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Tuesday, June 25 • 4:15pm - 5:30pm
#296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-645-L04-P; CME 1.25; IACET 1.25; RN 1.25

The evolution of actionable insights on how medicines are used, generated from real world evidence and artificial intelligence will be discussed. This session will focus on knowledge management, regulatory intelligence, and learning healthcare systems.

Learning Objectives

Discuss the potential for artifical intelligence and real world evidence to inform both development and authorization; Identify the opportunities and barriers and how AI and RWE in conjunction with knowledge management can enable better development and regulatory decisions.


Lawrence Eugene Liberti, PhD, RPh, RAC


How Do Companies View Knowledge Management as a Decision-Making Tool?
Magda Bujar, PhD, MSc

Learning Healthcare Systems: Managing Real World Evidence/Knowledge - How Can This Transition Healthcare Data to Actionable Information?
Andrea Julsing Keyter, MS

Potential Uses of AI for Regulatory Intelligence: How Can This be Used Practically and What are the Barriers and Opportunities?
Mukesh Singhal, MBA

avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre For Innovation In Regulatory Science (CIRS)
Dr Magda Bujar is the Manager of Strategic Development at CIRS. In her current role, she is responsible for developing and executing strategies for engaging with CIRS stakeholders - pharmaceutical companies as well as major regulatory authorities. Magda also initiates and coordinates... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Andrea Keyter

Andrea Keyter

Deputy Director, Medical Devices, South African Health Products Regulatory Authority
Andrea is a pharmacist and has 10 years of experience within the field of regulatory affairs, quality assurance, quality risk management, pharmaceutical production, complementary medicines manufacture and risk-based inspection planning. In her current role, Andrea is responsible for... Read More →
avatar for Mukesh Singhal

Mukesh Singhal

Senior Manager, Deloitte
Mukesh is a Senior Manager in Deloitte Consulting's life science R&D practice. He has spent over 15 years of his career between industry and Consulting. He focuses on helping R&D organizations at biotech and pharmaceutical companies address strategic and operational challenges with... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA