Mag. Andreas Raffeiner
CEO | Clinical Monitor / CRA | Project Manager | Data protection Officer
andreas.raffeiner [at] studien-monitor.at
Mag. Andreas Raffeiner
Curriculum vitae
Education
1999
Graduation with a degree in Social economics, Linz
1999
Proficiency Certificate „Health Care Manager“ for Monitor/CRA qualification, Vienna, Austria
2012
Concluded examination for quality managers and internal quality auditors
2011
Competence certificate "GCP-Auditor"
2015
Certificate "Apprentice Trainer"
2015
Authorization for "Labour Leasing"
Work Experience
1994 to 1995
Firma Astra (Zeneca), Field representative; Respiratory domain
1995 to 1996
Firma Astra (Zeneca), Field representative; Cardiovascular domain
1996 to 1997
Firma Astra (Zeneca), Hospital representative; domains Gastrointestinal and pain management
1997 to 2000
Firma Astra (Zeneca), Clinical Research Manager in charge of the conduct of medicinal product studies in the gastrointestinal, respiratory and cardiovascular clinical domains
2000 to 2002
Firma Quintiles, Clinical Research Associate, home-based. In charge of the - medicinal product studies in the gastrointestinal, cardiovascular and CNS fields.
2002
Self-employed, Conduct of clinical trials involving medicinal products for human use
Special skills
Foreign languages
- German (mother tongue)
- English (confident in business and discussions)
Computer skills
MS-Office und Internet - excellent
Other
- International coach for study data compilation over the internet (Web-based Data System COOL und RAVE) with international training experience in 10 EU countries
- Provided training to over 200 principal investigators (study doctors) and monitors
- Monitor reporting system (IMPACT) coach
Lecturing activities, contracted by an independent pharmaceutical firm
- Practical monitoring
- Essential study documentation
- Project management in clinical trials
- Patient informed consent&briefing
- Principal investigator workshops
Lecturer at the University of Applied Sciences Krems (IMC Fachhochschule Krems), Austria
- Health care management > clinical trials
Lecturer at the Danube University Krems (Donau-Universität Krems) in collaboration with CenTrial GmbH Tübingen, Germany
- University study program "Master of Science - Clinical Research"
Lecturer at Johannes Kepler University Linz in collaboration with the Clinical Trial Unit (Akademie für Gesundheit und Bildung der Kreuzschwestern ) in Wels, Austria.
- University study program "Clinical Research"
Experience
Experience
Phases II - IV
GASTROENTEROLGY (> 300 patients)
- Dyspepsia
- H. pylori eradication
- GERD (gastrointestinal reflux disease)
- Stomach protection during NSAID therapy
- Peptic ulcer bleeding
- Chronic inflammatory bowel disease
HEMATOLOGY (> 400 patients)
- Prophylaxis against deep vein thrombosis (DVT) and pulmonary embolism following extensive orthopedic surgical interventions
RHEUMATOLOGY (> 300 patients)
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Systemic juvenile idiopathic arthritis
DERMATOLOGY (> 20 patients)
- Psoriasis
BONE DISEASES (> 50 patients)
- Osteopenia and osteoporosis
- Osteoarthritis
METABOLIC DISEASES (> 40 patients)
- Diabetes mellitus type 2
RESPIRATORY DISEASES (> 100 patients)
- Bronchial asthma
- COPD
CARDIOLOGY (> 120 patients)
- Hypertension
- Heart failure
- Cardio-renal end point study in diabetes mellitus type 2
CENTRAL NERVOUS SYSTEM (> 100 patients)
- Schizophrenia
- Acute ischemic stroke
- Alzheimer's disease
- Depression
NON-INTERVENTIONAL STUDIES IN CORE THERAPEUTIC AREAS:
- Rheumatology (patients)
- Metabolism (patients)
- Psychiatry (patients)
- Nephrology (50 patients)
- Data compilation in case report forms, and transfer of data by way of regular mail, fax and electronically (modem und web-based data capture).
Training details
Training details
10/05/1995
Professional title Pharmaceutical representative – Examination board at the Federal Ministry for Health and Consumer Protection, Vienna, Austria
11/18/1997
Study program: "Monitor – The liaison between the sponsor and the investigator
11/20/1998
"Basic Course on Clinical Trials", Sweden
01/28/1999
Certificate of Proficiency: "Health Care Manager"; professional activity: Monitor / CRA
01/24/2000
Certificate of Proficiency (update): "Health Care Manager"; professional activity: Monitor / CRA
12/18/2002
Training on "MedDRA essentials" Version 5.0
05/19/2003
seminar diploma: Performance Optimization in Clinical Trials
07/01/2003
IMPACT coach training: Modules Host and Portable
11/05/2003
Seminar diploma: Amendment to AMG, Implementation of the EU directive 2001/20/EC in Austria
02/03/2004
IMPACT Training
02/17/2004
Seminar diploma: EU Directive 2001/20/EC on ICH / GCP
10/06/2004
Seminar: INSPECTION -A challenge faced by the investigator
11/08/2004 to 11/12/2004
CRA Compliance Training, Hungary
11/30/2004
Seminar diploma: AMG Amendment 2004 – Clinical Trials NEW – Initial experience and further development
06/24/2005
Seminar diploma: Study Management Advanced
12/09/2005
Seminar diploma: Data Protection in Medicine
02/27/2006
Seminar diploma: AMG Amendments 2005 & 2006 - Update Legal provisions governing clinical trials
02/28/2006
Seminar diploma: No need to fear GCP audits and inspections
11/16/2006
Seminar diploma: Post-marketing Surveillance Studies
03/19/2007
Seminar diploma: Pharmacovigilance Compact
04/24/2007
Seminar diploma: The new data protection law
06/22/2007
Electronic Data Capture (EDC): RAVE training course, EDC Train the Trainer, Version 5.5
11/26/2007
Global RAVE EDC 5.6 Webex
11/30/2007
Seminar diploma: Law on Medicinal Products
09/19/2008
Seminar diploma: Neurology and Psychiatry Workshop Sophie Förster-Streffleur, MD
02/20/2009
Seminar diploma: Intensive Immunology Sophie Förster Streffleur, MD
07/16/2009
Intramural continuing education seminars:
- Patient Information in Minors/Children
- News from the seminar "Study Management Advanced"
- Conduct of a Close out visit
- Workshop "How can I positively influence the recruiting process?"
02/26/2010
Intramural continuing education seminars:
- News from the Seminar "Medicine Products Act"
- News from the Seminar "Pharmacovigilance Compact"
- Management Manual Mag. Andras Raffeiner GmbH
03/15/2010
Seminar diploma: Data Protection in Clinical Trials
06/17/2010 to 06/18/2010
Team Seminar Communication, Mag. Erwin Datscher, ProConsult, St. Stefan am Walde
07/23/2010
Seminar diploma: TBC Infection and Disease in Immunosuppressed Patients
09/24/2010
Seminar diploma: Oncology, Beate Mayrbäurl, MD, Linz
03/31/2011
Seminar diploma: Ethics committee in clinical research, Univ.-Prof. Dr. Ernst Singer, Vienna
10/10/2011 to 10/11/2011
Seminar: The GCP Auditor, Vienna
11/17/2011 to 11/18/2011
Seminar: Coding with MedDRA, Jochen Stecher, MD, Berlin
03/20/2012
Workshop: Stressmanagement, Gabriele Selb, Linz
04/23/2012
Seminar: Psychology of auditing, Vienna
03/06/2012 to 06/01/2012
Training as a certified quality manager, TÜV Austria Academy, Vienna
06/14/2012
Seminar: Clinical research in the press / public, Vienna
12/06/2012
Seminar: Early Phase Clinical Research - An un(used) opportunity in global competition for Austria?
03/12/2013
Driver Safety Training 1
04/22/2013 to 04/23/2013
Presentation seminar
06/06/2013
Clinical research in Austria and Europe: Quo vadis?
09/21/2013
GCP training: study-specific documentation in the medical history
10/23/2013
Open access to clinical trial data?
11/04/2013
Professional teams invest in themselves
11/26/2013
Developments, changes and news in clinical research
11/28/2013
Is it a step forward or does it backfire?
04/10/2014
Seminar diploma: "mental health at work", Mag. Robert Brandstetter, Faustschlössl, Feldkirchen a.d. Donau
04/11/2014
In-Company training
- Clinical Trial Regulations, neue EU-Directive
- ELGA - Elektronische Krankenakte
- Investigator initiated trials
- Adaptive Monitoring
- optimal process of monitoring visits
09/20/2014 to 12/06/2014
staff leasing - Preparation for exam
11/04/2014 to 11/17/2014
Instructor training
11/27/2014
E - health and telemedicine - Opportunities and new challenges in Clinical Research
12/18/2014
staff leasing: Module 1
12/18/2014
staff leasing: Module 2
01/19/2015
Exam: staff leasing
03/26/2015
The Authority as an industrial advisor: from scientific advice to patient access
04/21/2015 to 04/22/2015
Spring Meeting
- GCP Findings 2013, FDA-Findings
- Compassionate Use
- Medical device law with DI (FH) Dr. Michael Ring
07/20/2015 to 07/21/2015
Summer Meeting
- Seminar diploma: Time Management, Mag. Erwin Datscher, Pro Consult
07/21/2015
Training: How to use a fire extinguisher, FF Walding
12/16/2015 to 12/17/2015
Conflict Resoultion in the Clinical Trial, HealthCare Consulting GmbH
04/20/2016
Project Management-Tools for Clinical Trials, HealthCare Consulting GmbH
04/25/2016
Electronic Data Processing in Clinical Trials, GxP Konkret
05/03/2016
Workshop on Implementation of ISO 9001:2015, TÜV Austria
06/09/2016
Registry - Real World Evidence - but how?, GPMed
09/15/2016
Crisis Management in Clinical Trials, GPMed
09/30/2016
GCP Refresher, QBEX
10/05/2016
Clinical Evaluation in the Life Cycle of Medical Devices and IVDs, University of Applied Sciences Upper Austria
11/17/2016
Symposium: Clinical Trials, KKS Innsbruck
12/12/2016
Patient Education in Clinical Trials, GxP Konkret
06/14/2017
Study medication and IMP, GxP Konkret
06/22/2017
New Clinical Trials regulation and their practical impacts on clinical studies in Austria, GPMed
06/26/2017 to 06/28/2017
Education on General Data Protection Regulation, TÜV Austria Akademie
06/29/2017
3. CRCS FORUM Clinical Studies, CRCS GmbH Salzburg
09/21/2017
Data protection in the pharmaceutical industrie, Dr. Gerhard Kunnert and Dr. Rainer Knyrim
10/19/2017
TÜV Qualityday 2017, TÜV Austria Akademie