Back to Agenda
Session 7 Track 2: Emerging Technologies and Data Driven Initiatives Within the Regulatory Environment
Session Chair(s)
Jo English
VP and General Manager, Enterprise Technology
Calyx, 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)
Speaker
Vada Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Speaker
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Speaker
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Head of Information Management
Speaker
Taha Kass-Hout, MD, MS
Amazon Web Services, United States
Chief Medical Officer and Director of Health AI
Have an account?