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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

• 21 CFR 310.305 (prescription drugs marketed for human use without an approved application); 21 CFR 314.80 (human drugs with approved NDAs); 21 CFR 314.98 (human drugs with approved ANDAs); 21 CFR 600.80 (human biological products with approved BLAs), and section 760 of the FD&C Act (nonprescription human drug products marketed without an approved application).  
• Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document.   
• U.S. Department of Health and Human Services. Draft Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products including Vaccines. March 2001.  
• Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, US Food and Drug Administration. March 2005.
• U.S. Department of Health and Human Services. Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application. July 2009.   
• Guidance for Industry- Safety Considerations for Product Design to Minimize Medication Errors. April 2016.  
• Draft Guidance for Industry- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. April 2013.  
• Draft Guidance for Industry-Best Practices in Developing Proprietary Names for Drugs. May 2014.   
• MAPP 6720.5 Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351 of the PHS Act
• Guidance for Industry-FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry. April 2019
• Draft Guidance for Industry-Development of a Shared System REMS Guidance for Industry. May 2018
• Draft Guidance for Industry-Format and Content of a REMS Document Guidance for Industry. October 2017.   
• Draft Guidance for Industry-REMS Assessment: Planning and Reporting. January 2019.  
• Guidance for Industry-Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry. July 2019.   
• Draft Guidance for Industry-Providing Regulatory Submissions in Electronic Format — Content of the REMS Document Using Structured Product Labeling. September 2017.  
• Draft Guidance for Industry-Use of a Drug Master File for Shared System REMS Submissions. November 2017.  
• Draft Guidance for Industry-Waivers of the Single, Shared System REMS Requirement. June 2018.   
• Draft Guidance for Industry-Survey Methodologies to Assess REMS Goals That Relate to Knowledge. January 2019.  
• Guidance for Industry-Medication Guides – Distribution Requirements and Inclusion in REMS. November 2011.  
• Draft Guidance for Industry-How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. December 2014.   
• MAPP 6701.3. Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures. February 2019
• MAPP 4191.1. Risk Evaluation and Mitigation Strategies Modifications and Revisions. July 2019.   
• MAPP 6702.1. Risk Evaluation and Mitigation Strategy (REMS) Assessment. December 2019.  

 

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