Dr. Inge Berthold

Development, implementation and maintenance of a quality management system for clinical research at the DHM (German Heart Center Munich) Planning, conduct and oversight of audits acc. to GCP as well as related GXP requirements Ensuring inspection readiness regarding authority inspections and client audits; management of authority inspections

Department management incl. team management and consultants Implementation and maintenance of applicable regulations: GLP, GCP, GCLP, GVP and GMP based on EU and US regulations such as FDA CFR, OECD, ICH, AMG, EU Directives and euqivalent Implementation of QMS such as EDMS, eCR and eCAPA Relationship and operational management with authorities; hosting and management of authority inspections Planning, conduct and oversight of audits (all compliance areas)

Planning and conduct of immunization studies Development, optimization and validation (ICH) of an ELISA Participation in two collaborative studies (at CDC and LMDQC) Participation in the establishment of a QMS at CBER (according to ISO17025) Staff training