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Smarter Clinical Trials with Real World Evidence Data

How Can We Enable Clinical Research in Europe Further?

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:

Room Number:


Smarter Clinical Trials with Real World Evidence Data

Holger Maria Rohde, PhD, MBA, MSc
Director Regulatory Project Management
Merck KGaA, Germany

In the session we will discuss innovative ways to leverage RWD/RWE to optimise clinical trial design, such as the fine-tuning of a targeted population, improvement of site selection and patient recruitment, but also to complement traditional development in changing (or increasing?) regulatory requirements. How can we increase efficiency of clinical trial design, mitigate against avoidable delays and costs, and unlock advanced “what if” scenario planning options in the trial design process? What kind of data and design can complement evidence from clinical trials, in which situations this could be helpful to fulfil regulatory requirements?

Presentation(s) & Speaker(s):
Will RWE Replace Evidence Coming from Clinical Trials in the Future?
Patrice Verpillat
Head of Global Epidemiology
Merck KGaA , Germany

How Can Real World Data Improve the Early Clinical Development Process?
michel Francois Denarie, MBA
Sr. Principal, Data Scientist
Quintilesims, United States

The Role of Real World Data in the Regulatory Setting
Aldana Mariela Rosso, PhD
Senior Adviser Biostatistics
Danish Medicines Agency (DKMA), Denmark