Dissertation committee:
Καθηγήτρια Δήμητρα Παπαδοπούλου – Κλαμαρή (Νομική, ΕΚΠΑ)
Καθηγήτρια Ευγενία Δακορώνια (Νομική, ΕΚΠΑ)
Ομότιμη Καθηγήτρια Ανθή Πελλένη – Παπαγεωργίου (Νομική, ΕΚΠΑ)
Καθηγητής Δημήτριος Λιάππης (Νομική, ΕΚΠΑ)
Αναπληρωτής Καθηγητής Μιχαήλ Αυγουστιανάκης (Νομική, ΕΚΠΑ)
Επίκουρος Καθηγητής Θεόδωρος Λύτρας (Νομική, ΕΚΠΑ)
Επίκουρος Καθηγητής Παναγιώτης Νικολόπουλος (Νομική, ΕΚΠΑ)
Summary:
Clinical trials are a complex, costly and time-consuming process that aims to verify the safety and efficacy of new medicinal products and treatments. History itself, with the recent pandemic of COVID-19, has shown that clinical trials can give answers to complex questions and offer solutions to health emergencies. The current thesis describes the contractual relationships created between the parties involved in a clinical trial (sponsor, hospital, principal investigator, participant/patient). In parallel, the thesis deals with potential civil liability (both tortious and contractual) of the parties. Finally, the thesis analyzes two specific issues that are of great concern and interest, i.e. the protection of personal data in the context of clinical trials and the conduct of remote (virtual) clinical trials, which is part of the general conversation about, with all the consequent challenges posed by, eHealth.
Keywords:
clinical trials, medicines, medicinal products, drugs, pharmaceuticals, EU law, liability, product liability, contracts, data privacy, GDPR, health, ehealth, digital health, medical devices, CRO, marketing authorization, research and development, compliance, regulatory law, pharmacovigilance, COVID-19, vaccines, patient, doctor, investigator, hospital, pharmaceutical company, pharmaceutical law, health
