Tuesday, September 1, 2026

11:00 AM - 12:30 PM

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Details

Organised by the FIP Industrial Pharmacy Section in collaboration with the FIP Hospital Pharmacy Section Chair(s) Ms Amanda Cavness, Programme Committee Member, the FIP Hospital Pharmacy Section, USA & Ms Filipa Ferreira, Executive Committee Member, the FIP Industrial Pharmacy Section, Portugal Introduction: The biopharmaceutical landscape is evolving at an extraordinary pace, with the global market valued at over USD 450 billion (EUR 392.5 billion) in 2025 and expected to nearly double by 2032. This growth is propelled by breakthroughs in biologics, cell and gene therapies, and other Advanced Therapy Medicinal Products (ATMPs)-innovations that promise transformative outcomes for patients with serious or rare conditions. In response, regulatory systems worldwide have increasingly adopted fast-track and expedited approval pathways, enabling earlier approvals based on surrogate endpoints, limited clinical datasets, or real-world evidence. While these accelerated pathways aim to shorten the time to patient access, they have also contributed to a fragmented and inconsistent global regulatory landscape. This regulatory acceleration places immense strain on the industrial ecosystem. Manufacturing biopharmaceuticals is inherently complex, involving high costs, long lead times, process variability, and extreme sensitivity to storage and distribution conditions. Scaling from clinical trials to commercial volumes while ensuring consistent quality and compliance with Good Manufacturing Practice (GMP) standards remains a major hurdle. Compounding these challenges, the nature of fast-track approvals shifts a substantial evidence-gathering burden to the post-approval phase. This requires manufacturers to implement robust pharmacovigilance and adaptive risk management systems that can evolve as real-world experience accumulates. This session explores how regulatory policies can better reflect the practical constraints and capabilities of the industrial sector, while still safeguarding public health. Programme: Learning objectives: 1. Examine how regulatory policy can effectively balance accelerated access with safety, equity, and global reach - addressing the interplay between fast-track pathways, conditional approvals, and reliance models. 2. Identify opportunities to harmonise international regulatory practices by reducing fragmentation and advancing global scale-up through shared evidence standards, mutual recognition frameworks, and multi-stakeholder collaboration. 3. Explore stakeholder-driven approaches that engage patients, clinicians, pharmacists, payers, and global organisations to foster regulatory innovation that is both scientifically rigorous and socially equitable. Take home messages: Regulatory policy must align with industrial realities - adopting predictable, harmonized, and risk-proportionate approaches that accelerate safe access, foster cross-sector collaboration, and ensure equitable global outcomes through reduced fragmentation, sustainable affordability, and robust post-market oversight. Pharmacists and pharmaceutical scientists play a critical role in supporting safe use, pharmacovigilance, and post-approval evidence generation, contributing to long-term system resilience, sustainability, and “One Health” objectives. FIP Development Goals: To learn more about these FIP Development Goals, click on the links below. FIP Development Goal 14: Medicines Expertise FIP Development Goal 18: Access to Medicines, Devices & Services FIP Development Goal 19: Patient Safety

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