined forces to plan such a
series of practical workshops with the help of a local organizing
committee. The aim is to provide scientists with a theoretical and practical
understanding of the application, laboratory procedures and data
interpretation of in vitro methods.
The first workshop will be held at the Federal University of Goiás and has
regulators as main target audience, although it is also open to industry
and academia to promote harmonization across sectors. The University of
Goiás was chosen as an optimal location due to its geographical proximity
to Brasilia where many Brazilian regulators are located. However, due to
Maria José Soares Mendes Giannini UNESP, Brazil
Ana Marisa Fusco Almeida UNESP, BrazilIntroductory lectures and current status
• International acceptance and uses of alternative methods
• Brazilian regulatory needs and applications of alternative
methods
• The uses of alternative methods in Brazil: point of view of
the cosmetics sector, regulators, testing facilities and
academia
Practical demonstrations of in vitro methods
• Eye irritation: OECD TG 437 on BCOP
• Phototoxicity: OECD TG 432 on 3T3-NRU
• Skin Corrosion: OECD TG 435 on membrane barrier test
• Starting doses for acute toxicity: OECD GD 129 on 3T3-NRU
Additional lectures
• Human skin models for skin irritation & corrosion:
OECD TG 439 & 430
• GLP principles
• Interpretation of results for regulatory purposes
A certificate of participation will be provided by IIVS and the University
of Goiás.
In the recent years, Brazil has shown
increasingly interest in the applicability and
uses of alternative methods to animal testing.
In 2008, a new legislation was adopted that
regulates the use of animals for scientific
purposes, and requires the monitoring of
implementation of alternative methods (Law
n. 11.794, 2008; Marques et al., 2009). Since
then different proposals have been made for
the creation of centers dedicated to
Brasilia