Wednesday, November 21st, 2018 - Paris

Official language: French

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Clinical research 2.0

Strategic, organizational, infrastructural, and quality aspects

The world of clinical research is in a phase of profound transformation.

The acceleration of scientific knowledge in recent years is leading to a significant increase in the number of clinical trials with new drugs. This increase in study number is associated with methodological transformations.

To expedite market access to new drugs and to contain development costs, regulatory authorities, FDA and EMA, show readiness to accept new approaches including alternative experimental designs, early access models, risk based management of a numerous aspects of drug development pathway, use of Real Word Evidence data.

In this context, the operators involved in management of clinical research are facing a number of new challenges such as:

• What is the required evolution of skills, processes and tools in pharmaceutical companies, CROs and research centers, in the context of regulatory changes taking place?
• What organizational changes will be needed to adapt to this new environment, and which are the priority areas?
• How will the healthcare technology evolution (big data, sensors, e health, Artificial Intelligence etc.) influence the way of doing clinical research?
• What is the feedback of investigators/physicians, study nurses, research coordinators and data managers working in this sector who are experiencing this transformation, what are the consequences on their activities, what are the requested skills, how can they accommodate these changes?

We are sure you will be as passionate as we are on these novel topics, the future is here, we need to shape it for providing enhanced solutions for a better health and quality of life for patients. This meeting will be a key opportunity to network and learn from knowledgeable speakers and experts of the area.

Scientific Board

Anna Cali - Global Medical Affair Head Diabetes&Cardiovascular New Product and Integrated Care at Sanofi
Erick Gaussens - Executive Advisor and Chief Scientific Officer at ProductLife Group
Bertrand Sohier - Global Head, Respiratory, Critical Care, Cardiovascular and endocrinology Therapeutic Areas at PAREXEL

They will lead a panel of experts to share best practices, knowledge and experience in this field.

Who should attend?

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
• Regulatory
• Pharmacovigilance
• Clinical Operations
• Statistics and Data Management
• Information Technology
• Market Access

Please click here to read the code of good conduct

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