Blogs

  1. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

    The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

  2. Five Steps To Preparing For The Product Management Service (PMS) Of EMA's SPOR Program 1/2/2025

    EMA's Product Management Service (PMS) database is crucial for IDMP compliance in the EU. Prepare for PMS requirements with this 5-step checklist that helps ensure smooth data migration and compliance.

  3. Advanced Aseptic Filling Technology And Annex I Compliance 1/2/2025

    NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.

  4. PIPA Conference Explores The Key Role Of PV 1/2/2025

    The PIPA 2024 conference emphasized the importance of pharmacovigilance across the pharmaceutical industry, from mergers and acquisitions to clinical trials and health authority inspections.

  5. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

    Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

  6. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  7. Managing Post-Market Regulatory Demands At The Local Affiliate Level 10/29/2024

    Globalization presents both opportunities and regulatory challenges for the pharmaceutical industry. Many companies consider outsourcing regulatory tasks, allowing them to focus on strategic initiatives.

  8. Key Steps For Achieving Annex 1 Compliance 10/21/2024

    The Annex 1 revision, effective since August 2023, sets compliance standards for sterile product manufacturing, emphasizing quality risk management and contamination control strategies.

  9. Exploring The Journey To eCTD 4.0 10/21/2024

    eCTD 4.0 promises to streamline regulatory submissions and enhance global collaboration. However, implementation challenges and evolving regulatory landscapes pose significant hurdles.

  10. MHRA Provides Details On Windsor Framework For UK Medicines 10/21/2024

    With the Windsor Framework implementation date looming, Northern Ireland will now have its own regulatory authority for medicines. But what does this mean for patients, manufacturers, and distributors?