Speakers at EBSA Thursday "Risk assessments – One size does not fit all"

EBSA Thursday "Risk assessments – One size does not fit all"

About the speakers

  1. Toon De Kesel

    Toon De Kesel

    Present Professional Position

    Biorisk & EHS Expert
    Toon De Kesel is owner and general manager of Febris Biorisk Consult BV, a specialist company providing leading consultative services worldwide in the areas of Biosafety and Biosecurity. He founded Febris Biorisk in 2016. He led several WHO GAPIII IPV/OPV Polio-virus projects at various companies, e.g. Janssen Vaccines BV, Intravacc and Bilthoven Biologicals BV (NL), Praha Vaccines as (CZ), GSK Vaccines NV (BE), Sinovac Ltd (China).

    Previous experience

    Toon De Kesel was, for more than 15 years (until 2008), Corporate Manager Health, Safety and Environment at Innogenetics NV, a Belgian biopharmaceutical company. He was the biosafety officer for both Innogenetics’ R&D and Bio-manufacturing plants (vaccine production facilities). He has relevant experience in dealing with general safety aspects, occupational health and environmental issues, regulatory matters, laboratory and manufacturing (biosafety) practices, biocontainment facilities and risk assessment involving biological agents (including GMO’s/GMMO’s). He has lots of expertise in technical issues such as risk analysis methodologies, job hazard analysis, work practices, personal protection, disinfection, waste management, emergency procedures, training op personnel, etc. Specific experience in regulatory matters, laboratory and manufacturing practices, high biocontainment facilities - (A)BSL-3), all in relation to EHS and Biosafety.  

    He then joined, in 2008, DNV Biorisk as Principal Consultant Biorisk, specializing in risk assessment associated with biological systems, and in particular studies relating to laboratory biosafety and biosecurity measures. He was performing risk assessment and safety studies, i.e. HAZOP risk assessment of an effluent treatment plant, SWIFT risk assessment of a HVAC installation, and organizing and giving biorisk training courses. 

    He was appointed from 2009 to 2016 as Biosafety International Compliance Manager for Bayer Cropscience NV in Gent and was the Global Head of Biological Material Movement. In 2010, he was appointed as the Environmental Safety Manager for the Belgian activities of Bayer Cropscience until December 2014. 

    He is member of the European Biosafety Association since 1998, and was the EBSA President 2013-2014. He is Chair of the EBSA CWA Strategy Task Group and was member of the EBSA Education and Training Working Group and BTWC/CBRN Task Group. He is a member of the ISO/TC-212 Working Group 5 - Biorisk Management (ISO 35001:2019) and other ISO Biorisk management deliverables (Biorisk management guidance document and Biosafety professional competence). 

    He was closely involved in the foundation of Belgian Biosafety Professionals (BBP) in 2005 and is Past-Chairman of the BBP (2005-2008). He is Council Member of the Flemish Association for Environmental coordinators (VMx) since 2000. He was former Board Member of the International Federation of Biosafety Associations (IFBA), 2014-2017.

  2. Ursula Jenal

    Ursula Jenal

    Working address:

    Jenal & Partners Biosafety Consulting,
    Magdenerstrasse 1
    4310 Rheinfelden
    Switzerland

    Tel:+41 61 723 28 58
    Email:ursula.jenal@jenalpartners.ch

    Academic Education and Degrees


    PhD in Microbiology from the Swiss Federal Institute of Technology, ETH, Zürich, Post Doc in Environmental Engineering and Sciences at Stanford University

    Present Professional Position

    Since 2001, executive manager of Jenal& Partners Biosafety Consulting advising industry, academiaandauthoritieson an international levelon all issues related to biosafety and biosecurity: risk assessment of contained use activities of all levels; risk assessment of nano-bio-materials; environmental risk assessment forgeneand celltherapy and recombinant vaccineclinical trials and market authorisation applications; guidelines on safe use of cell cultures, plant pathogens, transport, waste treatment; biorisk management systems, crisis management, biorisk management audits, ISO140001 audits, biosafety training, safe procedure design, project management.

    Special Remarks

    1996-2000 senior scientist at the Swiss Federal Office for the Environment acting as co-author of the Swiss Biotechnology Regulations harmonised with the corresponding EU directives. Representing Switzerland at the OECD working group on harmonisation of regulatory oversight in biotechnology and the European Enforcement Project of Biosafety Regulations. Member of EBSAsince 2001, acting as secretary for 4 years and representing EBSA at the Biological and Toxins Weapons Conventionmeetings. She participated in the CEN workshop agreement process to design the CWA15973Biorisk Management Standard and has beenco-chair ofthe CEN workshopprocessto develop theCWA16335 on BioSafety Professional (BSP) competence, thereby repre-senting Switzerland.

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