Cencora OUTPH Insights
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International Reference Pricing (IRP): Foundations, Shifts, And What To Do Next
4/17/2026
As global pricing reforms evolve and policies gain traction, stakeholders must critically reassess the role of International Reference Pricing in balancing affordability, access, and incentives for innovation.
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Streamlining European Expansion With Integrated PV, Regulatory, And Commercial Expertise
4/17/2026
See how a single-provider model integrated pharmacovigilance with regulatory and commercialization support to support a scalable, audit-ready system that strengthened compliance and freed internal resources for growth.
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How Automation, Analytics, And AI Can Assist Safety Signal Management
3/4/2026
See how advanced analytics and human-in-the-loop systems are helping safety teams move beyond traditional disproportionality methods to manage complex biologics and growing case volumes.
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Best Practices For Managing The Logistics And Distribution Of CGTs
2/23/2026
Site infrastructure, formulary timelines, and storage capabilities create barriers between approval and patient access. Planning for these operational realities separates successful launches from stalled ones.
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Navigating EU Regulatory Challenges With Cell And Gene Therapies
2/23/2026
EU regulatory changes affecting advanced therapies demand new approaches to scientific advice, evidence generation, and health technology assessment for cell and gene therapy developers.
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The Value Of Real-World Evidence In Canadian Drug Commercialization
2/18/2026
Leveraging real-world evidence (RWE) across the product lifecycle enables manufacturers to fill the evidence gap beyond RCTs to help guide local commercial strategic planning and market access strategy.
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Digitized Solutions To Increase Visibility And Streamline Communication Between A PSP And Manufacturer
2/18/2026
When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.
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Digital Twins And Hybrid Models In Biologics Production: A Model Comparison
2/17/2026
Hybrid models outperform classical approaches in bioreactor prediction. See how combining mechanistic knowledge with machine learning builds process understanding that holds up beyond training conditions.
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As eCTD 4.0 Adoption Inches Forward, A New ICH Guideline Puts It To The Test
2/17/2026
Regulatory submissions are changing as eCTD 4.0 advances and the updated M4Q guideline reshapes how quality data is structured, cross-referenced, and reviewed across product lifecycles.
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Unlock The Potential Of Pharmacovigilance Outsourcing
2/17/2026
Outsourcing pharmacovigilance can reduce overhead, strengthen compliance, and free teams to focus on innovation. Examine what a well-structured global PV model actually looks like in practice.