16th – 18th April, 2018

London, UK

Pre Conference Workshop A
Monday, 16th April, 2018

09.00 - 12.00
Disrupting the Status Quo in mHealth & Rethinking the Clinical R&D Model

Pharma is heavily investing in the implementation of innovative mobile and digital health approaches in their clinical studies. Over the years, incremental improvements in patient centricity and in valuable insight being collected from these tools have been gradually changing the way we look and understand clinical trials – but is this enough? Should we start completely afresh, and rethink the way clinical research is done – through true disruption
and transformation?

In a thought-provoking discussion led by David Goren, a pharma veteran and expert in the digital innovation space, you will be sure to leave inspired by a collaborative open dialogue on how to disrupt the model and truly put the patient at the center of clinical research.

Key topics to be discussed include:
• Main hurdles faced in planning, setting up and conducting clinical trials that could be solved with digital tools and
methodologies
• Internal challenges to changing the way we operate – innovation as a driver for success
• External challenges – the role and positioning of external stakeholders including regulators
• Patient centricity from start to finish
• How do we truly start from patient needs?
• Is there a bridge from R&D to commercial through digital?
• How could digital make a clinical trials also support the goal of RWE generation for payors without risking meeting
targets and goals?

Join this interactive and comprehensive session that will allow you to better streamline and boost innovative mHealth approaches in clinical programs that match the potential of your drug candidates.

Workshop Leader: David Goren, Strategic Consultant, Epione Strategy, Ltd., former VP, Digital Health Innovation, AstraZeneca

Pre Conference Workshop B
Monday, 16th April, 2018

13.00 - 16.00
Navigating the Regulatory Frameworks for mHealth Applications in Clinical Research

More than ever, Europe is now focusing on the rapidly evolving legal and regulatory aspects facing mHealth applications. The biopharmaceutical sector, in particular, is striving to incorporate innovative mobile health initiatives and tools in their drug development process. Questions around how to make sure their endeavours are compliant with current regulation and new guidelines around data collection and validity are key focus points.

In this focused session, Professor Lucien Rapp shares his thoughts and opens this topic up for collective discussion. With extensive expertise in regulation and legal aspects of the mobile world, this workshop will allow you to fill in the gaps and delve into the regulatory shift of mHealth applications in clinical research and
development.

Key topics to be discussed include:
• Analysing the regulatory perspectives on the evolving landscape in the mHealth space and the legal challenges
of mHealth in Europe
• Regulators views on digital health in clinical research – acceptance, openness and guidance
• Discussing the influence of the new GDPR EU regulation in the future of mHealth strategies in pharma
• Evaluating data privacy, sharing and ownership issues underlying the application of mobile tools in the clinical context

Join your peers for a wide-ranging debate on the legal and regulatory limits to digital innovation in clinical trials, and make sure your studies are prepared to face 2018.

Workshop Leader: Lucien Rapp, Senior Consultant, Watson Farley & Williams, Professor, University of Toulouse1-Capitole