Featured Insights

31. A Year Of Reflection And Preparation 1/3/2025

    The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

32. Anticipating The Top Market Access Trends Globally For 2025 1/3/2025

    Navigate the shifting healthcare landscape that lies ahead. This report explores policy changes, market access trends, and strategies for ensuring patient access to innovative therapies.

33. Five Steps To Preparing For The Product Management Service (PMS) Of EMA's SPOR Program 1/2/2025

    EMA's Product Management Service (PMS) database is crucial for IDMP compliance in the EU. Prepare for PMS requirements with this 5-step checklist that helps ensure smooth data migration and compliance.

34. Advanced Aseptic Filling Technology And Annex I Compliance 1/2/2025

    NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.

35. PIPA Conference Explores The Key Role Of PV 1/2/2025

    The PIPA 2024 conference emphasized the importance of pharmacovigilance across the pharmaceutical industry, from mergers and acquisitions to clinical trials and health authority inspections.

36. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

    Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

37. Managing Post-Market Regulatory Demands At The Local Affiliate Level 10/29/2024

    Globalization presents both opportunities and regulatory challenges for the pharmaceutical industry. Many companies consider outsourcing regulatory tasks, allowing them to focus on strategic initiatives.

38. 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.

39. 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.

40. 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.