25 September 2024 - Standards in Sync: Accelerating Medical Research

Webinar Topic

Standards in Sync: Accelerating Medical Research

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Webinar Date & Time

25 September 2024 from 4:00PM to 5:30PM (CEST)


Webinar Overview

It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the purpose and how to ensure they are robust and will achieve the desired goals. All too often in the standards development world, we are faced with competing standards, new ‘standards’ development when standards already exist, or mapping data into a standard after the study has ended. These redundancies and inefficient methods incur costs in terms of resources, money and, in some cases, risks to patients (i.e. all of us). They may also have a negative effect on the data. This workshop is the first of a series of 3 and is organized in the context of xShare, a three-year Horizon Europe project that envisions expanding the European Electronic Health Record exchange Format (EEHRxF) to improve interoperability within the European Health Data Space (EHDS). It is the hope that these new interoperability capabilities and this collaborative work will enable a greater alignment of data quality between care and research, to transform data into valuable knowledge with benefits for all. We will cover the research use cases that are the focus of xSHARE and the standards that are being employed in a synchronized manner.

Attendees of this webinar will learn:
a) Overview of the EU xSHARE project
b) Rationale and benefits of using standards in the planning stage of clinical research studies
c) Characteristics of robust standards and achieving semantic interoperability at the source
d) Examples of complementary implementation of standards, including xSHARE
e) Five principles of developing and implementing synchronous standards



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Presenters

Rhonda Facile ​

VP, Partnerships and Development

CDISC


Rhonda Facile is currently VP, Partnerships and Development at CDISC where she oversees strategy and new project development. Rhonda has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies in the United States and abroad.  She has experience in clinical trial monitoring, program management, regulatory affairs and standards development.

At CDISC, Rhonda brings together, key and diverse stakeholder communities, including the clinical community, global regulatory authorities, national health agencies, global biopharmaceutical and vendor organizations to forward clinical informatics and the use of CDISC standards.  Rhonda represents CDISC at ISO TC215, the HL7 Accelerator Vulcan Operations Committee and at numerous other collaborative organizations and partnerships.

Ms. Facile holds an MS from St. Edwards University and a BA from the University of Texas at Austin. 

Rhonda has instantiated the body of peer-reviewed articles on CDISC standards implementation published in the Journal of the Society of Clinical Data Management (SCDM) and has authored and co-authored publications that are published in journals such as Journal of Medical Internet Research (JMIR) and Drug Discovery, and in several meeting proceedings.  Rhonda also contributed to chapters in the textbook Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Documentation 1.1, Cambridge and Boston, MS: Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), published in 2021.

  


Rebecca Daniels ​Kush

Founder and President Emeritus

CDISC


Rebecca Daniels Kush is currently President of Catalysis and Founder and President Emeritus of the Clinical Data Interchange Standards Consortium (CDISC). She is on the Board of the Learning Health Community; serves as an Associate Editor of the Learning Health Systems Journal (Wiley); and, chairs the Advisory Council for the Vulcan HL7 FHIR Accelerator.

Dr. Kush served for 20 years as President and CEO of CDISC, which was formed as a volunteer group in 1997 and was incorporated as a 501c3 non-profit standards development organization (SDO) in 2000. CDISC Europe Foundation was founded in 2011, enabling participation in IMI and EU collaborations.  CDISC has developed and harmonized a suite of global clinical research data standards to support clinical research in therapeutic areas that affect well over 1.5 billion lives. These standards are required for the submission of data to support regulatory reviews and approvals of new products by the U.S. FDA and Japan’s PMDA and are endorsed by other regulatory agencies (EU, Korea and China).

Dr. Kush retired from the leadership position at CDISC in 2017 and spent six years as Chief Scientific Officer for Elligo Health Research, a start-up in Austin, TX focused on expanding research opportunities to community clinicians and leveraging healthcare data for research.  She participated in two FDA grants associated with the harmonization of common data models and identifying academic data partners to test use cases for these projects.

Prior to founding CDISC, Dr. Kush worked with the U.S. National Institutes of Health (NIADDK center at the Indian Medical Center in Phoenix, Arizona); a global clinical research organization (CRO); and biopharmaceutical companies headquartered in the U.S. and Japan. She served for five years on the U.S. Federal Health IT Standards Committee (HITSC), three years on the DIA Board, four years on the HL7 Board and was also on boards for ACRES, Litmus Health and Saama (an AI/technology company).

Dr. Kush earned her doctorate in Physiology and Pharmacology from the University of California San Diego School of Medicine and a B.S. in Biology and Chemistry with honors from the University of New Mexico.

She has authored publications that are published in journals such as New England Journal of Medicine, British Medical Journal, Science Translational Medicine, International Clinical Trials, Journal of Biomedical Informatics, DIA Journal, Applied Clinical Trials, and the Learning Health Systems Journal. She edited and authored chapters for a CenterWatch book on eClinical Trials and authored chapters for three editions of the Springer Clinical Research Informatics textbook, the latest released in 2023.


Panel

Professor Dipak Kalra

President of The European Institute for Innovation

through Health Data (www.i-hd.eu)


He is a Professor of Health Informatics and a former London general practitioner. He plays a leading international role in Electronic Health Record R&D, including the reuse of EHRs for research. He has led the development of ISO standards on EHR interoperability, personal health records and data protection. He participates in multiple European Commission funded projects including the generation of real-world evidence in pregnancy, support for the accelerated uptake of digital health innovations, scaling up the quality, interoperability and the reuse of health data for research including inputs to the European Health Data Space, scaling up of the collection and use of health outcomes towards more value-based care, the development of an AI-powered federated learning platform in lung cancer and initiatives to explain the value of clinical research to the public.


Christophe Le Danec
Director Healthcare International by Infor


Christophe has been in the IT and healthcare industry for more than 20 years. He specializes in making companies profitable from the ground up by applying a unique blend of business acumen, interpersonal skills and technical knowledge. With his experience in developing business models and implementing innovative digital solutions, he has already established many successes in Europe.


Abdelkrim Boureche
 Solution Architect at Infor


Abdelkrim has more than 15 years of experience in enterprise solution implementation and pre-sales engineering. He has a passion for data/application integration and process automation.

Hands-on experience with hybrid integration solutions ESB, EAI, iPaas, middleware, integration architecture patterns, web service technologies, APIs, SOA, BPM, databases

Customer oriented and familiar with analyzing requirements, creating PoC/PoV, conducting technical and architecture workshops, demonstrating solutions and presenting at technical and C-level.

Catherine Chronaki

 Secretary General HL7 Foundation


Catherine Chronaki is a computer engineer, Secretary General HL7 Foundation. Catherine has played a key role within National and European digital health projects. Author of 100+ research papers, she has served as Associate Editor IEEE TITB, and on committes major eHealth conferences. Catherine served on the Board of the European Federation for Medical Informatics-EFMI (2014-2024), as EFMI president (2020-2022), the HL7 International Board of Directors (2008-2012, 2023), the eCardiology WG, European Society of Cardiology (2012-2015), and the eHealth Stakeholders group of the European Commission (2013-2026). She is the interoperability lead of the Gravitate-Health project (2019-2026) and the scientific coordinator of the xShare project (2024-2026) inspired by digital health services that bridge to public health and clinical research while making sense for patients and health-conscious individuals.


Attendance Fee

The participation in this webinar is free of charge.


Deadline for registration

24 September 2024 at 6:00PM


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