Featured Insights
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How Digital Innovation Can Inform RWE-Led Decision-Making
1/17/2025
Real-world evidence (RWE) is changing how healthcare products are developed and marketed. Learn how digital innovations are helping companies leverage RWE to make better decisions.
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Sterility Assurance With Louise Ui Fhatharta
1/17/2025
This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.
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The Bumpy Road Ahead: Stakeholder Perspectives On EU HTAR
1/17/2025
Experts convened at ISPOR Europe 2024 to discuss the upcoming EU Health Technology Assessment Regulation (EU HTAR), sharing insights and lessons learned from recent national reforms.
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A Year Of Reflection And Preparation
1/3/2025
The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.
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Anticipating The Top Market Access Trends Globally For 2025
1/3/2025
Navigate the shifting healthcare landscape that lies ahead. This report explores policy changes, market access trends, and strategies for ensuring patient access to innovative therapies.
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Five Steps To Preparing For The Product Management Service (PMS) Of EMA's SPOR Program
1/2/2025
EMA's Product Management Service (PMS) database is crucial for IDMP compliance in the EU. Prepare for PMS requirements with this 5-step checklist that helps ensure smooth data migration and compliance.
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Advanced Aseptic Filling Technology And Annex I Compliance
1/2/2025
NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.
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PIPA Conference Explores The Key Role Of PV
1/2/2025
The PIPA 2024 conference emphasized the importance of pharmacovigilance across the pharmaceutical industry, from mergers and acquisitions to clinical trials and health authority inspections.
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A Thoughtful Copay Program Design That Increased Patient Engagement
11/26/2024
Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.
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Managing Post-Market Regulatory Demands At The Local Affiliate Level
10/29/2024
Globalization presents both opportunities and regulatory challenges for the pharmaceutical industry. Many companies consider outsourcing regulatory tasks, allowing them to focus on strategic initiatives.