Tuesday, June 19th, 2018 - Frankfurt am Main
Official language: German
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, which leads to overcoming the classical model of development based on the sequentially managed phases for individual New Chemicals Entities and New Biological Entities.
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.
• What is the evolution of skills, processes and tools in pharmaceutical & biotech companies, CROs and research centers, also in view of the regulatory changes taking place?
• What organizational changes will the stakeholders in clinical research have to face and which are the priority areas?
• How much does the technological evolution in digital health care, will 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?
• Changing role of patient involvement in clinical trials.
• The right balance between complexity, speed and quality: Is Germany ready to cope with the transformation in clinical research?
Martine Dehlinger-Kremer, Vice President, Global Scientific and Medical Affairs, Synteract & EUCROF President, Heike Schön, Managing Director, LUMIS International and Herbert Eskötter, Medical Consultant, 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