Featured Insights

  1. Optimizing Local Affiliate PV Operations 10/29/2024

    Discover how a global biopharmaceutical company partnered with PharmaLex to implement a streamlined, standardized model for international ICSR processing, compliance, and cross-functional collaboration.

  2. 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.

  3. How To Navigate The EU HTA Regulation For Better Market Access 10/21/2024

    The EU's new Health Technology Assessment Regulation poses challenges and opportunities for the biopharma industry, making manufacturers adapt to unpredictable PICOs and prioritize scenario planning.

  4. Empowering Healthcare Decision-Making 10/21/2024

    FormularyDecisions, now part of Cencora, has evolved significantly since its acquisition in 2019. Let's reflect on its journey, impact, and the future of formulary submissions in the digital age.

  5. The Unintended Consequences Of The Inflation Reduction Act (IRA) 10/21/2024

    Cencora PayerPulse provides insights into market access trends and the Inflation Reduction Act's impact on Medicare Part D, based on research from 41 advisors.

  6. The Use Of Meta-Analytic Predictive Priors In Clinical Trial Design 10/21/2024

    Discover how a Bayesian approach can revolutionize clinical trials by leveraging historical data to reduce sample size, increase power, and make more robust decisions.

  7. 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.

  8. 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?

  9. 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.

  10. 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.