Wie sicher sind klinische Studien? Die Durchfiihrung klinischer Studien erfordert hochste Sicherheitsstandards zum Schutz der Teilnehmer. Pharmakovigilanz ist diesbeziiglich unverzichtbar.
Learn the most common CTIS submission mistakes in Part I and Part II documents. Submit your EU CTIS without delays.
Early-stage biotech companies often contact the EMA too late. Learn when and how to request an EMA Innovation Task Force (ITF) meeting, how it differs from Scientific Advice, and what to prepare before your first ITF EMA engagement.
Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials
