Featured Insights

  1. Key Steps To Harmonize Medical Device Software Machine Learning Best Practices 8/30/2024

    Explore a draft guideline from the International Medical Device Regulators Forum (IMDRF) on good machine learning practices for medical device software development.

  2. Understanding The impact Of The EU's Updated SoHO Legislation On ATMPS 8/30/2024

    Learn more about the updated EU legislation on substances of human origin (SoHOs) and it's significant implications for advanced therapy medicinal products (ATMPs).

  3. Navigating The Regulatory Maze Of Targeted Medicines 8/30/2024

    Learn more about the importance of early engagement with regulatory agencies and collaborating with experienced authorities to streamline the review process and enhance market access.

  4. When Transcriptomics Meets Drug Repurposing 8/29/2024

    To support drug repurposing, transcriptomics is being used, which involves studying RNA molecules in cells to understand gene expression and identify potential drug targets.

  5. Transcriptomics Data Analysis: Overcoming Challenges In Medical Studies 8/29/2024

    Explore the challenges and solutions in analyzing transcriptomics data for precision medicine studies, emphasizing its potential in advancing personalized treatment approaches.

  6. Rebuttal: eCTD 4.0: More, Sooner! 8/29/2024

    Examine the complexities of targeted medicines and the recent discussion in the industry surrounding eCTD 4.0.

  7. Smart Steps to Managing Your TMF Audit Trail 8/29/2024

    Learn more about the importance of managing the audit trail for a Trial Master File (TMF) to maintain compliance and ensure data integrity.

  8. Lowering The TMF Temperature Through Quality Reviews 7/23/2024

    Clinical studies are fraught with risk, embedded in every TMF process. To avoid major findings during an inspection, knowing when and how to lower the TMF risk temperature is crucial.

  9. EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection 7/17/2024

    The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.

  10. Preparing The PMS: A Commercial And Regulatory Imperative 7/17/2024

    Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry.