Irina Bart

Initiation and Conduction of Clinical Trials: Submissions to Ethics Committees and Regional Authorities - Providing On-site Study Files & Pharmacy Study File - Maintaining the Electronic Study File with all relevant study documents - Correspondence with Sites - documentation and tracking in project specific systems - Eclipse update - SOPs und system Trainings - Study Team Meetings and international communication at BMS - successful implementation of the Project § 42b AMG

Monitoring of Clinical Trials - Regulatory Affairs: CTD and major Guidelines/Direktive for drugs/ medical devices - Pharmacovigilance - AMG, UWG, HWG - Pharma Market Access - Product and Project Management - Quality Management, Quality Assurance (GLP, GMP) - Business Administration and Marketing - Case-Study „IMA 901“