Managing Digital Therapeutic Approvals (Live Online)

Our new digital health series offers four programs that provide executives in the healthcare and life science industries with immediate, actionable insights in light of the current pandemic and its economic aftermath. The last program in the series is Managing Digital Therapeutic Approvals (Live Online), taught by Columbia Business School Professor Frank Lichtenberg and Chair of digital health testing center HITLAB, Stan Kachnowski.
 

Faculty Co-Director Frank Lichtenberg

Dates: November 10–12 and 17–19, 2020
Duration: 6 days over 2 weeks
Time: 11 a.m.–2 p.m. ET per program day
Format: Live, virtual sessions
Fee: $4,350

This program earns 3 certificate credits. Learn more.



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Inquiry Form [MDTA]

Program Overview

Managing Digital Therapeutic Approvals (Live Online) 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

Schedule

» Download the program schedule here.

AMA PRA Category 1 Credits™

The November 10–19, 2020 iteration of the Managing Digital Therapeutic Approvals program has been approved for up to 18 AMA PRA Category 1 Credits™ to “serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships” as stated in the AMA’s definition of CME†.

Faculty

Frank Lichtenberg
Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business
Columbia Business School

Frank Lichtenberg is Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business at Columbia Business School, a research associate of the National Bureau of Economic Research, and a member of the CESifo Research Network. He previously taught at Harvard University, the University of Pennsylvania, and Ecole Polytechnique. He has served as an expert for the Federal Trade Commission, the U.S. Dept. of Justice, and state Attorneys General, and has testified before Congress. He has worked for several U.S. government agencies, including the Department of Justice, the Congressional Budget Office, and the Census Bureau, and been a visiting scholar at the Wissenschaftszentrum Berlin, the University of Munich, and elsewhere.
 

Stan Kachnowski
Chair
HITLAB

Stan Kachnowski is the Chair of the digital health organization HITLAB. He is an Oxford trained researcher who has taught over 5,000 students from Columbia University, IIT-Delhi, and Quinnipiac College. His teaching and research over the past 25 years include educating graduate-level and executive students on four continents and conducting extensive studies on the efficacy and diffusion of digital health, including electronic data capture, ePRO, wearables, and predictive algorithms.



Sign Up for Program Updates

Inquiry Form [MDTA]

Questions?

Please contact our Faculty Co-Director Stan Kachnowski at [email protected].



 

 

†AMA CREDIT DESIGNATION STATEMENT
The Columbia University Vagelos College of Physicians and Surgeons designates this live activity for a maximum of 18.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

†ACCREDITATION STATEMENT
The Columbia University Vagelos College of Physicians and Surgeons is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.