EBSA12 Preconference Courses 2009

A. Running a BSL2 environment in a safe way – a practical approach



T. Koivula, Swedish Institute for Infectious Disease Control, Stockholm/Sweden
Per Staugaard, Biosafety Training & Consultancy, Utrecht/NL

Short description:
This workshop will provide an introduction on managing practical biosafety issues in a BSL2 environment [lab, biotech production, animal facilities]. The course is particularly suitable for laboratory managers responsible for supervision and for safety standards and training [“qualifica-tion”] of personnel. Previous experience is not required.
This workshop will give the trainees an opportunity to perform practical, hands-on training in a BSL2 lab environment under the supervision of experienced trainers. The exercises will be based on different scenarios and include, for instance, a spillage exercise, testing and choosing of adequate personal protective equipment (PPE), and fit-testing of respirators. Practical sessi-ons will also include visualizing proper use of a biological safety cabinet (BSC) as well as ex-amining methods for decontaminating hands and work areas.
The participants will in addition be given tools to improve their recognition of “unsafe” situations in their work environments.

B. Biorisk assessment

Asa Szekely Bjorndal, Swedish Institute for Infectious Disease Control, Stockholm-Solna/Sweden
Otto Doblhoff-Dier, onepharm Research and Development GmbH, Vienna/Austria
Laszlo Szekeley, Karolinska Institutet, Stockholm-Solna, Sweden

Short description:
The workshop will start by introducing the principles and methods underlying risk assessment for activities involving hazardous biological materials. This will be followed by an interactive session involving participants, and then by a more focused consideration of risk assessment involving work with different biological agents including genetically modified micro-organisms (GMM) and with a variety of biological materials where there is known, suspect or possible contamination with infectious agents. Special considerations when working at different containment levels will also be covered. Biosafety and biosecurity aspects will be discussed. The second part of the programme will use a case study approach, where participants will work in smaller groups to develop and understand the process of risk assessment as it relates to biosafety. At the end of the workshop, participants will share their learning in a concluding plenary session.

C. A practical guide to transport, export and import of biological materials and GMOs

Kristel Vermeersch, KVS & Partners Dangerous Goods Consultants, Kampenhout/Belgium
Patrick Rüdelsheim, PERSEUS BVBA, Zwijnaarde/Belgium

Short description:
Import, export and transport requirements focusing mainly on the movement of biological materials between Europe and the US. This is a complex area which often touches several competent authorities. Although there will be some presentations by experienced people in the field, the learning experience will be centered on the discussion of your problems and questions. Bring them to the course and share them with others!

D. BSL3 containment principles and facility design

Philippe Stroot, Xibios Biosafety Consulting, Tournai/Belgium
Patrick De Graeve, IPS-Group, Nivelles/Belgium

Short description:
This full day course aims at providing biosafety professionals and facility managers with the theoretical and practical knowledge that should equip them to deal with BSL3 construction projects in an efficient way. The course has been designed for professionals who have at least a basic knowledge of biosafety regulations and some experience with BSL2 facilities.

It will consist of two parts, one on the containment principles that are used at BSL3, the other on the design and construction of a BSL3 facility. This second module will cover the organisa-tional and conceptual aspects as well as some very specific, practical issues to consider when dealing with a construction or renovation project. The choice of equipment as well as commis-sioning and validation will be discussed. This module will also deal with some aspects of the management of a construction project. Exchange of experiences will be encouraged through a few exercises and case studies.

E. Biosafety audits and inspections – a basic course

Peter Guldbrandsen, Former Head Corporate HSE Audit Novartis,Ettingen/Switzerland
Helmut Bachmayer, Biosafety & Biosecurity Consultant, Maria Enzersdorf/Austria

Short description:
This workshop is intended to provide a basic course on auditing management systems and monitoring safety performance in connection with activities involving biohazards. In addition to setting out the general framework for the audit process, and contrasting this with safety inspections, a number of scenarios will be presented to illustrate some of the difficulties which may be encountered, along with approaches to circumvent these. Points to consider when planning and conducting an audit will be presented together with useful hints based on the auditing experience of the tutors. Based on a case study, audit preparation and strategy as well as communication will be practiced in group work and role playing.

F. Biosafety in laboratory animal facilities

Kathrin Summermatter, Institute of Virology and Immunoprophylaxis, Mittelhäusern/Switzerland
Stéphane Karlen, Ecole Polytechnique Federale de Lausanne (EPFL), Lausanne/Switzerland
Jürgen Mertsching, Hannover Medical School, Hannover/Germany

Short description:
The first part of the workshop is dedicated to presentations on the basic principles of animal biosafety. An overview about safety measures (operational, work practices, equipment) that relate to small and large animals will be given, including a particular focus on risk assessment of both infected (e.g. animal models for human diseases) and genetically modified animals. Emphasis will be put on containment measures as well as on personal protective equipment.
In a second part the case study approach will be used to allow participants to work in smaller groups to recognize, to discuss and to assess the hazards and associated risks related to animal handling. Participants are invited to bring their own case studies or send their case studies in advance to Kathrin.Summermatteratvi.admin.ch

G. Biosafety professional and its counterparts

Danielle Caucheteux, Glaxo Smith Kline Biologicals, Rixensart/Belgium
Ursula Jenal, Jenal & Partners Biosafety Consulting, Rheinfelden/Switzerland
Martin Kuster, Novartis International AG, Basel/Switzerland

Short description:
The BSO and the biosafety network: organisation of coordination and collaboration with stake-holders in biosafety and related safety areas

 This workshop covers the interaction and collaboration of the BSP with other stakeholders concerned with biosafety such as scientists, laboratory personnel, the biosafety committee and the management as well as stakeholders concerned with other safety areas such as environ-mental health and safety advisors, occupational health physicians, security managers, facility managers, maintenance personnel…. The purpose of the workshop is to identify and establish ways to have positive and effective interactions with stakeholders and to use synergies through expedient collaboration and coordination.

Examples of the structuring of the biosafety network will be presented and the problems re-lated to the coordination and collaboration in biosafety management will be addressed, illus-trating the situation in industry, in academia and in hospital settings. In addition, participants will work in smaller groups on case studies discussing specific problems of interaction and coordination on the basis of a management checklist thereby developing solutions or strate-gies of improvement. Participants are invited to contribute their own questions, problems, solutions and experience. At the end of the workshop, participants will share their results in a plenary session and discuss solutions hopefully applicable to their own work environment.