INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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Staying GMP Compliant: A Consultant's Guide To Compliance Bliss
GMP compliance ensures quality and safety in pharmaceutical manufacturing through regular assessments and continuous improvement, helping to prevent risks and keep processes efficient.
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Ensuring Quality In Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Quality Assurance (QA) ensures consistency and reliability in early-phase, small-batch production, fostering compliance through leadership support, collaboration, and continuous improvement.
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Risks To Consider When Implementing AI Technology In Medical Information
AI is used throughout MI workflows, but integrating AI comes with significant challenges. Explore these obstacles and proactive strategies to mitigate risks.
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FDA Drug Labeling Requirements & Regulations: What's In Your Label?
Explore the critical role of labeling and how a comprehensive approach enables alignment with clinical trial design, ensuring the label accurately reflects the product’s strengths and intended use.
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Strategies For Research Institutions In An Evolving Era Of Oncology11/11/2024
In this presentation, experts review cutting-edge trends and strategies that could help institutions address ethical and regulatory challenges as biomarker-directed therapies drive advancements in the oncology space.
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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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Maturity Model For Clinical Trial Disclosure11/11/2024
Learn about the eight key domains that are assessed by the clinical trial disclosure maturity model.
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Decoding MR-001: Navigating Its Impact On Clinical Trials In France11/11/2024
MR-001 plays a pivotal role in French clinical trials, shaping ethical standards and operational compliance. Learn how its influence is vital for stakeholders and sponsors advancing clinical research.
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Harnessing AI Beyond Chatbots to Innovate Medical Information Offerings11/11/2024
Take an in-depth look and the challenges and benefits of incorporating AI solutions to enhance Medical Information (MI) services and the necessity of regulatory compliance.
CLINICAL TRIAL REGULATORY SOLUTIONS
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Scout Academy's virtual clinical trial platform streamlines operations, ensures enhanced compliance and audit readiness, offers integrated learning management, and features a user-friendly interface.
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A labeling intelligence solution supports comprehensive product development, regulatory, and safety strategies, and efficient lifecycle management for successful product outcomes.
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This session explores the pivotal role of First-in-Human and early phase oncology trials in drug development, emphasizing the importance of comprehensive planning for successful execution.
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Review how Parexel's Oncology Site Alliance Network can support the accelerated timelines and flexibility required in early phase oncology studies.
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Chief Scientific Officer Gabriel Kremmidiotis and CEO Yvonne Lungershausen from Avance Clinical delve into key strategies for conducting successful early-phase oncology trials for biotechs.
REGULATORY MULTIMEDIA
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Strategies For Research Institutions In An Evolving Era Of Oncology
In this presentation, experts review cutting-edge trends and strategies that could help institutions address ethical and regulatory challenges as biomarker-directed therapies drive advancements in the oncology space.
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The Benefits And Challenges Of Clinical Trial Standards And Automation
Jessica Jolly discusses some of the benefits and challenges associated with implementing standards and automation in clinical trials.
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How will the ICH M11 guideline impact future clinical trials?
Hassan Khalid of AstraZenca talks about how he sees the ICH M11 guideline impacting future of clinical trials, specifically after a data lock.
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What does the data science industry have to say about the ICH M11 Guideline?
As the ICH M11 guideline nears approval, Hassan Khalid of AstraZenca and Jessica Jolly, a senior data and science executive, talk about how they feel about it and what they’ve been hearing from their peers in the data science industry.
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The Benefits Of The New ICH M11 Guideline
With 25 years of global data science experience, Jessica Jolly gives a quick overview of the ICH M11 guideline and talks about some specifics of its two pillars: standardization and automation.
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Addressing Opportunities And Challenges In Digital Health Data
Experts from diverse industry sectors unpack key points from the FDA’s final guidance on Digital Health Technologies (DHT) for remote data collection in clinical investigations.
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Driving Product Launch Success In Europe
Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.
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Harnessing The Power Of AI In Health Evidence Generation Strategy
Explore applications and limitations for artificial intelligence (AI) in healthcare as decision-makers determine whether to adopt the software in their environments.
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The Next Frontier In Early Phase Oncology Trials
This session explores the pivotal role of First-in-Human and early phase oncology trials in drug development, emphasizing the importance of comprehensive planning for successful execution.
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Anticipating And Adapting At Every Step Of Development
Review how Parexel's Oncology Site Alliance Network can support the accelerated timelines and flexibility required in early phase oncology studies.