Thursday, October 11th, 2018 - Amsterdam
Official language: English
The world of clinical research is in a phase of profound transformation.
As we enter the era of precision healthcare, scientists and researchers are exploring new ways to evolve the drug development process so that treatment advances can be matched to specific patients and potentially reach them even earlier.
The acceleration of this scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials with new drugs. It is associated with a profound methodological transformation, which leads to overcoming the classical model of development.
To ensure rapid access to patients for new drugs and to contain high development costs, regulatory authorities, FDA and EMA, show a readiness to accept new approaches ranging from new experimental designs, to early access models, to management of some aspects of the development with a “risk based” approach, up to the opening of the use of Real Word Evidence data.
In this context, the operators involved in the management of clinical research are facing new important challenges. A few examples: implementation of electronic Informed Consents, protocols based on personalized healthcare, patient involvement, etc. All these changes require a different approach by all stakeholders: pharmaceutical & biotech companies, CROs, Research Centers and Health Authorities.
The question is: is the BeNeLux ready to cope with the transformation in clinical research?
Isabelle Van der Haegen - Country Head of Clinical Operations Department Belgium at Roche
Isabelle D’hondt - Study Start-Up Manager. Country Clinical Operations Belgium at Roche
Jeananne Bär - Team Manager Clinical Study Unit The Netherlands at Sanofi
They will lead a panel of experts to share best practices, knowledge and experience in this field.
Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments:
• Clinical Research and Development
• Quality Assurance
• Clinical Operations
• Statistics and Data Management
• Information Technology
• Market Access
Taking part in the event, you support “The Vase of Flowers” project