• Written summary in lieu of May meeting

    Below please find a summary of topics gathered in lieu of the AAPS Regulatory Sciences May 2024 meeting.

    • PharmSci360
      • Kim submitted eight topics (four on data management and four on QbD) and only one (#2 in the list below) was tentatively accepted (remaining suggestions were rejected):
        1. Data Security Strategies for Protecting Confidential Information in Pharmaceutical Industry
        2. Data Control and Data Security Management in Pharmaceutical Quality Assurance
        3. Digital Tools, Techniques, and Regulatory Considerations in Data Assessment
        4. How Data Integrity Impacts the Analysis and Decision Making
        5. Navigating Pharmaceutical Development with Quality by Design (QbD) Principles
        6. Strategic Implementation of QbD Approaches in Drug Development
        7. Elevating Pharmaceutical Development: Advanced Tools and Techniques for QbD Implementation
        8. Ensuring Compliance with QbD Principles Across Global Regulatory Frameworks
    • FDA draft guidance “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies”
      • Raja met with the review team to discuss the draft guidance and comments
        • Main issue: redundancy with other guidances that already address data integrity
        • Unclear what the bioavailability study means to FDA
        • Many other smaller comments as well
      • Boris will take all comments and communicate them to FDA from AAPS