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  4. Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA - 01/29/2025
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Conference | Virtual

Event Title
Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA
January 29, 2025

Date:
January 29, 2025
Time:
9:00 a.m. - 4:30 p.m. ET

Agenda

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ABOUT THIS EVENT (Hosted by CDER SBIA)

FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications.

Although currently KASA primarily serves as an assessment tool, knowledge-aided assessment (KA) will be greatly enhanced when applicants submit structured applications (SA) with standardized data aligned with the assessment system. New initiatives such as revision of ICH M4Q guideline and pharmaceutical quality Chemistry, Manufacturing and Control (PQ/CMC) electronic data standards are intended to modernize regulatory submissions to be structured and standardized, which can significantly reduce the data management burden in KA. Such long-term efforts will augment quality assessment and registration of pharmaceuticals for human use by eliminating the need for transcription, increasing access to information, enabling analytics, streamlining regulatory assessment, facilitating surveillance of pharmaceutical product quality, increasing consistency and efficiency in regulatory decision-making and actions, and improving communication with industry.

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on quality documentation and quality portion of the submissions for pharmaceuticals for human use including IND/DMF/NDA/BLA/ANDA
  • Consultants focused on providing expertise on quality documentation and quality portion of the submissions for pharmaceuticals for human use including IND/DMF/NDA/BLA/ANDA
  • Clinical research coordinators working on clinical trial application filings to regulatory agencies
  • Foreign regulators involved in assessment of quality sections in the human drug submissions

TOPICS

  • Knowledge-aided Assessment and Structured Application (KASA)
  • Revision of ICH M4Q guideline
  • Pharmaceutical quality chemistry manufacturing and control (PQ/CMC) electronic data standards

OBJECTIVES

  • Describe KASA and its benefits
  • Discuss the relationship between knowledge-aided assessment and structured application
  • Explain the ongoing efforts to structured application
  • Describe the benefits of a structured application and its implications on product quality assessment and knowledge management

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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