Regulatory Insights
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2024 Safety And Regulatory Compliance Trends And Predictions
12/26/2023
The introduction of artificial intelligence and machine learning into pharmacovigilance, safety, and regulatory workflows stands to have a major impact on process efficiency and employee workloads.
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High-Velocity Development: Gene Therapy Vs. Small Molecule
12/26/2023
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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NIH 2023 Data Management And Sharing Policy FAQs
12/19/2023
Uncover how the DMS policy intends to promote transparency, collaboration, and the rapid transformation of research outcomes into tangible advancements for the betterment of human health.
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Operational Disruption: Assuring Clinical Data Integrity
12/19/2023
Explore three essential insights for effective protocol preparation and managing disruptions mid-stream to safeguard the integrity of clinical data.
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What FDA, EMA Discussion Papers Reveal About AI In Clinical Research
12/18/2023
Learn how having a comprehensive understanding of regulatory perspectives on AI ethics will prove invaluable for researchers evaluating the integration of AI technology into their trials.
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Drug Review Profiles: A Deep Dive Into New Drug Approvals
12/18/2023
Explore the dynamics behind interesting and sometimes precedent-setting new drug approvals and uncover how the regulatory process works in practice.
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Regional Comparisons Of Pharmaceutical Regulations
12/18/2023
Uncover how performance and regulatory expectations differ for regulatory agencies in various markets, influenced by regional drug review trends, approval decisions, and regulatory guidance.
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Practical Applications Of ICH E6(R3): What Do We Need To DO?
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Digital Endpoint Resource Guide: Respiratory
12/8/2023
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions
12/8/2023
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.