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This session will provide an overview on the current status of the IDMP implementation in the European Economic Area with regards to agency requirements and timelines. Learn what industry has done so far to prepare and what is needed going forward.

Speaker:

Jörg Stüben
Head of Regulatory Information Management and Senior Expert
Boehringer Ingelheim International GmbH

Mature technology now gives us the potential to meet the unique challenges of label management including the processing of global information while reflecting local requirements.

We are much closer to attaining significant gains in the following areas:

• Change Impact Assessment
• Regulatory Intelligence
• Deviation Management
• Structure Authoring
• Automated Translation
• Automated Artwork generation
• Dynamic Rendering

• Learn the technology needs and future landscape for effective Label Content and Planning Management
• Gain a clear understanding of the path to effective label management and the solutions to consider integrating into their environment

Speakers:

Cham Williams
Associate Director
Business Systems
IQVIA

Julian Backhouse
Associate Director, Regulatory Technology
IQVIA

• Understanding of previous system features for the design and improvement of new/existing RIM System
• How to define the requirements of an already implemented RIM based on the balance effort/benefit
• Analysis and alignment of Vendor roadmap vs company needs
• Expanding scope of existing RIM System more than for Pharmaceutical Products (e.g. Medical Devices, Active Substance, Clinical Trials)

Speaker:

Ana Montoya Alarcon
Regulatory IT Manager
Novartis