Matthias Loibl

- GCP inspection program coordination - GCP inspections (national and EMA procedures, drug trials and medical device trials) - GVP inspections - Member of the EU GCP Inspectors Working Group - GCP inspectors' Trainer - Internal quality auditor

-Organisation of the quarterly PhV IWG meetings -Coordination of GCP- & PhV Inspections in the course of marketing authorisations for the centralised procedure. -Validation of the GCP & PhV aspects of marketing authorisation applications -Contribution to the development of a database for the management of GCP & PhV inspections -Regulatory advice to internal and external stakeholders with regards to GCP & PhV aspects of the dossier and inspections; Trainee from October 2009 to March 2010

- Routine site monitoring activities (selection, initiation, interim and close-out visits) of phase III and phase IV Oncology trials (Multiple Myeloma, NSCLC, Melanoma) - Study start-up activities of a phase III Analgesics trial (Oncology patients) including, feasibility activities, pre-study visits, preparation and translation of study documents, communication with regulatory authorities and site supply and medication management

- Set up of a database for GCP inspection results - Data management of GCP inspection results - Statistical evaluation of findings - Support of GCP inspectors at inspection sites - Support of QM in establishing SOPs - Diploma Thesis: Regulatory Framework and State-of-the-Art Conduction of Clinical Trials in Austria - Evaluation of the Compliance of Clinical Trials with ICH-GCP and the Austrian Law on Basis of GCP-Inspections

- Data management in the course of the submission phase of a phase III Oncology study to FDA - Support of project management - Support of regulatory affairs

Pharmaceutical Development and Production (GCP, GMP, GLP)