Register HERE

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

Featured FDA SPEAKERS

Gerald Dal Pan, MD, MHS
Office Director
Office of Surveillance and Epidemiology | CDER | FDA

Claudia Manzo, PharmD
Office Director
Office of Medication Error Prevention and Risk Management | Office of Surveillance and Epidemiology | CDER | FDA

Lubna Merchant, PharmD
Deputy Office Director
Office of Medication Error Prevention and Risk Management | Office of Surveillance and Epidemiology | CDER | FDA

Judith Zander, MD
Office Director
Office of Pharmacovigilance and Epidemiology | Office of Surveillance and Epidemiology | CDER | FDA

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.

Register HERE