When:
22.10.2015 at 14:00 o’clock (CEST)
Duration – 1 hour.
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(Registration form is below)
Description:
In a court, one is innocent until proven guilty, in the drug development business one is guilty until proven innocent.
Therefore, every pharmaceutical company aims at the conduct of clinical trials in the most genuine way. One of the most important mechanisms to realize this goal is the monitoring of clinical sites. Monitoring is considered as one of the most expensive activities (approx. 30% of overall trial’s budget). Understanding what risks influence the outcome of a study can make monitoring more resource efficient.
During a clinical trial, hundreds of aspects can go wrong: logistics, patient recruitment, technology, and patient safety can be jeopardized. To know when and at what area to focus on and to have a plan of actions when something fails is a very clever strategy.
(Registration form is below)
During this webinar you will learn:
First part:
- What risk-based study management is
- How to enhance time and financial control
- How to achieve precision in project planning
- Efficiency in organizing & staffing
- Excellence in leading & directing
Second part:
- What the next upcoming GCP change will bring
- How to construct a good Risk-defense Strategy for your trial
- What technical solutions for RbM exist and how they differ
- What the steps for embracing RbM are and how to plan the transition period
New: Get your named certificate after the training!
Speakers:
Artem Andrianov, PhD, serves as Managing Director for Cyntegrity Germany GmbH. He combines verified skills in management and leading international teams (China, Germany, India, the US, and elsewhere) with vast experience in developing software for the pharmaceutical industry, and has been responsible for numerous successful software projects in clinical data quality oversight. After graduating as a software engineer, Dr. Andrianov earned his PhD in Mathematical Methods, and an Executive MBA from Cass Business School.
María Proupín-Pérez, PhD, serves as a Project Leader for the premium German CRO PPH plus. She combines deep theoretical knowledge about Risk-based monitoring and practical experience as CRA and project manager of clinical trials. After her Chemistry study at her home university, Dr. Proupín-Pérez obtained her Ph.D. in Organic Chemistry at the University of Liverpool (UK) in 2006, and the Project Manager Professional certification in 2015. Her therapeutic areas of expertise are hemophilia, meningitis C, septic shock, atrial fibrillation, stroke and myocardial infarction. Dr. Proupín-Pérez is a member of the DGPharMed and the Project Management Institute (PMI).