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CMC and Product Quality

The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides insights into current trends in technical development, manufacturing, CMC regulatory submissions and GMP inspections. Sessions will cover CMC regulatory and quality aspects related to innovation in therapies and technologies, early patient access, the digital future of facilities and CMC submissions, global regulatory harmonization and the impact on CMC/GMP of recent non-pharma legislative developments.

Who is This Track Designed For?

This track is designed for professionals who want to keep up to date with most recent developments in science, technology and regulations impacting CMC/GMP related activities.

DIA Europe 2023 - Searchable Programme

The online program is now available. Explore the rich content we offer across 10 thought leadership tracks. 

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Topic Leaders

Ursula Busse


Global Head of Quality Intelligence & External Affairs

Boehringer Ingelheim, Germany

Markus Goese

Markus Goese

Head EU CMC Regulatory Policy

F. Hoffmann-La Roche Ltd., Switzerland

DIA Europe 2023 Highlights

It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.

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