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Xtalks, online
2023 -5-10
As decentralized clinical trials are becoming mainstream, there is a need for a standard regulated framework to structure digital health technologies (DHTs) for clinical investigations. Healthcare and regulatory authorities are endeavoring to provide a digital standard for conventional use by both academic and industry clinical research centers by issuing new directive guidelines.
This webinar is intended to provide the best digital health tool practices as expected by the current thinking of the US Food and Drug Administration (FDA). To achieve adequate validation of digital health technologies, stakeholders should ensure that the technologies utilized are sufficient to support their use, function and interpretability. Factors in this validation include evaluating the clinical investigation population, design and operation of the intended digital health technology and ability to allow the use of a study participant’s own digital health technology.
The featured speaker will highlight how digital health technology items should be presented in a submission. Useful directives for validation and practicality will be outlined as well as how to evaluate clinical endpoints in the context of digital health technologies and how to proceed if a novel clinical endpoint arises when leveraging these technologies.
Digital practices should adequately measure privacy-related risks. Therefore, a primer featuring key items to examine within an Informed Consent document, that leverages digital health technologies, will also be examined. Aspects of record protection and retention, as well as sponsor’s and primary investigator’s roles and responsibilities will also be reviewed.
Register for this webinar to ensure the appropriate evaluation, inclusion and presentation of all key digital health technologies in decentralized clinical trials when submitting the next Investigational Drug Application to the FDA.
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Organized by:
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Xtalks |
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Invited Speakers:
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Jorge M. Rivas, MD, PhD, Director of Regulatory Affairs, US, Amador Bioscience
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Deadline for Abstracts:
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2023 -5-10
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Registration:
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Free registration
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E-mail:
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ajuurinen@xtalks.com
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