Agenda
15:30-16:00 h Welcome, Networking and Refreshments
16:00-16:10 h Host Opening Remarks
16:10-18:00 h Dimensions of Risk Management in Global Clinical Trials Environment:
The Academia Perspective:
- What is risk management as perceived by a clinical trial site
- How a clinical trial site would collaborate with a CRO and with a Sponsor to mitigate risks
- Case studies
The Sponsor Perspective:
- Sponsor oversight in clinical trials
- Identify, assess, mitigate and review risks
The Contract Research Organisation Perspective:
- Positioning the level of involvement of sponsor and CRO
- How your vendor can help
- Principles, Processes and Practicalitie
18:00-18:30 h Q & A
Gues speakers
Michael Wolzt
- MD from the University of Vienna in 1991 and post-graduate research at the University College London, UK
- Professor of Medicine and internal medicine consultant at the Vienna General Hospital
- More than 20 years of experience in industry-sponsored and non-commercial clinical trials with human medicines and medical devices
Ghazaleh Gouya Lechner
- CEO and founder of Gouya Insights
- Austrian board certified in Internal Medicine, Cardiology and Clinical Pharmacology
- Leadership in clinical development for biotechnology companies
- Over 20 years of experience in the areas of clinical trials as Investigator (FIH to Phase IV)
Space is limited. Please RSVP at marketing@celerion.com by Fri, May 3, 2019.
For questions,please contact Alexandra Seifert at +491602612304