DIA EUROPE 2020

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Telematics Strategy in the EU: Global and Regional Considerations for 2020-2025

Session Chair(s)

Bernd Misselwitz, PhD

Sr. Director, Regulatory Submission Management

Bayer AG, Germany

Vada Perkins, DrSc, MSc

Vice President, Global Head of Regulatory Intelligence & Policy

Boehringer Ingelheim, United States

Regulatory operations are not immune to advancements in emerging technology as traditional submission processes will be disrupted by data standards and cloud technology. This session will explore opportunities and challenges of tech and innovation.

Learning Objective : Distinguish between the different dossier and submission formats and standards Recognize evolutionary trends and developments in Regulatory Operations processes and technologies Identify the impact of … on … Adapt new innovative technologies like SPL, IDMP-SPOR, CESSP into regulatory business

Speaker(s)

Telematics-Digital Transformation of Regulatory Activities: data-driven submission and assessment for qualified data for Industry and Authority use cases

Laurent Desqueper

-, Belgium

IDMP Business Data Lead

The State of EU Telematics: Opportunities/Challenges for EU Priorities and Initiatives.

Remco Munnik

IRISS Forum, Spain

President

NCA Perspective and Updates on EU Telematics and SPOR Program

Georg Neuwirther, MS, MSc

Austrian Medicines & Medical Devices Agency (AGES), Austria

IT Director

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