Matthias Loibl
Angestellt, Senior Manager Clinical Compliance, Gedeon Richter Plc.
Abschluss: MSc, London School of Hygiene and Tropical Medicine
Wien, Österreich
Werdegang
Berufserfahrung von Matthias Loibl
Bis heute 1 Jahr und 3 Monate, seit Apr. 2023
Senior Manager Clinical Compliance
Gedeon Richter Plc.
12 Jahre und 1 Monat, März 2011 - März 2023
Senior Expert Inspector GCP
AGES
- 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
1 Jahr und 4 Monate, Okt. 2009 - Jan. 2011
Scientific Administrator - GCP/PhV Inspections
European Medicines Agency
-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
2 Jahre, Okt. 2007 - Sep. 2009
Clinical Research Associate / Clinical Monitor
i3 Research
- 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
7 Monate, Aug. 2006 - Feb. 2007
Diploma Student
AGES
- 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
1 Jahr und 2 Monate, Juni 2005 - Juli 2006
Student Assistant
ABCSG
- 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
Ausbildung von Matthias Loibl
4 Jahre, Okt. 2014 - Sep. 2018
Clinical Trials
London School of Hygiene and Tropical Medicine
5 Monate, Aug. 2014 - Dez. 2014
Quality Management Systems
Quality Austria
3 Jahre und 10 Monate, Sep. 2003 - Juni 2007
Medical and Pharmaceutical Biotechnology
University of Applied Sciences IMC Krems
Pharmaceutical Development and Production (GCP, GMP, GLP)
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
Spanisch
Grundlagen