Training Webinar: Real-World data, Machine learning and Deep analytics in rare diseases: Regulatory grade data collection for marketing authorization submissions – what is buzz, what is realistic?

Marc Van Dijk (UCB) and Luis Pinheiro (EMA) will present views of industry and regulators on various facets of collecting, processing, and using data for research, regulatory and healthcare decisions. The two keynote talks will provide an overview of patient needs and challenges in rare disease R&D and of data and technologies that offer solutions to those challenges.

The panel discussion between representatives of patients, academia, regulatory scientists, industry and clinicians and with the audience will provide different perspectives on challenges and solutions in the context of regulatory realities and imperatives. They will also provide examples of solutions already used and their limitations.

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