Regulatory Insights

  1. Unlocking Potential AI And ML In Pharmacovigilance 5/13/2025

    Artificial intelligence (AI) and machine learning (ML) hold transformative potential in pharmacovigilance (PV), with the ability to enhance the efficiency, accuracy, and timeliness of drug safety monitoring.

  2. Accelerated Approval As The New "Norm" In Gene Therapy For Rare Diseases 5/13/2025

    Gene therapy has revolutionized treatment prospects for rare genetic disorders by enabling corrective or replacement strategies at the molecular level.

  3. Advancing The Implementation Of ICH E17 5/13/2025

    Explore the ICH E17 guidelines that provide a harmonized framework for designing and conducting multiregional clinical trials (MRCTs) to meet the regulatory expectations of multiple regions.

  4. How Early-Stage Planning Strategies Are Optimizing Drug Development 5/12/2025

    Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

  5. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

    This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

  6. Preparing For Change: Rare Disease Launches In The Era Of EU Health Technology Assessment (HTA) 5/9/2025

    Experts at Pharma 2025 discussed the impending EU Health Technology Assessment and its implications for rare disease product launches, highlighting key challenges and necessary organizational adaptations for the pharmaceutical industry.

  7. Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation 5/9/2025

    The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.

  8. Studying The Effects Of Drugs On Driving 5/9/2025

    Discover how early clinical cognitive testing and dedicated driving simulation studies can help assess the cognitive functions for safety and efficacy in drug development.

  9. Navigating The Complexities Of CNS-Active Drugs 5/9/2025

    In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

  10. Psychedelics And Entactogens: Challenges Associated With Schedule 1 Therapeutic Development 5/9/2025

    Industry experts explore the regulatory challenges of Schedule 1 drug development, including required studies, specialized assessments, and key formulation and manufacturing considerations.