Regulatory Insights
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Prioritizing Safety In Clinical Trials
8/27/2025
This presentation explores organizational culture and the values that are essential to delivering high-quality safety oversight.
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Why New Zealand Is Emerging As A Clinical Trial Hub
8/27/2025
New Zealand is rapidly emerging as a premier destination for clinical research, offering a unique combination of regulatory agility, scientific expertise, and cost efficiency.
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Navigating The Regulatory Complexities Of Targeted Medicines In Oncology
8/22/2025
Explore the strategic considerations for successfully navigating the regulatory complexities of targeted medicines. Learn about the challenges in translational medicine and key clinical development considerations.
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Project Orbis Drug Registration 2025
8/22/2025
Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.
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Unlock Oncology Success With A Comprehensive Commercialization Guide
8/22/2025
Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.
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Audit Trails And Transparency: Changes In Clinical Data
8/18/2025
Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.
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2025 Global Report For In-Vivo CAR Cell Therapy
8/14/2025
Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.
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LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations
8/14/2025
Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.
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Understanding Immunogenicity In AAV Gene Therapy
8/14/2025
As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
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Gene Therapy Studies Rose While Financing Declined In Q2 2025
8/13/2025
There were three new approvals across the therapeutic landscape in the second quarter of 2025, but despite those positive signs, overall dealmaking was flat for the quarter.