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The Digital Transformation of Clinical Trials and its Regulatory Implications – What are the Challenges?
Session Chair(s)
Mireille Muller, DrSc, PhD, MSc
Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
Digital technology and novel approaches to clinical trial conduct have the potential to simplify the clinical trial process to become more patient-centric. What are the regulatory challenges and hopefully solutions for using these tools in clinical trials of the future?
Speaker(s)
Challenges Using Digital Tools in Clinical Research
Nitharna Sivarajah
Medicines and Healthcare products Regulatory Agency, United Kingdom
Pharmacovigilance Information Coordinator - Direct Reporting lead
FDA View
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE
The Importance of Software and Apps in Healthcare – Regulatory Considerations
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
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