Featured Insights

  1. 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?

  2. EMA Raises The Profile Of RWE With Key Reflection Paper 10/21/2024

    As the European Medicines Agency (EMA) finalizes its reflection paper on real-world evidence (RWE), the growing importance of this data source for regulatory decision-making becomes increasingly evident.

  3. The Complex Road To Developing Targeted Therapies 10/3/2024

    Developing targeted therapies is a complex journey, requiring a deep understanding of disease, innovative approaches, and close collaboration with experts.

  4. Regulatory Divergence Presents Barriers To EU Combined Studies 10/3/2024

    EU regulatory divergence creates hurdles for combined studies of medical devices, IVDs, and drugs. The COMBINE project aims to streamline the process and encourage more combined studies in Europe.

  5. Innovative Clinical Trial Designs For Orphan Drug Development 10/3/2024

    Explore how Bayesian methods and innovative trial designs can overcome challenges and streamline the drug development process, enabling faster access to life-changing treatments for rare diseases.

  6. Leveraging The Pharmacological Audit Trail For Clinical Drug Development 10/3/2024

    Discover how the Pharmacological Audit Trail (PhAT), an evidence-based framework, can streamline your drug development process, optimize dose selection, and enhance regulatory success.

  7. The Crucial Role Of Scientific Regulatory Writing For Drug Approval 10/3/2024

    Scientific regulatory writing is a cornerstone of drug approval. Learn how crafting clear, accurate, and compliant documentation helps ensure timely and efficient submissions.

  8. Key Considerations For Data Strategies In The Pharmaceutical Industry 10/3/2024

    Navigating the complexities of data strategies in the pharmaceutical industry. Discover the key considerations and approaches to unlock the full potential of your data.

  9. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.

  10. Targeted Medicines: Enhancing Efficacy, Safety, And Regulatory Success 8/30/2024

    Learn about the importance of pharmacological considerations in the development and marketing of targeted medicines.