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  4. Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies - 06/09/2020
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Webcast | Virtual

Event Title
Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies
June 9 - 10, 2020


Date:
June 9 - 10, 2020
Day1:
- ET
Day2:
- ET
 

Keynote

Gerald Dal Pan, MD
Director Office of Surveillance and Epidemiology (OSE)

Process for Reviewing Nonproprietary Name Suffix for Biological Products

Lubna Merchant, MS, PharmD
Deputy Director
Office of Medication Error Prevention and Risk Management (OMEPRM) | OSE

Best Practices for Proprietary Name(PN) Design

Danielle Harris
Deputy Director
Division of Medication Error Prevention and Analysis (DMEPA) OMEPRM | OSE

Preventing Medication Errors: Designing User Interfaces to Prevent Medication Errors

Lolita White
Team Leader
DMEPA | OMEPRM | OSE

Preventing Medication Errors: Lessons Learned from Postmarket Safety Survellance

Ashleigh Lowery
Team Leader
DMEPA | OMEPRM | OSE

Questions and Discussion

Ashleigh Lowery
Team Leader
DMEPA | OMEPRM | OSE

Division of Risk Management: Overview of Review Activities

Cynthia LaCivita
Director DRM | OSE
Jacqueline Sheppard
DRM | OSE

REMS Integration Initiatives

Gita Toyserkani
Associate Director for Research and Strategic Initiatives DRM | OSE

Development of Shared System REMS and Implications of the Appropriations Act

Elaine Lippmann
Senior Regulatory Counsel Office of Regulatory Policy (ORP)
Laura Zendel
Team Leader DRM | OSE

Considerations for REMS Surveys and Assessments: Planning and Reporting

Doris Auth
Associate Director
Division of Risk Management (DRM) | OSE
Shelly Harris
Team Leader DRM | OSE

FAERS Overview

Suranjan De
Deputy Director
Regulatory Science Staff (RSS) | OSE

IND Digital Reporting Overview

Meredith Chuk
Associate Director for Safety Office of Oncologic Diseases Office of New Drugs (OND)

Combination Products: Reporting Device Information and Malfunctions

Melissa Burns
Senior Program Manager
Office of Combination Products (OCP) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC)

ICSR Data Quality of Coding - Products, Adverse Events and Medication Errors

Sonja Brajovic
Team Lead
Manish Kalaria
MedDRA Coordinator
RSS | OSE

Postmarket Safety Surveillance

Eileen Wu
Associate Director Division of Pharmacovigilance I (DPV1) Office of Pharmacovigilance and Epidemiology (OPE) OSE
Judith Zander
Director
OPE | OSE

FDA's Sentinel Initiative

Danijela Stojanovic
LCDR | USPHS Epidemiologist RSS | OSE
Monica Muñoz
CDR | USPHS Deputy Director DPV1 | OSE

View Slides

This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products.  The training will include regulatory approaches to prevent medication errors, and the application of regulations and guidances to design labels and labeling to prevent medication errors. FDA will also discuss advances in approaches, tools, and technologies for medication error prevention, pharmacovigilance, and risk management. 

FEATURED TOPICS

  • Best Practices in Drug and Biological Product Postmarket Safety Surveillance
  • Safety Considerations for Product Design, Container Labels and Carton Labeling to Minimize Medication Errors
  • Process for Nonproprietary Name Suffix Review for Biological Products
  • FDA’s Sentinel Initiative and Sentinel’s role in safety surveillance
  • Overview of the Division of Risk Management and review activities
  • Development of Shared System REMS and waivers
  • Best practices for developing and reporting surveys for REMS  
  • Considerations for REMS Assessments – Planning and Reporting

 

LEARNING OBJECTIVES

Medication Errors

  • Design user interfaces (e.g., product design, labels, and labeling) to prevent medication errors
  • Describe general principles and special considerations in the design of container labels and carton labeling to minimize medication errors
  • Apply best practices to code and retrieve medication error reports
  • Assess reports to determine the type of medication error and causes or contributing factors
  • Understand how FDA evaluates and designates nonproprietary name suffixes for biological products

Safety Surveillance 

  • Summarize the purpose of post-market safety monitoring, the available data sources, methods and their associated limitations
  • Describe the risk-based principles by which FDA conducts postmarketing safety surveillance for drug and biological products
  • Understand the origins and key elements of FDA’s Sentinel Initiative and Sentinel’s role in safety surveillance
  • Distinguish between active and passive postmarketing surveillance

Risk Management and REMS

  • Understand role of Division of Risk Management in the application review process
  • Describe special considerations in the design and implementation of a shared system REMS
  • Describe lessons learned from the survey methodology guidance 
  • Describe FDA’s current thinking on REMS evaluations

FAERS

  • Describe the new features and capabilities of FAERS II
  • Understand the difference between E2B(R2) and E2B(R3)
  • Identify the two options for electronically submitting pre- or post-market Individual Case Safety Reports (ICSRs) to FAERS II
  • Describe what is the FAERS Public Dashboard
  • Describe minimum data elements to identify suspect products in ICSRs
  • Understand what is data quality in an ICSR

INTENDED AUDIENCE

This event is intended for industry, academia, payors, healthcare information providers, and healthcare providers who:

  • review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling; and
  • regulatory affairs professionals specializing in pharmacovigilance and risk management and labeling
  • MedDRA Dictionary teams;
  • foreign regulators;
  • consultants focused on medication errors, REMS, Human factors engineering, and adverse events;
  • healthcare professionals specializing in medication errors, REMS, Human factors and adverse events; and
  • patient safety organizations.

Resources

 

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