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Thursday, June 18 • 8:00am - 9:00am
#405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-727-L04-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly medicine development utilizes digital technologies including digital therapeutics with the potential to provide transformative treatment opportunities. Challenges to the current regulatory framework need to be translated into opportunity. This session will discuss examples of complex healthcare solutions and analyze enabling factors to facilitate their progress from early proof of principle to market access.

Learning Objectives

Describe how digital (therapeutic) technologies are transforming drug development and their regulation; Identify opportunities on how to catalyze for more integrative approaches in the development and regulation of medicines and digital (therapeutic) technologies; Discuss scientific and regulatory opportunities how to enable the integration of digital (therapeutic) technology in medicines development.

Chair

Falk Ehmann, MD, PhD, MS

Speaker

Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support Offered by FDA
Bakul Patel, MBA, MS

Floodlight Development: A Case Study
Seya Colloud, PharmD

Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support by EMA
Armin Ritzhaupt, PhD, MPH



Speakers
avatar for Falk Ehmann

Falk Ehmann

Chair of Innovation Task Force, European Medicines Agency
Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal... Read More →
avatar for Seya Colloud

Seya Colloud

Global Regulatory Director, F. Hoffmann-La Roche Ltd
Seya Colloud is a pharmacist by training and holds a Masters in International Drug Regulatory affairs from University Paris-Sud, (France). She works as Global Regulatory Director in the personalized healthcare team for F. Hoffmann La Roche in Switzerland. Her area of expertise and... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Center of Excellence (DHCoE), CDRH, FDA, United States
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate... Read More →
avatar for Armin Ritzhaupt

Armin Ritzhaupt

Scientific Administrator, European Medicines Agency
Armin Ritzhaupt, is a scientific administrator in the Regulatory Affairs Office at EMA providing regulatory support to development, evaluation and surveillance of medicinal products for human use with a focus on activities related to the implementation of the new medical device and... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session