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?

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Pre conference course C. Recombinant virus and viral vectors for research, gene therapy and vaccination: “GMO or not? Safe or not? Manageable or not?

Wednesday, 19 April 2023 09:00 - Wednesday, 19 April 2023 17:00 (CET) EBSA , EBSACourse , course , preconference , Advanced , 2023

About the speakers

  1. Myra Widjojoatmodjo

    Myra Widjojoatmodjo

    Academic Education and Degrees:

    PhD. Faculty of Medicine, Utrecht University, The Netherlands
    MSc. Molecular Sciences, Agricultural University, Wageningen, The Netherlands

    Present 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

  2. Ursula Jenal

    Ursula Jenal

    Working address:

    Jenal & Partners Biosafety Consulting,
    Magdenerstrasse 1
    4310 Rheinfelden
    Switzerland

    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

    Attendance of numerous biosafety trainings ABSA, EBSA
    ISO9001 certified lead auditor

    Present 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; ISO35001 biorisk management systems and audits, crisis management, ISO140001 certification audits, biosafety training, safe procedure design, project management. She has been involved in capacity building projects in South East Asia.

    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.  

    Member of the certification body of IFBA representing EBSA 2016 – 2020.  

    Co-chair of the CEN workshop process to develop the CWA16335 on BioSafety Professional (BSP) competence, and project leader for the development of ISO Technical Specification TS5441 Competence Requirement for Biorisk Management Advisors.