Pre conference course H - Biosafety in a GMP World - Instructors
EBSA course
Pre conference course H - Biosafety in a GMP World
About the speakers
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Gesche Bernhard
Educational qualifications
Dr. Bernhard holds an MSc in Biology (focus microbiology) and a PhD in Biochemistry (Biomedicine) from the Free University Berlin and Charitè - University Medicine, Berlin. In addition, she holds a Master of Advanced Studies in Business Law and has furthered her education in corporate governance and management.Current Position
Currently, Dr. Bernhard is an expert consultant for biosafety and biocontainment at Basler & Hofmann AG, Switzerland.Experience
After more than 10 years of experience in basic biomedical research (immunology, oncology and glycobiology) she moved to pharmaceutical industry in Switzerland.
There, she worked for 12 years in various positions, as an innovation manager, GMP project manager and as the site's biosafety officer. She also advised other sites in Europe and abroad, participated in the design process of various new builds, ensured the site`s biosafety compliance (trainings and implementation of biorisk management system, documentation, audits, etc.) and represented the company to clients and authorities. She also acted as environment, health and safety (EHS) coordinator for new construction and refurbishment projects.
Since joining Basler & Hofmann, Dr. Bernhard has been involved in numerous BSL2 and (A)BSL-3 design developments and peer reviews, in biorisk management develop-ments, staff trainings and audits as well as in BSL4 and GAPIV projects.
She is a member of the Swiss Biosafety Network, the European Biosafety Association and the American Biological Safety Association and acted as lecturer in conferences, trainings and workshops.
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Karen Gjendal
Educational qualifications
Dr. Gjendal Gmünder holds an MS Veterinary Medicine and a PhD in Lifescience from the University of Copenhagen in Denmark.Current Position
Currently, Dr. Gjendal is the Biosafety Officer at Bavarian Nordic A/SExperience
Karen Gjendal is the Biosafety and Biosecurity Officer at Bavarian Nordic, a leading vaccine company with a commercial-scale manufacturing facility in Kvistgaard, Denmark. Bavarian Nordic specializes in the production, analysis, and release of sterile vaccines for human use, adhering to stringent EU cGMP standards. The product portfolio includes vaccines for Smallpox, Rabies, and Tick-Borne Encephalitis, with several innovative, life-saving vaccines currently in development.
Karen is responsible for establishing and maintaining a comprehensive Biorisk management program. This involves implementing and optimizing protocols to mitigate safety and security risks associated with the handling, storage, and disposal of biological agents and toxins within the production facility. Additionally, she ensures that all implemented Biorisk Management processes comply with GMP requirements, thereby safeguarding both the products and the personnel.
Karen specializes in Biorisk Management training across site, performs risk assessments, give input to optimizations of systems supplying the facility, equipment or training programs.
Member of:
Danish Biorisk management ERFA network
Nordic Biosafety Network Forum
ABSA & EBSA Membership