The Ethics Committee (hereinafter referred to as the “EC”) by Pavelec LENTE, Ltd. is an independent committee established by Pavelec LENTE, s.r.o. The EC consists of five members who are appointed by the head of Pavelec LENTE, s.r.o.
The EC works in accordance with the Act No. 378/2007 Coll., on Pharmaceuticals, as amended; Ministry of Health and Ministry of Agriculture Regulation No. 226/2008 Coll. as amended; The Declaration of Helsinki developed by The World Medical Association; and relevant European Commission Directives (Clinical Trials Directive 2001/20/EC as amended by 90/2006, and The Good Clinical Practice Directive 2005/28/EC).
The purpose of the EC is to asses submitted projects of clinical trials from ethical, scientific and medical perspectives. The EC is dedicated to protecting the health, rights and dignity of human subjects involved in clinical trials.