Insights On Regulatory Compliance

  1. Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques 2/26/2025

    Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.

  2. Aiming For Success In Early mAb Process Development And Beyond 7/15/2025

    Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

  3. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  4. Why An Integrated Approach Ensures Smooth Entry Into The European Market 3/25/2025

    Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.

  5. Navigating Global Health Policy In A Time Of Disruption 8/12/2025

    The healthcare industries in the U.S. and EU are undergoing significant regulatory and legislative changes. Learn how to better position yourself to navigate this complex environment.

  6. Unfiltered: The Great PFAS Debate 8/7/2025

    Explore the global concern over persistent “forever chemicals” linked to health and environmental risks, as well as learn about regulatory debates, global restrictions, and why urgent action is needed.

  7. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

  8. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  9. Early Network Mapping To Guide HTA Literature Reviews 3/18/2025

    How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.

  10. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.