The webinar will be organised by UNICOM partner HARVARD MEDICAL SCHOOL and has as key objective to update the American interested audience about UNICOM results and discuss in particular some elements of divergence of major importance between the EU and the US .
We’ll explore the necessity of harmonizing clinical practices, integrating medical device and pharma data management, and the strategic importance of a unified European health data space.
Dr. Robert Stegwee will discuss IDMP’s integration with UNICOM and collaboration among stakeholders, drawing from his expertise in health IT and healthcare interoperability standards.
Dr. Robert Vander Stichele, a clinical pharmacologist, will explore the clinical and pharmacovigilance use cases of IDMP.
Dr. Ron Fitzmartin from the FDA will share regulatory perspectives, emphasizing the importance of standardized data in regulatory reviews.
Moderated by Dr. Yuri Quintana, a leader in developing digital health systems for enhanced clinical care.
Who Should Attend?
Regulatory agencies, healthcare providers, the pharmaceutical industry, and anyone interested in transforming healthcare standards and practices.
Key Takeaways:
1. Deep understanding of IDMP implementation challenges & advancements globally
2. Varied implications for regulatory bodies, providers & pharma industry
Actionable steps: Adopt IDMP in national systems, enhance data sharing, participate in collaborative IDMP testing & improvement
ABOUT UNICOM
The UNICOM project is financed by the European Commission within the framework of the Research and Innovation Program “Horizon 2020”, this action has a budget of 21 million euros, with an EC funding of 19 million euros. The consortium is composed of 70 organizations, including 18 European countries and the United States, who are either beneficiaries or observers. UNICOM will focus on the development of the IDMP set of standards (Identification of medicinal and pharmaceutical products) of the International Organization for Standardization (ISO), its testing, implementation, and dissemination for regulatory purposes by the National Pharmaceutical Agencies for global pharmacovigilance and for the advancement of European cross-border dispensing. Learn more at https://unicom-project.eu
ABOUT DCI NETWORK
The DCI Network brings together top thought leaders and decision-makers from the private sector, government, non-profits, and academia to discuss emerging opportunities in digital health, accelerate innovation and generate value from health data. The Network will create a consortium to develop roadmaps for aggregating large amounts of healthcare data from disparate stakeholders to accelerate the discussion of high-impact biomedical discoveries leading to healthcare delivery improvement. Learn more at https://www.dcinetwork.org
The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.
🗓️ Wed, 05/22/2024 – 12:00 – 13:30 EST (18:00-19:30 CEST)