Speakers at Pre conference course C. Recombinant virus and viral vectors for research, gene therapy and vaccination: “GMO or not? Safe or not? Manageable or not?
Pre conference course C. Recombinant virus and viral vectors for research, gene therapy and vaccination: “GMO or not? Safe or not? Manageable or not?
About the speakers
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Myra Widjojoatmodjo
Academic Education and Degrees:
PhD. Faculty of Medicine, Utrecht University, The Netherlands
MSc. Molecular Sciences, Agricultural University, Wageningen, The NetherlandsPresent Professional Position
Scientific Director Global Environmental Risk Assessor
Environmental Product Compliance and Sustainability, Global Sustainability, Janssen R&D (since 2019)Currently responsible for the Environmental Risk Assessments of Janssen R&D product portfolio: chemicals (API SM) and biologicals, including genetic modified organisms [GMO]s) for Marketing Authorization and clinical trials
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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 UniversityPresent Professional Position
Since 2001, executive manager of Jenal & Partners Biosafety Consulting advising industry, academia and authorities on an international level on all issues related to biosafety and biosecurity: risk assessment of contained use activities; risk assessment of nano-bio-materials; environmental risk assessment for gene and cell therapy and recombinant vaccine clinical 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.
Member of EBSA since 2001, acting as secretary for 4 years, member of the Education and Training Working Group until 2018 and representing EBSA at the Biological and Toxins Weapons Convention meetings. She has been co-chair of the CEN workshop process to develop the CWA16335 on BioSafety Professional (BSP) competence, and is now project leader of the development of the ISO Technical Specification TS5441 Competence Requirement for Biorisk Management Advisors.