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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

On Demand 1 Track 1: IRISS Forum Hot Topics

Session Chair(s)

Jake  Doran

Jake Doran

Vice President, Digital

Lykos Therapeutics, United States

Since 2012, IRISS has taken a leadership position across the regulatory landscape and has grown to be a place where regulatory professionals come to not only learn, but also contribute to cultivating the future of the regulatory profession. In this session, topic leads from the following IRISS Topic Groups will share the latest developments and discussions from their respective IRISS communities: GSO, ePI, and digitalization in regulatory.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the latest developments and discussions related to Electronic Product Information generally and ePI activities in Europe
  • Have awareness of the latest hot topics in submissions operations
  • Better understand the potential and practical applications of emerging technologies in Regulatory, including AI and RPA

Speaker(s)

Tris  Nockles

Electronic Product Information Topic Group Highlights

Tris Nockles

Navitas Life Sciences , United Kingdom

Labeling Nets Lead

David Sidney Ross, MBA, MSc, PMP, RAC

Global Submissions Operations Topic Group Highlights

David Sidney Ross, MBA, MSc, PMP, RAC

AstraZeneca, United States

Senior Director, Regulatory Data and Submissions

Cesar  Vinces

Digitalization in Regulatory Topic Group Highlights

Cesar Vinces

Accumulus Synergy, United States

Sr. Director Regulatory Innovation & International Policy

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