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Unlocking Potential and Navigating Limitations of Using Real-World Evidence in Safety

Tue, Dec 12, 2023 10:00 AM EST{LOCAL_TZ} | 9:00 AM CT | 3:00 PM GMT | 4:00 PM CET


Rethink the possible. Explore trends, innovative technologies, industry collaborations, and leading-edge techniques to help you stay at the forefront of clinical research and safety solutions. Learn more about the Oracle Innovation Series

Event Overview: 

The utilization of real-world evidence (RWE) for safety assessment has become an integral component of healthcare decision-making. The panel will explore how regulatory agencies have evolved to incorporate RWE into safety evaluations and the FDA's commitment to leveraging RWE for post-market surveillance, signal detection, and decision-making in regulatory processes. The challenges inherent in the use of RWE in safety assessments – data quality, potential biases, privacy concerns, and the need for robust methodologies will be discussed.

The importance of technology in enabling the efficient generation and utilization of RWE for safety – including AI and platforms that facilitate data integration, analytics, and decision support, enabling healthcare stakeholders to harness the full potential of RWE in real-time safety monitoring will be explored. The role of collaboration and data-sharing among regulatory bodies (including the Sentinel Initiative, a national system for monitoring the safety of FDA-regulated medical products), healthcare technology providers, and pharmaceutical companies will be emphasized as crucial in ensuring that RWE contributes to safer and more effective healthcare practices – illuminating the path forward for all healthcare stakeholders.

Key Learning Objectives: 

  • Understand the collaborative efforts between regulatory bodies, healthcare technology providers, and pharmaceutical companies in advancing RWE for safety.
  • Discuss potential future directions of RWE in safety assessment, considering evolving technologies and regulatory strategies.
  • Explore the opportunities and challenges in using RWE for safety and its impact on patient outcomes.
  • Understand how RWE contributes to more informed healthcare decision-making and better patient outcomes.
  • Gain insights into how different stakeholders can use RWE to make more informed and data-driven decisions regarding the safety of medical interventions.
  • Identify best practices and key takeaways for leveraging RWE for safety assessments that can be applied in both regulatory and industry settings.
  • Understand how technology and collaboration can enhance the quality and efficiency of RWE-based safety evaluations.

Who Should Attend:

This webinar is applicable to:

Clinical researchers, data scientists, clinical decision teams responsible for:
  • Clinical development planning and study design
  • Management of patients and measurement of clinical outcomes
  • Clinical data management, collecting and evaluating trial metrics
  •  Project management of studies, process optimization, and operational excellence



For any technical questions please contact Morgan Marant:
mmarant@mjhevents.com 



DANICA MARINAC-DABIC
Associate Director, Office of Clinical Evidence and Analysis
US Food and Drug Administration (FDA)  
Center for Devices and Radiological Health (CDRH)


Danica Marinac-Dabic, MD, PhD, MMSc, FISPE serves as the Associate Director of the Office of Clinical Evidence and Analysis, at the FDA, Center for Devices and Radiological Health (CDRH). Prior to this position she was the Director of the CDRH Division of Epidemiology. Under her leadership, in 2010 FDA/CDRH launched its MDEpiNet Initiative. Dr. Marinac-Dabic also led the development of the International Consortium of Orthopedic Registries Initiative; International Consortium of Cardiac Registries and International Consortium of Vascular Registries. From 2015-2018 she led the Registry Working Group at the International Medical Device Regulators Forum to develop series of essential principles for international convergence of registry-generated data for regulatory decision making.  Since 2017, she leads the PCORTF- funded effort to establish Women’s Health Coordinated Registry Network for addressing clinical questions on devices, therapies, and their combinations for the treatment of uterine fibroids, pelvic floor disorders and female sterilization. She is a Fellow of the International Society of Pharmaco-epidemiology and Therapeutic Risk Management, Member of the Executive Operations Committee of the MDEpiNet, Member of the Steering Committee of Transcatheter Valve Therapies Registry, National Breast Implants Registry and Oxford-based IDEAL Collaborative, EXCITE International Collaborative and International Consortium of Breast Registry Activities. Prior to coming to FDA, she garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment.



RISHI J DESAI
Operations Chief for the Sentinel Innovation Center and Professor of Medicine
Harvard Medical School


Rishi J Desai, MS, PhD, is an Associate Professor of Medicine at Harvard Medical School and an Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research focuses on understanding the use of medications and resulting outcomes in routine care patients with chronic diseases. He has a special interest in methodological investigations to improve inference from non-randomized studies of medication effects. He has authored >150 original research publications. He is the Operations Chief for the FDA Sentinel Innovation Center.  His work is funded by National Institute of Aging, National Heart, Lung, and Blood Institute, and Food and Drug Administration.
 



MARTINA FUREGATO
Associate Principal
Oracle Life Sciences

Martina is an Associate Principal at Oracle Life Sciences in addition to holding an Honorary Senior Research Fellow at St George’s University of London. Her current role at Oracle Life Sciences involves the management of a team of scientists specialized in Claims and EHR studies globally. She possesses expertise in the field of epidemiology and advanced statistical analytics. Prior to this, Martina held the position of Program Manager at St George’s University of London where her primary role included the implementation of the epidemiology program related to infectious disease and antimicrobial resistance and support to diagnostic companies to enter the market with near to patient technology. Earlier positions included Senior Scientist at the UK Health Security Agency where she oversaw surveillance and outbreak detection programs and collaborated with the Centre for Disease Control (CDC) on HIV and STI prevention research and surveillance and she worked in other government funded bodies in Europe focusing on national and international research.


ROBERT WEBER
Product Management Director
Oracle Life Sciences

Robert Weber is Product Management Director at Oracle Life Sciences. His responsibilities include the Empirica signal detection and management products in the Oracle pharmacovigilance suite. Robert works with regulatory agencies, key industry partners and research organizations to provide direction and manage priorities for the Oracle safety products, define areas for enhancements and identify new solution opportunities.

He is a qualified physician with practice background in neurology. He has worked since 1995 in the area of drug development, clinical research and pharmacovigilance. Earlier positions included Senior Manager and Principal Consultant at PAREXEL International, a contract research organisation, in Berlin and London; Senior Project Manager at DocCheck Medical Services in Cologne; and Principal Consultant at Phase Forward’s Lincoln Safety Group.



ELISE BERLINER  
Global Senior Principal of Real-World Evidence Strategy
Oracle


Elise Berliner, PhD is the Global Senior Principal for Real World Evidence Strategy at Oracle Life Sciences. Before joining Cerner Enviza (acquired by Oracle in 2022), Dr. Berliner was the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ), providing systematic reviews and other scientific analyses to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions and other policy issues. Dr. Berliner has several years of experience in research and development at innovative medical technology companies, was a Fellow at the Office of Technology Assessment in the United States Congress, and received her Ph.D. in biophysics from Brandeis University.