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Medical Devices & Combination Products

Around the world, the healthcare sector is facing various challenges, as the increase of chronical diseases, aging population, lack of healthcare personnel, etc. Part of the solution to overcome these challenges are new and innovative treatments. As innovation is speeding up and technologies converge, many treatments rely increasingly on products which are working together to achieve an enhanced patient experience. Consequently, the regulatory framework which has historically been focused on individual product types (Medical Devices and Medicinal Products) needs to become more holistic to foster innovation and overcome the challenges.

Who is This Track Designed For?

This track and associated sessions are designed for health authorities and all professionals involved, interested or curious about Medical Devices and Combination Products.

Topic Leaders

Tim Chesworth

Tim Chesworth

Senior Director Regulatory Affairs

AstraZeneca, United Kingdom

Thomas Mller

Thomas Wejs Møller

Director Global Regulatory Affairs - Devices

Novo Nordisk, Denmark

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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