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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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Component Type: Session

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 Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for David Martin

David Martin

Associate Director, RWE Analytics, Office of Medical Policy, 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
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
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