Speaker’s Corner: DIA European eDM Conference

Peter Lassoff, Vice President and Head, Global Regulatory Affairs, and Joel Finkle, Associate Director Offering Management for Regulatory Innovation will both be speaking at the Drug Information Association’s eDM 2018 – Clinical and Regulatory Operational Excellence Forum 29-30 November in Barcelona, Spain.

They will coincidentally be presenting in the same session, Process Automation, chaired by Dimitri Stamatiadis. This came as a bit of a surprise to the presenters and conference-runners, but resulted from abstract submissions happening before ACUTA joined IQVIA.

Peter’s presentation is titled “Transforming Regulatory Affairs through Technology – End to End Tech Platform Approach” and will be describing how an end-to-end RIM system that incorporates the needs of multiple disciplines can streamline the activities of regulatory affairs and operations.

Joel’s presentation is titled “All the Way Around the RIM: From Registration Data to Documents to Dossiers and Back.” This is a look back at how component-based authoring has failed to capture the content creation world, and what can be done to build toward it using Word Processing technologies instead of custom XML, while leveraging the data in Content Management, Submission Publishing and Regulatory Information Management systems.

IQVIA will also have a table in the exhibition area of the conference.

The eDM conference is named for Electronic Document Management (not electronic dance music – hopefully that doesn’t disappoint), and will bring together leading experts and problem-solvers in the field to discuss proven working solutions and best practices in dealing with innovative technologies and changing regulations. This includes topics in artificial intelligence and machine learning, risk and compliance, data integrity, information governance and document flow and interoperability.

We hope you can join us there in Barcelona, perhaps share some cava and jamón iberico, and exchange ideas. Look here after the conference for the presentation materials, and after what you learn there, contact us about how RIM+ and IQVIA services can help you with your regulatory processes.

[edited December 12, 2018] As promised, here are the presentations:

Soapbox image credit: “Daretoeatapeach

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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