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Overview

This conference will explore the macro trends affecting RWE across the lifecycle of medicines from development to post approval market use. Advanced analytics and integrated solutions are taking RWE use to the next level, inviting conversations about the quality of different types of RWE sources and how to best approach a unified framework for clinical data collection. We will discuss how RWE can support regulatory, physician and health care provider decision-making as well as optimization of clinical trial design. Join the discussions about patient involvement in RWE design and discover how various stakeholders are leveraging RWE to advance healthcare knowledge and decision-making processes as they are increasingly delegated to AI and related technologies.

Featured topics

  • Using RWE to support regulatory decision making
    • What do Regulators say? – Challenges / Cases Studies of RWE for Regulatory Purposes
    • Safety vs. Efficacy
    • Industry insights – Cases Studies
  • Understanding the compliance gap – validating patient centric endpoints and outcomes with RWE
  • Enhancing Patient involvement in RWE design
  • Adopting RWE to fine-tune the design and efficiency of randomized clinical trials
  • Using analytics to support Clinical Trials Outcomes and RWE- Case Study
  • Leveraging analytics: next-generation clinical decision-making systems
  • Informing product and therapy - What Are the Data Sources of the Future?
    • Including overview: which RWD data sources support which purposes (covering quality requirements, applicable standards etc.)?
  • Using RWE to enhance the design and efficiency of randomized clinical trial

Who should attend?

  • Real World Evidence
  • Epidemiology
  • Policy
  • Regulatory Science
  • Data Science
  • Personalized healthcare
  • Data and analytics
  • R&D big data

Learning objectives

  • Explain and demonstrate different uses of RWE in the design of Clinical Trials
  • Clarify the usage of analytics in supporting Clinical Trials Outcomes and RWE
  • Discuss patient involvement in RWE design
  • Showcase a patient-focused, clinical outcome assessment (COA)

Program Committee

  • René  Allard, PhD
    René Allard, PhD self
    Self, Germany
  • Frederik  Floether, PhD, MA, MSc
    Frederik Floether, PhD, MA, MSc IBM Q Industry Consultant - Global Lead Life Sciences & Healthcare
    IBM, Switzerland
  • Sophie  Janssens
    Sophie Janssens Vice President, Global Head of Real World Evidence
    UCB Pharma, Inc, Belgium
  • Michael  Lees
    Michael Lees Head of Value, Evidence and Portfolio Strategy – EUCAN
    Takeda Pharmaceuticals International GmbH, Switzerland
  • Inger  Mollerup, MS, MSc
    Inger Mollerup, MS, MSc Consultant
    Inger Mollerup Regulatory Consulting, Denmark
  • Michael   Seewald
    Michael Seewald Worldwide Head Real World Evidence and Digital
    Novartis Pharma AG, Switzerland
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