EBSA10 Preconference Courses 2007
A. Export, import and transport of biological materials, including GMOs, from a practitioners point of view
Kristel Vermeersch, KVS & Partners, Dangerous Goods Consultants, Kampenhout, Belgium
Patrick Rüdelsheim, Perseus BVBA, Zwijnaarde, Belgium
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!
B. Biosafety audits and inspections - A basic course
Peter Guldbrandsen, Head Corporate HSE Audit, Novartis International AG, Basel, Switzerland
Helmut Bachmayer, Biosafety & Biosecurity Consultant, Vienna, Austria
This seminar 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 practised in group work and role playing.
Allan Bennett, Health Protection Agency, Salisbury, UK
Peter Hoffman, Laboratory of Healthcare Associated Infections, London, UK
Steve Copping, HSE Biological Agents Unit, Bootle, Merseyside, UK
This seminar is intended to promote understanding of current approaches to fumigation and disinfection. It will also deal with the impact of regulatory changes including the Biocidal Products Directive.
D. A Training Program in a Biosafety Environment
Per Staugaard, Biosafety Training and Consultancy, Utrecht, The Netherlands
Otto Doblhoff-Dier, Onepharm Research and Development GmbH, Wien, Austria
This seminar is intended to provide a basis to set up a training & qualification program in connection with activities involving biohazards. After an introduction to training in general and more specifically to education, knowledge and experience, The trainees will set-up in small groups a training program for an imaginary workplace. Specific attention is paid to different training methods and to evaluation of training.
E. Biosafety management. Policy and procedures; structures within organisations
Heather Sheeley, Health Protection Agency, Wiltshire, UK
The management and organisation of Biosafety is important to ensure that biological risks are properly controlled and that this can be demonstrated to auditors and regulators. Effective systems for Biosafety are equally applicable to Biosecurity control. This workshop will explore the high level management and local arrangements typically used. There will be discussion of the types of arrangement, the levels, roles and responsibilities and training. Thus should appeal to those wishing to set up a Biosafety or biosecurity system or improve on current arrangements.