Thursday, May 31st, 2018 - Copenhagen
Official language: English
The world of clinical research is in a phase of profound transformation.
The acceleration of scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials with new drugs. This increase in studies is associated with a profound methodological transformation.
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 future use of Real Word Evidence data.
In this context, the operators involved in the management of clinical research are facing new important challenges.
• What is the evolution of skills, processes and tools in pharmaceutical companies, CROs and research centers, also in view of the regulatory changes taking place?
• What organizational changes will we implement to adapt to a new environment, and which are the priority areas?
• How will the healthcare technology evolution influence the way of doing clinical research?
• What is the point of view of investigators/physicians, study nurses, research coordinators and data managers working in this sector who are experiencing this transformation?
Martin Holm-Petersen, CEO at Insife and Jesper Kjær, Manager for the IMPACT, portal and eTrials support department within Clinical Systems, Data and Trial Management (CSDTM), Clinical Operations at Novo Nordisk A/S, scientific board of the event, 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