Clinical Trials – the Greek Legal Framework

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A full update on clinical trials legislation in Greece. Contents include:
Ι. Clinical Trials Legal Framework
ΙΙ. New Clinical Trials Legislative Framework (ΔΥΓ39(a)/18910/21.2.2013 suppl. Directive 2001/20/ΕC)
Approval Process
Types of Studies
III. Personal Data Protection (Law 2472/97 DIRECTIVE 95/46/EC) in the light of
New Ministry Decision
a. Patient Consent in Clinical Studies
IV. Legal Liability/Indemnity
Insurance Coverage
V. Intellectual Property & Patents (Law 2121/1993)


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