DIA’s Impact on Data in Clinical Development

DIA’s Impact on Data in Clinical Development

Welcome to this month’s DIA In Focus newsletter.?Learn, engage, and contribute your thought leadership through DIA, and look for new In Focus newsletters on a different topic every month.

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DIA Research: Artificial Intelligence for Adverse Events Prediction

?DIA is forming a collaborative working group to explore the impact of AI on pharmacovigilance. The research aims to promote the adoption and implementation of AI in adverse event identification and signal detection in safety organizations. To learn more about this effort or other DIA Research and Think Tanks, click?here?or contact?[email protected]?to contribute.

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DIA Research: Benchmarking Data to Help Track How Organizations Engage Their Patients

?DIA and Tufts CSDD administered an assessment tool that companies can use to evaluate their organization’s patient engagement capabilities and implementation preparedness and to measure the impact of such activities on trial outcomes. To learn more about the research findings and their implications, click?here.

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How Generative AI May Transform Content Development in the Life Sciences

?Foundational large language models such as GPT-4 are significantly changing how domain subject matter expertise intersects with technology, and the life sciences industry is among the largest beneficiaries. Read more?June 2023??Global Forum?Digitization and Digitalization content below:

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Podcast: Retiring TGA Head Maps Australia’s Post Pandemic Future

?International regulatory collaboration, and exchanging information on real-world data and evidence, can continue to hasten patient access to therapeutic advances in Australia and around the world. Listen to?Podcast.

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RWD/RWE in 2023: Regulatory Policy World Tour

?To continue to deliver on the promise of its?Big Data Workplan 2022-2025, the HMA/EMA Joint Big Data Steering Group published a?list of metadata for real-world data catalogues?that describes RWD sources and studies, followed by a?Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources?as well as a call for applications on a pilot using raw data in medicine evaluation.

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Global Specialty Meetings:

Innovative Trial Designs Conference?| October 3-4, 2023

DIA’s Innovative Trial Designs Conference will bring together a truly multidisciplinary group of experts in clinical trial planning, execution, and analysis. Contribute your perspective and discuss both the common and unique challenges and opportunities for innovation to meet patients’ needs through protocol design.


Real-World Evidence (RWE) Conference?| October 16-17, 2023

DIA’s Real-World Evidence Conference will explore new, innovative applications of RWE and deliver cutting-edge insights to leverage this knowledge to advance healthcare decision-making.

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DIA Global Clinical Trial Disclosure and Data Transparency Conference | December 5-7, 2023, virtual

Learn More Here

Sessions on Clinical Data: European Health Data Space: What You Need to Know

Learn about the EU’s vision for and status of the?European Health Data Space (EHDS)?and get answers to questions such as: What are the legal issues to take into account? How will this regulation impact protection of personal data and commercially confidential information?

EU AI Act: First-Ever Regulation on Artificial Intelligence Worldwide

We expect to cover the topic at?DIA Europe 2024?and, depending on when the new regulation will be published, at the?Innovating Clinical Trials in Europe?meeting as well.

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