8th Annual Conference of the European Biosafety Association, 2005

WELCOME BY EBSA PRESIDENT HELMUT BACHMAYER

SESSION 1

Rapidly developing and changing technology - a challenge for regulators
Paul Logan - Biological Agents Corporate Topic Group, Health and Safety
Executive, UK

Getting genetics under control: what is needed for genetics to work in the
public interest.
Sue Mayer - Genewatch UK

SESSION 2

Deliberate release of GM plants: two decades of biosafety experience.
Patrick Rüdelsheim - Perseus bvba, Belgium

Production of biopharmaceuticals in plants: state of the art, expected
benefits and potential risks.
Yuri Gleba - Icon Genetics AG, Germany

Problems of transgenesis and cloning biosafety
Louis-Marie Houdebine, INRA, France

FOYER /
UTRILLO

SESSION 4

Concurrent break-out sessions

Discussion Group 1:
Behavioral Based Safety
Moderator: Tim Marsh - Ryder Marsh (Safety) Limited, Manchester, UK

Around 90% of accidents have a "human" element and, consequently, huge efforts
have focused on changing operators' attitudes and motivation levels with limited
success. Behavioral programs have proved far more successful. Strengths and
weaknesses will be illustrated with examples and case studies. The workshop will
be highly interactive. It will focus on the techniques involved in developing measures
and observation checklists and the techniques of behavioral interaction and analysis.
The session will conclude with a thorough and interactive walk through of the
methodological options open to companies thinking of introducing or upgrading a
behavioral approach.

Disputes on Biotechnology usually end in sterile exchange of well known arguments.
There is no listening, no willingness to learn from each other. In order to change this,
we should follow certain rules, as for instance the 'symmetry of ignorance'
(or the asymmetry of knowledge). This means that different kinds of knowledge
should be respected, a difficult task well beyond naďve stakeholder concepts.
Linear planning and decision making should be replaced by management systems
of the second generation, which follow the rules of the 'Systems Approach' of
Churchmann and Rittel. Only if we realize that the difficult problems around the
new biotechnology are in fact 'Wicked Problems' which comprise also social and
cultural aspects, we will make some progress.

Discussion Group 3:
Medical Surveillance
Moderator: Gary Fujimoto, Palo Alto Medical Foundation, Palo Alto, California, USA.

The session will focus on issues related to medical monitoring and surveillance
for biological/biomedical laboratory staff. Case studies will be presented to
stimulate thought and discussion regarding a range of topics. These will
include such issues as infectious agents monitoring, viral vectors, oncogenes,
non-human primate exposures, vaccinations and other topics encountered in
these environments.
It will also emphasize the importance of close cooperation between biosafety
officers and medical professionals in anticipating emergencies requiring prompt,
appropriate intervention.

SESSION 7

Safe or unsafe? Almost two decades of EC risk assessment on GMOs
Ioannis Economidis - European Commission, Directorate-General for
Research, Strategy and Policy unit, Directorate for Biotechnology, Agriculture
and Food, Brussels, Belgium

The increased effort to understand the pathogenesis and host response of emerging
infectious disease and potential bio-terrorist threats along with the drive to develop
diagnostics, vaccines and therapeutics for these agents is leading to an increased use
of laboratory animals in containment. The integration of multiple species with multiple
agents in a facility, the introduction of advanced diagnostic technologies such as MR, CT
and PET, and the increased size of containment facilities to respond is creating new
challenges to the safe management of work involving research animals in these
facilities.
This presentation will identify how these challenges impacted containment facility
design for the facilities at various levels of biocontainment drawing on the recent
experience of CDC and NIH.

The Chris Collins Lecture

Chair: Helmut Bachmayer, Novartis Int. AG, Vienna, Austria

Biological Safety Concepts of Genetically Modified Live Vaccines
Joachim Frey - University of Bern Institute for Veterinary Bacteriology,
Bern, Switzerland