Managing Digital Therapeutic Approvals

Columbia Business School

How long?

  • 6 days
  • online

Columbia Business School

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About the course

Managing Digital Therapeutic Approvals is designed to provide an intensive dive into the regulatory and legal landscape for the successful management of digital therapeutic approvals. Participants will learn the necessary strategies and features to ensure regulatory compliance for their digital therapeutics.

Learning Outcomes

  • Develop strategies for implementing technologies, policies, and monitoring for digital therapeutic approvals
  • Understand and navigate the regulatory framework in the US that governs digital therapeutic approvals
  • Examine factors of successful digital therapeutic approvals using real-world case studies
  • Learn to successfully assess and mitigate regulatory risks

Topics

Day 1

Introduction to Managing DTX Venture and IP

Day 2

  • The Pharma Value Creation: Process Standard in Medical Technology and Innovation
  • Digital Rx Approval Pathways

Day 3

  • Digital Strategies for Operational Excellence
  • Being a Leader with Digital Ethics

Day 4

  • Designing a DTx Solution
  • Designing and Running a Clinical Development Program for DTx

Day 5

  • Quality Management
  • Regulatory Development

Day 6

  • Healthcare Operations Integrations
  • Reimbursement

Experts

Frank Lichtenberg

Biography Frank R. Lichtenberg is Courtney C. Brown Professor of Business at the Columbia University Graduate School of Business; a Research Associate of the National Bureau of Economic Research; and a member of the CESifo Research Network. He received a BA with Honors in History from the Univers...

Stan Kachnowski

Stan Kachnowski, Faculty Director Professor of Health Information Management in the division of Policy and Management at the Mailman School of Public Health at Columbia University Professor Stan Kachnowski, PhD MPA CSEP, an Oxford trained researcher, has taught over 5,000 students from Columbia ...

Managing Digital Therapeutic Approvals at Columbia Business School

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