Expertise

Our experience encompasses all areas of biosafety and biosecurity be it in industry, academia, authorities or open space.

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Biological risk assessment

  • Evaluation of notifications and authorisation applications according to the contained use regulation, activities of class 1 to 4, for the Swiss Federal Office for the Environment, FOEN, since 2001

  • Comparison of safety measures of high containment level 4 facilities (Canada, Sweden, Germany, USA) and application to Swiss regulatory requirements

  • Evaluation of activities combining nanoparticles with biological materials

  • Evaluation of environmental risk assessments based on the Swiss ordinance on major accidents for high containment facilities

Biorisk management

  • Up-date of biorisk management system regarding biosecurity, since 2018

  • Safety data sheets and procedures manuals for ATMPs for industry

  • Design of bio- and chemical risk management systems for industry and academia, Swiss Federal Institute of Technology, Okinawa Institute of Science and Technology Graduate University (OIST), EAWAG Aquatic Research Institute. Examples from industry upon request

  • Biorisk management for several biopharmaceutical and biotech companies, as external biosafety advisor or temporary advisor, Belgium, Luxemburg, Switzerland, since 2011

  • External project management for the reconstruction of the Swiss Institute of Virology and Immunology (IVI), in particular project lead in the development of the epidemic management plan, the emergency preparedness and response management plan and the biosecurity management plan

  • Technical support for biorisk management in institutions

  • Preparation and submission of notification and authorization request files for contained use activities on account of various academic and private organizations, Ph. Stroot (Belgium, Luxemburg)

  • Technical safety measures for greenhouse contained use systems (GM plants and arthropods)

  • Waste treatment of infectious substances and GMO

  • Support for the purchase of technical equipment (decontamination autoclaves, effluent decontamination systems…)

  • Review and redesign of decontamination and disinfection programs

  • Advising on the selection of personal protective equipment

  • Review of mycotoxin handling practices for a European Commission Reference Laboratory

  • Criteria for risk assessment of plant pathogens

Technical support to regulatory authorities

  • Design of guidelines for regulatory authorities and expert committees

  • Classification of exotic, potentially invasive invertebrate species

  • Advising of authorities for the design of a comprehensive biosafety regulation, Ph. Stroot, Tunisia, 2012-2013

  • Expertise for the formulation of risk management strategies, more particularly to include GMOs in the strategies to control invasive species, Cameroon, 2014-2015

  • Formulation of recommendations to improve biorisk management and biowaste management capacities at national level, for various individual Southeast Asian countries, as part of EU CBRN CoE Project 46, 2015-2018

Audits and inspections

  • Biosafety regulation compliance inspections for the enforcement authorities of the Canton de Vaud, Switzerland, inspecting academia, industry and hospital diagnostic and research institutions (U. Jenal)

  • Biorisk management audits in academic, industry and public laboratories, since 2001 (Europe, Marocco, Asia)

  • Evaluation of Biosafety versus Good Manufacturing Practices/Good Laboratory Practices and Quality Assurance, since 2010. Examples from industry upon request

  • ISO14001/ISO9001/OHSAS18001 management system audits (for SGS Société Général de Surveillance) 2006-2013 (U. Jenal)

  • Technical, risk-based management audits of effluent decontamination systems and other technical facilities for the industry (Europe, North America, Asia)

  • Audit preparedness for various organizations, including in the Polio eradication (GAPIII) context (Ph. Stroot)

Design and construction

  • Biosafety expertise for the design, construction and commissioning of R&D, diagnostic and production BSL1, BSL2 and BSL3 facilities (Ph. Stroot), Belgium, France, Pakistan, India

  • Definition of the containment measures and technical advising for the design and construction of BSL2 greenhouse for GMO plants, for an international institution, Mexico

Training

  • Training on dual use potential of biological research for the University of Geneva, 2016

  • Development of a 5-day-course in biosafety as member of the Education and Training Working Group of the European Biosafety Association since 2012

  • Pre-conference courses on biological risk assessment and risk assessment methodologies for the European Biosafety Association since 2006

  • Training workshops for the Belgian Biosafety Professionals, 2006-2015

  • Training workshops for the Pakistan Biological Safety Association, since 2011

  • Training on risk assessment, viral vectors and transport for biosafety professionals, Swiss biosafety professional training, since 2009

  • Biosafety in medicine and biorisk management training for safety engineers for the Swiss Federal Institute of Technology, since 2013

  • Biosafety trainings for scientists and biosafety coordinators in academia and industry

  • Tailored internal training on biosafety programs and procedures for academic and private organizations

  • Train-the-trainer biosafety, biosecurity and biorisk management workshops for various European, African and Asian countries, as part of EU CBRN Projects 3, 6 & 46 (2014-2018)

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