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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND


Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

Session Chair(s)

Mireille  Muller, DrSc, PhD, MSc

Mireille Muller, DrSc, PhD, MSc

Regulatory Policy & Intelligence Director

Novartis Pharma AG, Switzerland

Multiple trial design options are required to increase efficiency in clinical trial conduct in increasingly complex conditions and smaller populations while maintaining scientific value and data quality to meet the wants of all stakeholders.

Learning Objective : i) identify and discuss the problems, also ethical and economical, related to phase II planning; ii) evaluate if the techniques adopted for planning phase II are correct, in order to collect enough information to plan the subsequent, eventual, phase III; iii) influence the decisions about phase II planning.


Michael  Krams, MD

Platform Trials

Michael Krams, MD

Janssen R&D, Johnson & Johnson, United States

Vice President, Global Head of Quantitative Sciences

Sacha  Wissink, PhD

Regulatory and HTA Challenges with Innovative Clinical Trials

Sacha Wissink, PhD

MSD Netherlands, Netherlands

Executive Director, Regulatory Affairs Europe

Benjamin  Hofner, PhD

Regulator’s Perspective: Master Protocols – Risks and Benefits

Benjamin Hofner, PhD

Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany

Head of Data Science and Methods

Daniele  De Martini, PhD

Empowering Phase II Clinical Trials To Reduce Phase III Failures

Daniele De Martini, PhD

Milano-Bicocca University, Italy

Associate Professor

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