M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 1 Overview I.What DPS does… II.The Brick Model… III.Where.

Slides:

Advertisements

Similar presentations

Postmarket Surveillance of Medical Device Adverse Events Hesha Jani Duggirala, PhD Epidemiology Branch Division of Postmarket Surveillance Office of Surveillance.

Advertisements

The 2002 Davis Besse Event and Safety Culture Policy at the U.S. Nuclear Regulatory Commission Stephanie Morrow, Ph.D. Safety Culture Program Manager Office.

1 Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine Patrick Caubel, MD, PhD Head of Pharmacovigilance North America February 27, 2007.

Public Health Issues Related to Mutually Conforming Labeling: CDRH Perspective Miriam C. Provost, Ph.D. Office of Device Evaluation Center for Devices.

Surveillance. Definition Continuous and systematic process of collection, analysis, interpretation, and dissemination of descriptive information for monitoring.

Field Investigators: ADE Detectives. Section One Introduction to the Team and Their Roles.

Postmarketing Risk Assessment of Drug Products Division of Drug Risk Evaluation Office of Drug Safety Center for Drug Evaluation and Research.

Lecture 3 Strategic Planning for IT Projects (Chapter 7)

Total Product Life Cycle An Example. Medcon May 2, Agenda Post Market Surveillance Total Product Life Cycle and Product Design Systematic Collection.

Integrating Occupational Hygiene and Medical Programs Using Occupational Health Manager (OHM) Tom Polton Pfizer Inc.

FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public n Managing the Risks of Medical Product Use.

Adverse Event Reports on Automatic External Defibrillators from Oscar H Tovar MD and Beverly Gallauresi RN, MPH Food and Drug Administration.

FDA Resources and Meetings FDA/EMA Orphan Designation and Grant Workshop Silver Spring, Maryland FDA Campus (White Oak) October 12, 2012 Bill Sutton Deputy.

FDA Recalls Risk Communication Advisory Committee David K. Elder Director, Office of Enforcement.

DSaRM Advisory Committee May 18, 2005 Active Surveillance for Drug Safety Signals: Past, Present, and Future Mary Willy, Ph.D. Division of Drug Risk Evaluation.

 Pharmacovigilance – Patient’s standpoint Steve Arlington May 2007.

Emissions Inventory and Air Quality Planning National Urban Air Quality Workshop Lahore, Pakistan December 13, 2004.

The National Intelligence Model (NIM)

What Makes a Good Medical Device Adverse Event Report?

Office of the Federal Coordinator for Meteorological Services and Supporting Research (OFCM) Presentation for the ITS America 2006 Annual Meeting May 9,

Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT.

Top 10 Medical Device Citations

Pharmacovigilance Programme of India

Device Clinical Trials and More… Michael E. Marcarelli, PharmD Director, Division of Bioresearch Monitoring Office of Compliance Center for Devices and.

Public Health Surveillance

Incident Reports and field Safety Corrective Action ( FSCA) Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics.

1 Medical Device Safety Susan Gardner, Ph.D. Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health.

© 2013 Cengage Learning. All Rights Reserved. 1 Part Four: Implementing Business Ethics in a Global Economy Chapter 9: Managing and Controlling Ethics.

Lauren Lewis, MD, MPH Health Studies Branch Environmental Hazards and Health Effects National Center for Environmental Health Centers for Disease Control.

Session 8 EHDI Data Collection & Management in Washington State Washington State Department of Health Richard Masse, MPH Karin Neidt, MPH Caroline Maundu,

The Measurement and Evaluation of the PPSI Oregon Pilot Program Paint Product Stewardship Initiative Portland, Oregon December 10, 2009 Matt Keene Office.

PATRICIA KERBY, MPA HUMAN SUBJECTIONS PROTECTION COMPLIANCE OFFICER OFFICE OF RESEARCH COMPLIANCE What are the FDA’s expectations in 2010?

DEVELOPING EVIDENCE ON VACCINE SAFETY Susan S. Ellenberg, Ph.D. Center for Clinical Epidemiology and Biostatistics U Penn School of Medicine Global Vaccines.

Case for Quality Initiative Industry Perspective Monica J. Wilkins April 30, 2013.

Drug Safety and Risk Management Advisory Committee May 18-19, Overview of Drug Safety Challenges Gerald J. Dal Pan, MD, MHS Director Division of.

FDA Risk Management Workshop – Day #3 April 11, 2003 Robert C. Nelson, Ph.D. RCN Associates, Inc Annapolis, MD, USA.

Internet Organization Structure

Surveillance Key Points Dr. Oswaldo S. Medina Gómez.

July 15, Postmarketing Safety Evaluation of Approved Drugs and Risk Management Victor F. C. Raczkowski, MD, MS Director, Office of Drug Safety July.

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

FDA job description  Regulates about 25% of all consumer purchases  Mission summary: protect and advance public health  Products: food, cosmetics, drugs,

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

THE NATIONAL VACCINE PROGRAM OFFICE NATIONAL ADULT IMMUNIZATION PLAN OVERVIEW.

KENYA REVENUE AUTHORITY BUSINESS INTELLIGENCE OFFICE PRESENTATION INVESTIGATION & ENFORCEMENT DEPARTMENT SYMON YATICH 29 TH - 31 ST AUGUST 2012.

Valiants Verify Compliance Program Judith W. Spain, J.D., CCEP ® Chief Ethics and Compliance Officer General Counsel (Effective March 2016) 1.

Introduction to NCHS Rob Weinzimer, Special Assistant for Outreach Centers for Disease Control and Prevention National Center for Health Statistics.

Company LOGO Chapter4 Internal control systems. Internal control  It is any action taken by management to enhance the likelihood that established objectives.

OT 460 Week One Fall  Evaluation Process:  What client wants and needs to do  Determination of what the client can do and has done  Identify.

KEVIN BEDAL LISA CARLIN MATT CARROLL ERIN NICHOLS Product Safety & Failure Analysis.

Medical Product Safety Network (MEDSUN) an Interactive Surveillance System: Eliminating Barriers to Reporting and Creating Two-Way Communication with FDA.

Strengthening the Medical Device Clinical Trial Enterprise

Rachel Neubrander, PhD Division of Cardiovascular Devices

Evolving Importance of Post-Approval Studies

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Reasonable Assurance of Safety and Effectiveness: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division.

Adverse Event Reporting: Trials and Tribulations

Update on the National Postmarket Surveillance System

FDA Guidance for Industry and FDA Staff Summary of Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) Effective: December.

CDRH 2010 Strategic Priorities

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Medical Device Regulatory Essentials: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Lessons Learned Through HBD: The Regulator’s View - US FDA

HOW TO FULFILL STATUTORY REQUIREMENTS ON PRODUCT RELATED HEALTH INFORMATION Samina Qureshi, M.D. PSI INTERNATIONAL Inc.

HCA 375 CART Lessons in Excellence-- hca375cart.com.

FDA Resources and Meetings

Larry Kessler, Sc.D. Director

FDA Sentinel Initiative

Trending Requirements and Results

Regulatory Perspective of the Use of EHRs in RCTs

Presentation transcript:

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 1 Overview I.What DPS does… II.The Brick Model… III.Where Social Media Fits… Isaac Chang, Ph.D. Director Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 2 What does DPS do? Purpose: To conduct global post-market surveillance of medical devices and related emerging technologies through the regulation, collection, integration, and dissemination of adverse event data to identify and communicate actual and/or potential public health risks to FDA and public stakeholders. How we achieve our goal: Establish, interpret, and enforce requirements for medical device reporting (21 CFR Part 803- Medical Device Reporting); and provide outreach and education to FDA and public stakeholders to help them understand the requirements of the medical device reporting regulation. Monitor, analyze and synthesize adverse event data to identify signals (of new device issues) and trends (of known device issues); and to ensure that CDRH effectively uses adverse event report data in premarket review, postmarket evaluation studies, compliance and enforcement matters, and timely public health communications in support of the CDRH mission. Lead the continuous refinement and maintenance of the IT postmarket infrastructure to efficiently receive, process, retrieve, and analyze adverse event data in support of CDRH and FDA offices.

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 3 Medical Device Landscape

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 4 Medical Device Landscape

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 5 Best Use of MDRs Qualitative profile of adverse events for a device or device type – Device use in real world – Types of malfunctions/clinical events. – Vulnerable populations (i.e. Pediatrics, etc.) Monitor device performance – Time to event and failure modes – New types of issues with approved devices – Monitoring long term device use Signal detection – Rare, serious, or unexpected events – Change in severity of expected events – Use error/human factors issues

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance 6 Context is Important… 9/11 US loses AAA Credit Rating US Govt unveiled rescue of AIG Tensions Between N. andS. Korea TARP Stimulus plan Hurricane Katrina Successive Interest Rate Drops War concerns and bad corporate outlook Data Source: Timelines of History Database Dow Jones Industrial Average

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance The Brick Model 7 EVENT TRENDS BEHAVIORS PERCEPTIONS Signals Patterns/ Mechanism Incentives Interpretations Orientation Models Forecasts Resource Allocation OUTPUTOUTCOME Social Media

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance New approaches for Social Media Focus on the right target… – What is happening ----> Why is it happening – Confirmation of signals ----> Trend drivers – What are we seeing ----> What should we be seeing Weather analogy – College Park 86  – Dallas 94  – Chicago 67  8

M-CERSI Workshop – Envisioning the Future of Mobile Informatics Division of Postmarket Surveillance Summary Big Data Analytics is always built around what you are trying to find. The goal of analyzing Big Data is to re-focus efforts on the right problems. Play to the strengths of social media – explaining behavior and understanding how people think about issues. 9