Webinar: Unlocking the Potential of IDMP: Global Strategies for Enhanced Pharmacovigilance and Data Management

Abstract:

Join us for an insightful webinar that delves into the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards, a pivotal initiative reshaping global pharmacovigilance and healthcare interoperability. This session will cover the comprehensive use cases of IDMP, highlighting its crucial role in enhancing data analysis, ensuring medication safety, and facilitating efficient cross-border healthcare. We will explore key discussion points from the recent UNICOM conference, including the necessity of harmonizing clinical practices, the integration of medical devices and pharmaceutical data management, and the strategic importance of a unified European health data space. Attendees will gain a deep understanding of the challenges and advancements in implementing IDMP standards globally, the varied implications for regulatory agencies, healthcare providers, and the pharmaceutical industry. The webinar will conclude with a strong call to action, urging stakeholders to engage with the outlined action items such as adopting IDMP standards in national systems, enhancing data sharing protocols, and participating in collaborative events to test and improve IDMP compliance and interoperability. Don't miss this opportunity to be at the forefront of transforming healthcare standards and practices.

In our forthcoming webinar, we are privileged to host a distinguished panel of experts who will provide in-depth insights into the ISO Identification of Medicinal Products (IDMP) standards. Dr. Robert Stegwee will set the stage by discussing IDMP, its integration with UNICOM, and the collaboration among stakeholders. Dr. Stegwee, with decades of experience in health IT and healthcare interoperability standards, serves as a bridge between technological advancements and healthcare efficiencies. Dr. Robert Vander Stichele will then explore clinical and pharmacovigilance use cases of IDMP, drawing on his vast background as a clinical pharmacologist and his research in pharmaco-epidemiology. Dr. Ron Fitzmartin will expand on additional use cases and share regulatory perspectives from the FDA, 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, the webinar promises a comprehensive overview of IDMP's application and its transformative potential in healthcare. This expertly guided discussion will not only deepen your understanding of IDMP but also highlight actionable steps towards its implementation.

Panelists

Dr. Ron Fitzmartin serves as a Senior Advisor in the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). In this capacity, Dr. Fitzmartin contributes to the development and implementation of strategy and guidance related to electronic submissions and standardized data in support of the regulatory review of medical products. In addition, Dr. Fitzmartin has led the FDA’s policy to implement the ISO Identification of Medicinal Products (IDMP) for global use for post market pharmacovigilance, drug shortage and cross-border healthcare. Dr. Fitzmartin, along with Dr. Malin Fladvad (WHO/UMC), chartered the Global IDMP Working Group in 2021 to focus on the development of global identifiers. In addition to global IDMP standards, Ron is Rapporteur of the ICH M11 Clinical electronic Structured Harmonized Protocol Expert Working Group with a goal to have an endorsed Clinical Protocol Guideline, Template, and Technical Specification in 2025.

Prior to FDA, Dr. Fitzmartin held roles as the VP of Informatics & Knowledge Management at Daiichi Sankyo, Inc., VP of Biostatistics, Data Management and Informatics at Daiichi Medical Research, Inc., and Group Executive Director of Biostatistics & Clinical Operations at Purdue Pharma.

Over many years Dr. Fitzmartin has been a regular speaker, session chair, and meeting chair at numerous professional meetings. In 2006, Ron was elected DIA’s President-elect and served as President in 2007-2008. During Dr. Fitzmartin’ s tenure as President, DIA established offices in India and China.

Dr. Fitzmartin received a PhD in Statistics from the University of Maryland and an MBA from the University of New Haven.
LinkedIn: https://www.linkedin.com/in/ronfitzmartin

Dr. Robert Stegwee is a consultant for Health Informatics, based in the Netherlands. He is passionate about meHealth: improving the healthcare experience from a healthcare consumer and professional perspective. He has been involved in healthcare IT in different capacities since 1993, starting in a hospital environment and consulting in different sectors of healthcare, including at a national and international level.

Dr. Stegwee received his Master's degree in Computer Science from the University of Amsterdam in 1986 and a PhD in Management and Organization from the University of Groningen in 1992. This prepared him for a combined academic and practical career in the field of information management. He believes that aligning the technological achievements with the organizational dynamics within healthcare is an especially rewarding challenge, as improving the efficiency and effectiveness of healthcare benefits us all. His work in healthcare has focused on the use of high level architectures to achieve an evolving integrated health information environment.

Healthcare interoperability standards form a topic that is at the heart of effective multivendor architectures as appropriate in healthcare. Dr. Stegwee has participated in the development of the Health Level 7 standards and currently serves as member of the board of HL7 The Netherlands, member of the board of HL7 Europe, chair of CEN/TC 251 on Health Informatics, and member of Joint Initiative Council on Global Health Informatics Standardization. His current project involvement includes UNICOM, XpanDH and xShare, all financed by the European Union but all with an outlook to the adoption and use of international standards.

Dr. Stegwee has co-authored a large number of both scientific and professional publications, including a book on Strategies for Healthcare Information Systems and a chapter on Standards in Healthcare Data. As a professor at the University of Twente, he has supervised numerous MSc and PhD projects, some of them directly related to standards in healthcare.

Dr. Stegwee's specialties include: Semantic and Pragmatic Interoperability, Healthcare Information Exchanges, Information Strategy, Information Architecture, Electronic Health Records, Personal Health Records, eHealth, and meHealth.

LinkedIn: https://www.linkedin.com/in/stegwee/

Dr. Robert Vander Stichele is a certified clinical pharmacologist, and pharmaco-epidemiological researcher.

He retired as a family physician in Ghent, Belgium in 2019, after 41 years of clinical practice, combined with research projects, since 1982. He obtained his PhD (in medical sciences) in 2004, and was appointed as teaching professor in the department of Pharmacology in the University of Ghent. He became a certified clinical pharmacologist in 2009.

Dr. Vander Stichele's interests are on information on and use of medicines. He is member of the Special Interest Group on Drug Utilization in the International Society for Pharmaco-epidemiology (ISPE). He is a senior-researcher in the research alliance on “End-of-Life Care”, a consortium of the University of Ghent, Brussels, Amsterdam and Rotterdam.

Dr. Vander Stichele is a member of the Board of the International Society of Phthirapterists (ISOP), and of the European Society for the study of Patient Adherence and Compliance (ESPACOMP). He is founding member of the Board of the Belgian Centre for Evidence-Based -Medicine (CEBAM). Currently, he works as an expert in European projects for the European Institute for Innovation through Health Data (I-HD), and in the spinoff Ramit of the Department of Medical Informatics of the University of Ghent. He has been appointed as work package leader for the UNICOM project on Identification of Medicinal Products, working on applications of the new ISO IDMP standards to clinical practice and medical clinical research.

His publication list comprises more than 200 scientific papers (referenced in PubMed, Mendeley and Web of Science).

LinkedIn: https://www.linkedin.com/in/robert-vander-stichele-a8668513/

Dr. Yuri Quintana is a global leader in developing and evaluating digital health systems. He is Chief of the Division of Clinical Informatics at Beth Israel Lahey Health and Assistant Professor of Medicine at Harvard Medical School, Harvard University. His research is focused on learning networks and clinical care collaboration platforms that empower patients, families, and health professionals. He leads the DCI Network (https://www.dcinetwork.org), which brings together national-level leaders to work on complex health problems requiring collaborations between institutions, government, and the private sector. He is developing InfoSAGE, a mobile app for home-based coordination (https://infosagehealth.org) for medication and symptom management. He created Alicanto Cloud (https://www.alicantocloud.com), an online platform for learning and collaboration used by health professionals at Harvard-affiliated hospitals such as Beth Israel Deaconess Medical Cancer to disseminate best healthcare practices and virtual consultations. Alicanto is used at the Massachusetts Institute of Technology’s JWEL Center for sharing best practices in education. As a Senior Scientist at Homewood Research Institute in Canada, he has developed new methods to evaluate digital mental health systems using evidence-based approaches. Previously, at St. Jude Children’s Research Hospital, he developed Cure4Kids, a global pediatric cancer learning network used by thousands of health professionals, POND4Kids, an international cancer registry, and Cure4Kids for Kids, a mobile app promoting healthy lifestyles for children. Quintana was a principal investigator in the Canadian HealNet Research Network. He has held high-tech positions at IBM and Watcom. Dr. Quintana obtained his engineering degrees from the University of Waterloo in Electrical and Computer Engineering and Systems Design Engineering. More at http://www.yuriquintana.com and on Twitter at @yuriquintana.

LinkedIn: https://www.linkedin.com/in/yuriquintana/

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 that includes 18 European countries and the United States, either as beneficiaries or as 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. Border electronic prescription services; improve patient safety and better medical care. At the same time, it will benefit pharmaceutical companies applying for marketing authorization for new products, providers of drug dictionaries or databases, clinical software companies, including startups developing smart applications for patients, and finally , to patients and health professionals. The UNICOM consortium includes 26 national drug and eHealth agencies, standards development organizations (SDOs), cross-border e-prescription service providers in the context of the EU Connecting Europe Facility (CEF) eHealth services, physicians, software providers, producers of pharmaceutical dictionaries and others. A wide variety of relevant stakeholders are involved through their associations. 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 discussion of high-impact biomedical discoveries leading to healthcare delivery improvement. Learn more at https://www.dcinetwork.org

The Division of Clinical Informatics, created in 1970 by Dr. Howard Bleich and Dr. Warner Slack, was among the first academic divisions in the world to concentrate on the use of computers for patient care, teaching, and medical research. The goals of the Division have been to improve the relationship between doctor and patient, enhance medical education, improve quality, and reduce costs.. Current research includes the design and evaluation of clinical information systems, translational research platforms, patient portals, and patient engagement, quality improvement processes and analytics, clinical decision support systems, online learning systems, mobile health applications, global e-health applications. The Division hosts a variety of a wide range of training programs, from internships to fellowships, to international industrial programs. If you are a US physician, read more about fellowship program at Clinical Informatics Training Program Att Beth Israel Deaconess Medical Center. Learn more at https://research.bidmc.org/dci