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FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track

    May 29-30, 2024

    The Regulatory Education for Industry (REdI) Biologics Track focuses on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. The speakers presented updates on recent programmatic enhancements and initiatives from CBER product offices, including new regulatory programs and stakeholder communications, recent guidance documents, and highlights in the areas of innovation within the fields of biological product development. Regulatory considerations and practical recommendations was provided by speakers experienced in product application review.

    Intended Audience

    • Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
    • Regulatory affairs and other professionals working with submissions of INDs, IDEs, and BLAs to the Center for Biologics Evaluation and Research
    • Industry and consulting professionals working with advanced therapies, blood and vaccine products, and devices used with biological products

    Course Information

    Categories: ,

    Topics Covered

    • Regulatory submissions for cellular and gene therapy products and patient engagement
    • Licensure of blood establishments
    • Regulation of vaccine products
    • Post-marketing evaluation of biological products
    • Bioresearch Monitoring processes for CBER products

    Resources

    visit the FDA.gov webpage

     

    Enroll in the REdI 2024 Biologics Course

    FREE

    Enroll in the REdI 2024 Biologics course to access all lessons and resources.
    Create a free FDA Learning Cache account or sign in with your existing account to get started.

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    Supporting Resources – Access with FREE Enrollment (above)

    Download Presentation Slides & Transcripts
    Lesson 1 of 1 within section Supporting Resources – Access with FREE Enrollment (above). You must enroll in this course to access course content.
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    Session One: Innovation in Development of Advanced Therapies

    CBER Track Welcome
    Lesson 1 of 4 within section Session One: Innovation in Development of Advanced Therapies.
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    Regulatory Approach for Gene Therapies: Incorporating Human Somatic Genome Editing
    Lesson 2 of 4 within section Session One: Innovation in Development of Advanced Therapies.
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    Facilitating Development of Gene Therapies for Rare Diseases 
    Lesson 3 of 4 within section Session One: Innovation in Development of Advanced Therapies.
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    Q&A with Session One Speakers
    Lesson 4 of 4 within section Session One: Innovation in Development of Advanced Therapies. You must enroll in this course to access course content.
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    Session Two: Regulatory Communications, Part 1

    Overview of CBER’s Office of Communication, Outreach and Development
    Lesson 1 of 3 within section Session Two: Regulatory Communications, Part 1.
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    HCT/P Donor Screening/Testing and Requests for Exemption
    Lesson 2 of 3 within section Session Two: Regulatory Communications, Part 1.
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    Q&A with Session Two Speakers
    Lesson 3 of 3 within section Session Two: Regulatory Communications, Part 1. You must enroll in this course to access course content.
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    Session Three: Regulatory Communications, Part 2 

    Types of Regulatory Submissions
    Lesson 1 of 3 within section Session Three: Regulatory Communications, Part 2 .
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    Patient Engagement
    Lesson 2 of 3 within section Session Three: Regulatory Communications, Part 2 .
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    Q&A with Session Three Speakers
    Lesson 3 of 3 within section Session Three: Regulatory Communications, Part 2 . You must enroll in this course to access course content.
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    Session Four: Topics from Office of Vaccines Research and Review

    Use of Real-World Evidence in Accelerated Approval
    Lesson 1 of 4 within section Session Four: Topics from Office of Vaccines Research and Review.
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    Artificial Intelligence Challenges for Regulating Vaccine Development
    Lesson 2 of 4 within section Session Four: Topics from Office of Vaccines Research and Review.
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    CBER’s Advanced Manufacturing Programs for Sponsors
    Lesson 3 of 4 within section Session Four: Topics from Office of Vaccines Research and Review.
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    Q&A with Session Four Speakers
    Lesson 4 of 4 within section Session Four: Topics from Office of Vaccines Research and Review. You must enroll in this course to access course content.
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    Session Five: Post-Approval Safety of Biological Products

    Postmarketing Surveillance for Product Safety in Pregnancy
    Lesson 1 of 3 within section Session Five: Post-Approval Safety of Biological Products.
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    Update on the ICH E2D(R1) Guideline: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)
    Lesson 2 of 3 within section Session Five: Post-Approval Safety of Biological Products.
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    Q&A with Session Five Speakers
    Lesson 3 of 3 within section Session Five: Post-Approval Safety of Biological Products. You must enroll in this course to access course content.
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    Session Six: Topics from Office of Blood Research and Review

    Blood Regulation and Safety
    Lesson 1 of 3 within section Session Six: Topics from Office of Blood Research and Review.
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    FDA Regulation of HIV Tests
    Lesson 2 of 3 within section Session Six: Topics from Office of Blood Research and Review.
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    Q&A with Session Six Speakers
    Lesson 3 of 3 within section Session Six: Topics from Office of Blood Research and Review. You must enroll in this course to access course content.
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    Session Seven: Perspectives on Bioresearch Monitoring and Product Quality

    The Center for Biologics Evaluation and Research (CBER) Bioresearch Monitoring Program
    Lesson 1 of 3 within section Session Seven: Perspectives on Bioresearch Monitoring and Product Quality.
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    CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods
    Lesson 2 of 3 within section Session Seven: Perspectives on Bioresearch Monitoring and Product Quality.
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    Q&A with Session Seven Speakers
    Lesson 3 of 3 within section Session Seven: Perspectives on Bioresearch Monitoring and Product Quality. You must enroll in this course to access course content.
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