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Wednesday, February 6 • 15:15 - 16:15
#S0703: The Digital Transformation of Clinical Trials and its Regulatory Implications – What are the Challenges?

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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?

Chair

Mireille Muller, DrSc, PhD, MSc

Speaker

Challenges Using Digital Tools in Clinical Research
Nitharna Sivarajah

FDA View
David Martin, MD, MPH

The Importance of Software and Apps in Healthcare – Regulatory Considerations
Maria Isabel Manley, LLM


Speakers
avatar for Marie Manley

Marie Manley

Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP
Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Mireille Muller

Mireille Muller

Regulatory Policy Director, Novartis Pharma AG
Mireille Muller Ph.D. has over 19 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, and technology-enabled clinical trials... Read More →
NS

Nitharna Sivarajah

Pharmacovigilance Information Coordinator - Direct Reporting lead, Medicines and Healthcare products Regulatory Agency
Nitharna graduated in Natural Sciences at the University of Cambridge. She joined the Medicines and Healthcare products Regulatory Agency (MHRA) in 2015 and swiftly built her knowledge in pharmacovigilance across a range of roles, from case processing to signal management. As a Pharmacovigilance... Read More →

Wednesday February 6, 2019 15:15 - 16:15 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  07 Digital Disruptors, Session
  • Featured Topics Data and Data Standards
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