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Future of Evidence and Smart Health Conference

Leveraging RWE to advance healthcare decision-making.


Session 1: Regulatory Landscape RWE and Digital Health - Challenges and Opportunities

Session Chair(s)

Virginia  Acha, PhD, MSc

Virginia Acha, PhD, MSc

  • Global Lead, Global Regulatory Policy
  • MSD, United Kingdom

Traditionally, the term “digital health” could be simply defined as using technology to help improve individuals' health and wellness. However, the area of digital (or smart) health has been rapidly evolving over the last decade and is now considered a diverse yet complicated space which could encompass everything from eHealth and mHealth (wearable tech and devices) to AI and Machine Learning (ML), from Digital endpoints and biomarkers to digital therapeutics, and from robotics to electronic health records (EHRs). Many of these have relevance and application within the regulatory setting in terms of evidence generation and use within regulatory decision making.

Real World Data (RWD) / Real World Evidence (RWE) is another emerging field of great interest for application in the regulatory space, yet is often viewed and treated as a separate, stand-alone topic from digital health. This could be due to the fact that RWD and its application in regulatory submissions and decision making is already more mature than some of the digital health applications, in addition to the fact there are numerous concept-specific considerations to the application of RWD/RWE not necessarily applicable to digital health. However despite this, the reality is that digital health and RWD are themes which are inherently linked, especially when we consider the fact that much of the data identified, collected and subsequently analysed through new digital technologies can in fact be considered as RWD to support decision making, and hence makes it challenging to discuss and debate one without the other.

The concept of this interplay and relationship between digital health and RWD/RWE underpins the unique narrative and flow for this two-day DIA workshop which will involve both joint sessions but also separate digital health and RWD/RWE track sessions.

This opening session will introduce you to the evolving global regulatory landscape for digital health and RWD/RWE and through discussion with regulators and industry members from across the globe will debate what these topics mean in their respective areas and what are the emerging regulatory opportunities and challenges these novel digital fields are currently presenting us.

Speaker(s)

Andrew  Raven, MSc

Pre-Market RWE Post-COVID: Challenges and Opportunities

Andrew Raven, MSc

  • Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
  • Health Canada, Canada
Frank  Petavy, MS

The EMA Perspective

Frank Petavy, MS

  • Head of Methodology
  • European Medicines Agency, Netherlands
Gustavo  Mendes Lima Santos, MPharm

Use of Safety Database to Generate Evidence

Gustavo Mendes Lima Santos, MPharm

  • General Manager of Medicines and Biological Products
  • ANVISA, Brazil
Álmath Máire Spooner, PhD, RPh

Panel discussion with the additional participation of:

Álmath Máire Spooner, PhD, RPh

  • Director of Regulatory Policy and Intelligence
  • AbbVie, Ireland

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