GMP / GLP / GCP
is a pharmacist. She studied public finances and law at the Dalian Maritime University in China and pharmacy at the University of Erlangen-
Nuremberg. After finishing her studies, she worked in QA, QC and Regulatory Affairs for various companies such as ratiopharm, TEVA Ulm, and Boehringer-Ingelheim Biberach.
In 2021, 2 draft guidelines about computerized systems and Digital Health Technology (DHT) in clinical investigation were published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The following article is a brief summary about the FDA DHT draft guidance with consideration of the EMA draft guideline.