Featured Insights

31. 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.

32. Overcoming Hurdles With A Contamination Control Strategy 7/26/2024

    Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.

33. 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.

34. EMA Adopts Collaborative Approach With ATMP Guideline Update 7/17/2024

    The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.

35. 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.