The Association of Medical Ethics Committees in Germany prepares statements on draft laws and regulations at German and European level. You can find these below.
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Stellungnahmen
09/12/2020
Comments on COM Implementing Decision on standard contractual clauses for the transfer of personal data to third countries pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council (PDF|211KB)
Stellungnahmen
27/09/2019
Comments on ICH Draft ‚General Considerations For Clinical Studies E8(R1) (PDF|367KB)
Stellungnahmen
13/08/2019
Comments on ICH Draft ‚Optimisation of Safety Data Collection E19 (PDF|985KB)
Stellungnahmen
30/07/2019
Comments on EMA Draft ‚Questions and answers on Data Monitoring Committees Issues (PDF|657KB)
Stellungnahmen
27/10/2018
Comments regarding the Consultation Document Good Clinical Practice for Advanced Therapy Medicinical Products (PDF|308KB)
Stellungnahmen
09/02/2011
Comments concerning the Revision of the ‘Clinical Trials Directive’ 2001/20/EC (PDF|130KB)
Stellungnahmen
21/03/2010
Statement of the Permanent Working Party of Research Ethics Committees in Germany concerning the ‚Draft Guide for Research Ethics Committee Members‘ of the Council of Europe CDBI/INF (2009)6 (PDF|149KB)
Das Logo des Arbeitskreises zeigt den Kentauren Chiron, den Sohn der Nymphe Philyra und des Kronos. Chiron war der Lehrer des Asklepios (Aesculapius) und galt in der Antike als mythischer Schutzpatron der Medizin.