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Virtual

Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 2: Emerging Technologies and Data Driven Initiatives Within the Regulatory Environment

Session Chair(s)

Jo  English

Jo English

Chief Strategy Officer

Ennov, United Kingdom

Health Authorities and industry recognize the benefits for more efficient and effective decision making, but can they keep pace with emerging technologies? This session will describe how data and technology modernization requires active collaboration with regulatory authorities and other stakeholders and will review the principles of informatics, data management and data governance as they apply to regulatory acceptability. A case study on Real-World Data (RWD) and Real-World Evidence (RWE) will be presented to provide an example of how this is being applied. The session will present regulatory and scientific perspectives from regulators, industry, and life sciences data/tech sector on emerging technology and its application to regulatory initiatives to further advance public health.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Demonstrate awareness of data driven initiatives within the global regulatory environment
  • Identify emerging technologies and their application to regulatory advances
  • Understand the need for new tools standards and approaches to assess the safety, efficacy, and quality of regulated products

Speaker(s)

Vada A. Perkins, DrSc, MSc

Speaker

Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

Mary Ann  Slack

Speaker

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Hilmar  Hamann, PhD

Speaker

Hilmar Hamann, PhD

European Medicines Agency, Netherlands

Head of Information Management

Taha  Kass-Hout, MD, MS

Speaker

Taha Kass-Hout, MD, MS

Amazon Web Services, United States

Chief Medical Officer and Director of Health AI

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