Timetable:  19 July 2010

CEC-1. Individual susceptibility and biomarkers in occupational toxicology 
Chair persons: Fernando Gil; Antonio F. Hernandez (Univ Granada)
The venue will be Palalacio de congresos de Barcelona

Partly sponsored by Sanofi Pasteur and GSK Biologicals
Co-Chairpersons:   Lawrence Segal (GSK Biologicals, Wavre, Belgium), Sarah Gould (Sanofi Pasteur, Marcy L’Etoile, France)

Abstract

Vaccines are considered one of the safest and most effective medicines today, and are a growing area of interest and development activity in the pharmaceutical industry.  Vaccines, which initially were crude preparations, such as vaccinia vaccine now comprise a diverse range of products, including recombinant proteins, live attenuated products, toxoids, and vector based DNA vaccines.  Indication for these products include  prevention of infectious diseases as well as therapeutic benefit against disorders such as cancer and HIV.  In addition, modern vaccine formulations may be complex and contain novel adjuvants, excipients, multivalent antigens and be delivered by novel routes and/or delivery systems.
The safety evaluation of vaccines is vital, particularly for preventative vaccines, which are often given to healthy children and adults, placing special emphasis on their safety. The diversity of modern vaccine products requires that the safety evaluation must be specifically tailored to the investigational vaccine product under study.
This course aims to address the key issues regarding the nonclinical safety assessment required for vaccines, and will provide a clear overview of the current global regulatory guidelines, plus present an overview of the toxicological studies required to support both first time in man studies and further clinical development and/or licensing.  The course will provide an overview of study design and species selection for local tolerance, single and repeated dose toxicity, safety pharmacology, biodistribution and integration studies, as well as, fertility, reproductive and developmental toxicity bioassays. In addition, the course will also consider other factors specifically related to the hazard assessment of vaccines, including hypersensitivity and autoimmunity and environmental safety assessment.  In addition, the requirements for safety assessment regarding the presence of residuals, contaminants, leachables and extractables will also be considered.
The course would be of interest to a wide audience including students, clinicians, consultants, regulators as well as anyone currently employed in the pharmaceutical field with limited familiarity of vaccines. It would provide an introduction into the safety consideration of vaccines from a toxicology perspective.

Course presentation:
This continuous education course is presented as an overview to the ECVAM scientifically validated methods for the reproductive and developmental toxicity. This course will provide a practical approach to the Embryonic Stem Cell Test (EST), the Micromass test (MM), to the Whole Rat Embryo Culture (WEC) and also to the Fish Embryo Test (FET) with zebrafish. Expert speakers will introduce the session with the following topics: teratology evaluation in vivo versus in vitro, regulatory aspects of teratology evaluation, advantages and disadvantages of the tests and last advances in the field. Practical cases will be discussed by the GRET-CERETOX laboratory staff that is usually working with these techniques.

Course localization:
School of Pharmacy, University of Barcelona (Building B, Classroom B-205).
Av. Joan XXIII s/n. Barcelona. 08028

Course contents:
Teratogeny and embryotoxicity: state of the art. Miquel Borràs.
Teratogeny preliminary evaluation. In vitro screening tests. Burkhard Flick*.
Practical session I: Whole Embryo Culture and Fish Embryo Test with Zebrafish. Elisabet Teixidó, Núria Boix, Burkhard Flick and Marta Barenys.
Practical session II: Micromass test and Embryonic Stem Cell Test.Lydia Camps David Ramos, Javier González-Linares and Joaquín de Lapuente.

*DR. Burkhard Flik is an expert in Reproductive Toxicologyin vivo and in vitro. In the near past, he was Lecturer in Berlin University and now is the Head of Laboratory Reproductive Toxicology at BASF (Germany).

CEC-4. Evaluation of drugs without animals 
With the collaboration of REMA (The Spanish Network of Alternative Methods)
The venue will be school of Pharmacy, University of Barcelona (Building B)

Chairs:
Domingo Gargallo (Ferrer International. Toxicology and Safety Pharmacology Barcelona)
Joan Albert Vericat (Noscira. Madrid. Spain)

Objective: Toxicology Information Online: A Practical Course on Web-based Resources
Instructors:
Guillermo Repetto, National Institute of Toxicology and Forensic Sciences, Sevilla, Spain
Philip Wexler, Toxicology and Environmental Health Information Program, National Library of Medicine, USA

The informatics infrastructure of toxicology grows increasingly vast and complex, with new resources and tools appearing on the Web on a regular basis, and with collaborative networking and mobile tools multiplying rapidly.  This practical course, including online demonstrations, attempts to impose some structure on the cornucopia of Web based toxicology resources.  Participants will first be offered an overview of resources from the US National Library of Medicine's Toxicology and Environmental Health Information Program, the home to such classic databases as TOXLINE and the Hazardous Substances Data Bank.  Another segment of the course will focus on databases and resources from elsewhere, internationally. Finally, the course will conclude with a look at consolidating type Web tools, which offer access to information from a variety of sources.  Examples are the EU's ECHA and ESIS resources, Spain's BuscaTox and the OECD's eChemPortal.  In between these lectures, there will be ample opportunity for participants to get hands-on training, utilizing the resources discussed by answering practice questions or otherwise exploring their potential.

Agenda:

This course will provide an overview of old and new approaches to neurotoxicity assessment. The course will provide the attendants a basic knowledge of a broad variety of the basic and advanced methods available for neurotoxicity assessment, including presentations for understanding the potential utility of each of the different methods. Five lecturers will present on a wide variety of topics that include:  brain and sensory toxicity; in vivo and in vitro models; screening and non-screening purposes;  choice of animal species; histological, behavioral, physiological and molecular methods; high specificity and high-throughput screening