Celerion: Risk Management Workshop

Risk management in global clinical trials environments - the academic, sponsor and CRO perspectives


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 by Fri, May 3, 2019.
For questions,please contact Alexandra Seifert at +491602612304

Thu, 9.5.2019 | 15:30 - 18:30

Steigenberger Hotel Herrenhof
Herrengasse 10
1010 Vienna

Celerion Invitation Workshop Vienna