Halloran Insights
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Three Key Impacts Of ICH E6(R3) On RBQM And Oversight
9/16/2024
The drafted guideline ICH E6(R3), introduces significant updates impacting Risk-Based Quality Management. Explore three major ICH principles and key insights related to this guidance.
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Leveraging Outsourcing And Mixed Model Staffing Amid Layoffs
9/16/2024
In the face of layoffs or data-driven disruptions, choosing to adopt outsourcing or a hybrid staffing model can offer substantial cost savings by reducing overhead expenses like salaries and benefits.
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CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins
8/16/2024
In this presentation, speakers guide viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.
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How, Why, And When To Apply For An Orphan Drug Application
8/16/2024
Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset.
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Catching Up With Consulting — DIA 2024 Insights
7/12/2024
Explore the insights and perspectives from the DIA 2024 Global Annual Meeting to stay informed on the latest advancements in clinical trials and regulatory landscapes shaping the pharmaceutical industry.
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How Regulatory CMC Experts Navigate Expedited Accelerated Approval Timelines
7/12/2024
CMC experts stress that, despite adjusted timelines, stringent manufacturing and characterization requirements for product safety and quality remain, necessitating proactive planning to meet deliverables within the expedited approval period.
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The Quality Equation: 4 Essential Components To Enable Drug Development Success
6/18/2024
In this episode, experts share their insights on the four essential components for achieving quality excellence in clinical trials.
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Inspection Readiness Methodology: Failure To Plan Is A Plan To Fail
6/18/2024
Join us to learn how to stay inspection-ready throughout the clinical trial process and enhance your chances of market approval for your product.
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Raw Material Control For Biotechs (Part 2): Clinical Development Considerations
5/15/2024
Take a deep dive into several strategies being used to enhance raw material control to facilitate successful regulatory submissions and commercialization efforts.
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Leadership Considerations To Enable Clinical Development Success
5/15/2024
Explore several leadership examples that underscore the value of assembling the right expertise across organizations, facilitating successful outcomes, and cultivating a favorable track record for future investment opportunities.