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National Institute for Public Health and the Environment
Ministry of Health, Welfare and Sport
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Gene Therapy Office
Gene Therapy Office
History
Overview of assessment bodies
Assessment procedures
Tips for the applicant
Preliminary consult
Preliminary consult
Assessment frameworks
Preparation by the investigator
Organisation
Application form
Application form
Part A: Biosafety aspects
Part B: Patient-related aspects
Ongoing study
Ongoing study
What to do in the event of changes to the research
What to do in the event of adverse events and unexpected circumstances
Periodic reports and notifications
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