Featured Insights

  1. What The Shift To The EMA's PMS Means For Industry 8/30/2024

    Explore the implications of the shift to the European Medicines Agency's Pharmacovigilance System Master File (PMS) database for the pharmaceutical industry.

  2. Balancing Customization And Standardization With Targeted Medicines 8/30/2024

    Examine an overview of the challenges companies face in handling regulatory differences when manufacturing targeted medicines.

  3. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.