Pre conference course B - Auditing: a comprehensive and practical introduction - Instructors
Pre conference course B - Auditing: a comprehensive and practical introduction
About the speakers
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Gijsbert van Willigen
Gijsbert van Willigen is the biosrisk management professional of the Leiden University Medical Center in the Netherlands. After his study Biology at the Catholic University of Nijmegen (1987), he did his PhD at the Academic Hospital Utrecht in the field of thrombosis and hemostasis (1992). After several post-doc positions at the University Medical Center Utrecht and a sabbatical at the University of Helsinki (2000) he started as a biosafety Officer at the UMC Utrecht. In 2002 he switched to the Leiden University Medical Center and since then has a position as biosrisk management professional. Since 2020 he is also the biorisk manager at the Netherlands Center for the Clinical advancement of Stem Cell and Gene Therapies (NecstGen).
As a biosafety officer he has been admitted by the Dutch authorities for several containment levels up to (A)BSL3. His field of expertise include biosafety and biosecurity in diagnostic and research laboratories and animal experiments in high containment facilities ((A)BLS3). He is a renowed expert in the use of genetically modified organism in a clinical setting (gene therapy). He has been involved the construction of several BSL3 facilities in the Netherlands and is now involved in the construction of a new GMP-facility for NecstGen.
Over the years he was part of many national and international committees on biosafety and biosecurity, dual-use research and gene therapy. Since 2017 he is a representative of the Dutch Federation of University Medical Centers in committees for the modernization of the regulatory framework for biotechnology in the Netherlands and the EU especially for the use of biotechnology in humans. Furthermore he was a speaker at several national and international conferences and a trainer in biosafety courses.
Between 2014-2018 he was member of the council of the European Biosafety Association; President of EBSA in 2016-2017.
Further details see: http://nl.linkedin.com/in/gvanwilligen
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Per Staugaard
Per Staugaard [1952] studied Biochemistry and Chemical engineering at Amsterdam University. He worked as a chemistry teacher on secondary school for some years.
Per has been involved in biosafety since he started working at the vaccine production at the Dutch National Institute for Public Health [RIVM] in 1989. As head of bacterial vaccine production he was responsible for erecting a new production building, creating a GMP and BSL-2 compliant production environment. After the transfer of his department to the Foundation for Public Health [SVM] in 1997 he was responsible as well for the training program in the vaccine department as for [bio]safety. With the start of the Dutch vaccine Institute [NVI] in 2002 he focussed on biosafety. From 2011 until mid 2015 he worked at RIVM as senior Biosafety Officer.Since 2003 He has been active as an independent biosafety consultant next to his work for RIVM. He used to be also the Biosafety Officer for some smaller companies and institutions, including pharmaceutical manufacturing, research labs and musea. He has been involved in development of in-house biosafety training for companies and regularly contributes as teacher/ speaker in biosafety courses. He advised on technical items for containment, as killtank systems, laboratory and equipment design. Per is nowadays early retired; He assists younger colleagues in training assignmants an in audits.
Per is acknowledged as a Registered Biosafety Professional by the Americanbiosafety Association [ABSA] and is a honorary member of the European Biosafety Association [EBSA].
Academic Education and Degrees- Biochemistry [University of Amsterdam] 1981
- Chemical engineering [University of Amsterdam] 1985
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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 experienceToon 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.