戻る Agenda
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