Tine Lykke Bank
Senior Consultant at Genau & More- Claim this Profile
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Danish Native or bilingual proficiency
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English Full professional proficiency
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German Elementary proficiency
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French Elementary proficiency
Topline Score
Bio
Credentials
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Current Good Manufacturing Practice (cGMP). Validation Qualification and Compliance Requirements, and Electronic Records and Electronic Signatures
Genau & More A/SNov, 2016- Nov, 2024 -
GMP Up-dates
Key2Compliance®Jan, 2014- Nov, 2024 -
Good Clinical Practice (GCP) Brush-up, Changes and Updates
Aarhus UniversityJan, 2014- Nov, 2024 -
Good Manufacturing Practices (GMP), Basic and Brush-up
Key2Compliance®Jan, 2014- Nov, 2024 -
Good Clinical Practice (GCP), Clinical Trial protocol, Case Report Form, Quality Assurance, Conduct of the Trial, Monitoring, Adverse Reactions and Adverse Events, Regulatory Approval.
Aarhus UniversityJan, 2011- Nov, 2024
Experience
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Genau & More A/S
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Denmark
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Business Consulting and Services
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1 - 100 Employee
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Senior Consultant
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2014 - Present
Genau & More is a highly specialized consulting company solely working in Life Sciences. We offer specialist knowledge and resources at senior level within compliance, regulatory, quality assurance & control, manufacturing processes and GMP IT & Automation. At Genau & More we are striving to build and develop long-term relationships with our clients build on trust. Jointly with our clients, we lead the field of compliance & quality and together we shape a future based on collaboration-driven excellence. Compliance & quality is a shared dedication. Key responsibilities: > Project Consultant > Equipment documentation: Strategic long-term inspection readiness program > Basic and Detailed Design Documentation > Test and Qualification Protocols Show less
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Aarhus University
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Denmark
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Research
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700 & Above Employee
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Project Coordinator
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1992 - 2014
The Department of Public Health encompasses a number of academic disciplines within the field of public health. The research is characterized by a high degree of interdisciplinarity and cooperation with national and international researchers. The Department of Public Health engages in activities of benefit to public health. The Department has a long history of knowledge exchange and cooperation with public institutions, including municipalities, regions, hospitals, general practices and interest groups, and finally private Life Science companies. Key responsibilities: > Planning of New Projects > Establishment of Trial Master Files > Establishment of Case Report Forms > Recruitment of Clinical Trial Subjects > Specification, Description and Implementation of Standards and Procedures > Regulatory Approval at Public Authorities > Conduct of Trials > Validation Documentation Show less
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Education
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Aarhus Universitet
Project Management -
Erhvervsakademi Aarhus / Business Academy Aarhus
Bachelor’s Degree, Chemical and Biotechnical Science -
Lillebaelt Academy of Professional Higher Education
Laboratory Technician, Clinical Laboratory Science/Medical Technology/Technologist