Featured Insights

31. 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.

32. 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.

33. Vigilance Guidance Provides Greater Clarity On MDR Requirements 6/12/2024

    Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.

34. How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements 6/12/2024

    See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

35. EMA's Concept Paper On Confirmatory Clinical Studies A Welcome Step For Industry 6/12/2024

    Explore the implications of the European Medicines Agency's Concept Paper, its potential impact on biosimilar developers, and the broader implications for the pharmaceutical industry.

36. Navigating Promotional Materials Requirements In Europe 6/12/2024

    From navigating local laws to strategic planning, explore how companies can manage their promotional campaigns while adhering to strict regulatory guidelines.

37. Opportunities And Risks As Biosimilars Come Of Age 6/12/2024

    As biosimilars mature, they promise expanded patient access and healthcare savings. Despite regulatory hurdles, collaboration and innovation will drive their future growth and impact.

38. A Collaborative Pathway To A Contamination Control Strategy 6/11/2024

    Embracing a collaborative approach, the concept of a Contamination Control Strategy (CCS) under Annex 1 is pivotal in safeguarding drug manufacturing quality and patient safety.

39. Navigating The Launch Of ATMPs In Europe 5/29/2024

    In 2025, EU's Health Technology Assessment will reshape market access for ATMPs. Proactive planning is crucial for developers to navigate these changes and ensure patient access to innovative therapies.

40. Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework 5/8/2024

    Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.