ISO/TS5441:2024 Competence Requirements for Biorisk Management Advisors: what it is, how to use it
In spring 2024, the International Organization for Standardization, ISO, published the technical specification ISO/TS5441:2024 Competence Requirements for Biorisk Management Advisors (BMA). ISO/TS5441 compiles all information on required knowledge, skills and experience a biorisk management advisor should have to provide competent advice to an organization under a given context, that is, based on the types of activities with biological material and their risk. ISO/TS5441 helps you to demonstrate and update your competence and it supports organization on how to define their competence need and how to choose a BMA. ISO/TS5441 has been designed by biosafety experts from different countries around the globe based on consensus, thus being a truly international specification.
The course will inform BMA of all degree of expertise and fields of activities on how ISO/TS5441 supports biorisk management advice activities. ISO/TS5441 can be purchased from national standardization organisations. The document cannot be shared as proprietary. However, this is not a prerequisite for attending the course.
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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 UniversityAttendance of numerous biosafety trainings ABSA, EBSA
ISO9001 certified lead auditorPresent 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.