Catalog Advanced Search

Search by Categories
Search by Format
Search by Date Range
Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
Start
End
Search by Keyword
Sort By
  • Roadmap of the Pathways for Combination Medical Products

    Contains 1 Component(s)

    Speakers: Veronica Sansing-Foster, PhD, MS | Epidemiologist, FDA Patricia M. Giordano, DO, Merck John "Barr" Weiner, JD, FDA

    Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. The roles of each component can result in varying regulatory procedures and research methods for the combined products. This webinar will bridge the gap between the pathways taken for combination products, including companion diagnostics, which are evaluated as drugs, medical devices, or both.
    The objective of the webinar to explore the medical device and drug pathways for combination products. Participants will be able to:
    • Identify combinations products and companion in vitro diagnostics
    • Understand the varying regulatory pathways for combination products
    • Evaluate real examples of research methods used to evaluate the safety and effectiveness of combination products

  • AfRIG: Pharmacoepidemiology Study Designs

    Contains 1 Component(s)

    Speakers: K. Arnold Chan, MD, ScD, FISPE

    Dr. Chan is a physician epidemiologist with more than 30 years of global research experience in academia and private sector, with a primary focus on post-marketing evaluation of medical products. He received medical training at National Taiwan University (MD-equivalent, 1987) and advanced training in epidemiology at Harvard School of Public Health (Doctor of Science, 1992). He has served on the faculty at National Taiwan University (NTU) and Harvard School of Public Health and joined the private industry in 2005, subsequently became Chief Scientist of the Epidemiology Unit at Optum.

    Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center and Director of the Clinical Trial Center at NTU Hospital. From mid-2016 through mid-2019 he served as the Director of the Medical Research Department at NTU Hospital. In addition to scientific research, he has provided consultation for Taiwan Food and Drug Administration and related health authority for more than 20 years. Dr. Chan has been a Fellow of the International Society for Pharmacoepidemiology since 2003 and has authored or co-authored more than 140 peer-reviewed articles and co-edited a textbook on pharmacoepidemiology. According to Google Scholar, his H-index is 58 as of July 2020.

  • AfRIG: Introduction to Pharmacoepidemiology

    Contains 1 Component(s)

    Speakers: Dr. Stan Edlavitch

    Dr. Stan Edlavitch is a Professor of epidemiology (retired) in the Department of Psychiatry at the UMKC School of Medicine. He is also an adjunct professor of infectious disease at the University of Kansas Medical Center. Dr. Edlavitch served as graduate training director for the Department of Informatic Medicine and Personalized Health from 2006 to 2008 at UMKC.

  • Real-World Evidence to Assess Medical Devices: Advances through the National Evaluation System for health Technology (NEST)

    Contains 2 Component(s)

    Speakers: Daniel Canos Paul Coplan Robbert Zusterzeel Danica Marinac-Dabic Joseph Drozda Moderated by: Shumin Zhang

    Real-World Evidence to Assess Medical Devices: Advances through the National Evaluation System for health Technology (NEST)

    Background: The Food and Drug Administration funded the Medical Device Innovation Consortium to create the National Evaluation System for health Technology (NEST). The mission of the NEST Coordinating Center (NESTcc) is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research. NEST has created a Data Network with over 13 Data Partners.

    Objectives: To provide an overview of the NEST initiative, the NESTcc’s role in facilitating the timely, reliable and cost-effective development of high-quality RWE, the NESTcc test cases and demonstration projects, and their values from the perspectives of regulators, health systems, and industry. Anyone who is interested in learning the latest regulatory initiative in RWE innovation would benefit by attending.
    Description: This 90-minute symposium will bring together leaders representing key stakeholders across the medical device ecosystem involved in NESTcc programs. 
    Moderators:
    Shumin Zhang, MD, ScD, Director Regulatory RWE & Epidemiology at Johnson & Johnson
    Panelist presentations (12 minutes each):
    • Daniel Caños, PhD will discuss considerations for the use of RWE for regulatory decisions for medical devices and how NEST supplements this. Dr Caños is Acting Director, Office of Clinical Evidence and Analysis at the FDA Center for Devices and Radiologic Health
    • Robbert Zusterzeel, MD, PhD, will describe the network of research collaborators created by NESTcc, the test cases selected for funding by NESTcc, and the process for allocating funds for research. Dr Zusterzeel is a Director at the NEST Coordinating Center.
    • Joseph Drozda, MD, will describe the experience of a healthcare system in implementing NESTcc test cases using their electronic medical record and supply chain databases and lessons learned about data quality and suitability to address research questions.  Dr Drozda is the Director of Outcomes Research at Mercy Health, St Louis, Missouri.
    • Danica Marinac-Dabic, MD, PhD, FISPE, will present how the MDEpiNet, which is a public-private partnership of coordinated registry networks led by the FDA, is coordinating with the NEST initiative for using registry data.  Dr Marinac-Dabic is Associate Director, Office of Clinical Evidence and Analysis, at the FDA Center for Devices and Radiologic Health
    • Paul Coplan, ScD, MBA, FISPE, will present examples of how the NEST test cases are being used to enhance safety surveillance of medical devices and assess whether comparative safety and effectiveness studies using electronic medical record data can be used  for label extensions of medical devices.  Dr Coplan is VP and head of Medical Device Epidemiology & Real World Data Sciences at Johnson & Johnson.

  • Pragmatic Approaches From Implementation Science to Improve Risk Management Programs

    Contains 1 Component(s)

    Speaker: Meredith Y. Smith, Global Risk Management Officer, Alexion Speaker: Elaine Morrato, Dean, Parkinson School of Health Sciences and Public Health,Loyola University, Chicago

    Risk minimization programs are intended to support the benefit-risk balance of medicinal products, and recent regulatory
    guidance requires that they be evaluated for effectiveness. Implementation Science is the study of methods that influence the
    integration of evidence into practice, using social science theory and frameworks. Implementation Science can inform the
    design and implementation of risk minimization programs to ensure that they are effectively disseminated across a range of
    settings and patient populations. As a result, programs are more likely to achieve their goals for safe and appropriate use of
    medicinal products while minimizing burden on the healthcare system. This presentation will address the design,
    implementation and evaluation of risk minimization programs.

    Goal: To present concepts from implementation science and state-of-the-art pragmatic approaches to improve risk
    minimization program design and implementation. Objectives: 1) To recognize basic concepts and terms from Implementation
    Science; 2) To examine how to pragmatically apply these concepts in program design, implementation and evaluation; 3) To
    understand where to find key Implementation Science resources for further learning.

  • Open Science for Observational Research: Lessons from the OHDSI Collaborative

    Contains 1 Component(s)

    Speakers: Patrick Ryan, PhD is Vice President, Observational Health Data Analytics at Janssen Research and Development

    Observational Health Data Sciences and Informatics (OHDSI; http://ohdsi.org) is an open science community of researchers and international data network that aims to improve health by empowering a community to collaboratively generate the evidence that promotes better health decisions and better care. OHDSI conducts methodological research, develops open-source analytics tools, and applies scientific best practices to the design and execution of observational network analyses. This webinar will provide an overview of OHDSI and demonstrate how the research community has collaborated to generate real-world evidence to support clinical characterization, population-level effect estimation, and patient-level prediction.

  • Addressing missing data in comparative effectiveness research based on electronic health records

    Contains 1 Component(s)

    Speakers: Irene Petersen, Professor, UCL, Primary Care & Population Health Sebastien Haneuse, PhD, Harvard T.H. Chan School of Public Health

    Electronic health records (EHR) have been increasingly used for comparative effectiveness research (CER) because it contains rich clinical information that is not typically available in other secondary data sources. However, missing data is a common limitation when using EHR for CER. Much key information, such as laboratory results, imaging data, smoking status, or body mass index, is missing not completely at random. Therefore, advanced statistical methods often need to be implemented to ensure study validity. We aim to discuss key considerations and specific statistical methods to address missing data in CER based on EHR in North America and Europe.

    In this webinar you will learn:
    1. To discuss key considerations when designing and implementing comparative effectiveness research (CER) based on electronic health records (EHR) with missing data
    2. To discuss statistical solutions for optimal validity of CER based on EHR with missing data

  • Pharmacoepidemiology of Drugs of Abuse

    Contains 1 Component(s)

    Speaker: Judy Staffa, PhD, RPh, FDA/CDER/OSE Epidemiologists at FDA have authored the first chapter ever on the “Pharmacoepidemiology of Drugs of Abuse” in the new edition of Brian Strom’s Pharmacoepidemiology text book. This webinar will contain an overview of how different abuse is than any other drug safety issue, with examples to illustrate the different types of data and methods needed to study it.

    Speaker: Judy Staffa, PhD, RPh, FDA/CDER/OSE

    Epidemiologists at FDA have authored the first chapter ever on the “Pharmacoepidemiology of Drugs of Abuse” in the new edition of Brian Strom’s Pharmacoepidemiology text book. This webinar will contain an overview of how different abuse is than any other drug safety issue, with examples to illustrate the different types of data and methods needed to study it.

  • ISPE Journal Club Webinar

    Contains 1 Component(s)

    Join us for the first every ISPE Journal Club Webinar! Jesper Hallas and Caroline Walsh will be leading the discussion on "Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from Denmark." Jesper Hallas, Professor, consultant, DrMedSc, University of Southern Denmark will provide a brief overview of the paper and then lead a discussion.

    Speaker: Jesper Hallas, Professor, consultant, DrMedSc, University of Southern Denmark

    Join us for the first every ISPE Journal Club Webinar! Jesper Hallas and Caroline Walsh will be leading the discussion on "Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from Denmark." 
    Jesper Hallas, Professor, consultant, DrMedSc, University of Southern Denmark will provide a brief overview of the paper and then lead a discussion.

  • Targeted Learning for Estimating Causal Effects in Observational and Randomized Studies

    Contains 1 Component(s)

    Targeted Learning offers a principled statistical approach to answering questions about health and safety from data. The targeted learning framework combines two state of the art methodologies, super learning (SL) for data adaptive machine learning, and targeted minimum loss-based estimation (TMLE) for efficient semi-parametric estimation. The presentation introduces the Targeted Learning estimation roadmap, and describes TMLE and Super Learning for estimating causal effects.

    Speaker: Susan Gruber, PhD, Sr. Director of IMEDS Methods Research,Reagan-Udall Foundation for the Food & Drug Admin 

    Targeted Learning offers a principled statistical approach to answering questions about health and safety from data. The targeted learning framework combines two state of the art methodologies, super learning (SL) for data adaptive machine learning, and targeted minimum loss-based estimation (TMLE) for efficient semi-parametric estimation.  The presentation introduces the Targeted Learning estimation roadmap, and describes TMLE and Super Learning for estimating causal effects.