Archives: Agenda

• Examining patient and site perceptions of direct-to-participant investigational product shipments
• Understanding how decentralized distribution models influence engagement, site workload and data integrity
• Exploring how AI is supporting trial design, operational efficiency and decision-making across the study lifecycle

• Strengthening inspection readiness through audit-ready documentation and traceability
• Mitigating risk through robust deviation and excursion management
• Enhancing compliance through strong vendor oversight and team preparedness

• Why phase‑appropriate logistics matters: Contrast early‑phase needs (speed, flexibility, limited batches) with later‑phase demands (cost efficiency, scale, partnerships).
• Defining scope + managing complexity: Clarify what logistics covers (R&D, CMC, clinical, cold chain, inventory, vendor management) and avoid “boiling the ocean” by right‑sizing processes.
• Building reliable systems: Align on cold‑chain qualification/validation, understand regulatory implications, and evolve tools from spreadsheets to integrated supply chain software.
• People & partners as drivers of success: Leverage SME expertise, combine AI with human intelligence, and manage vendors intentionally to support each clinical phase transition

• Valuation of clinical items moving through borders
• HS/HTS codes for blinded clinical shipments versus clinical supplies moving to distribution sites
• VAT expenses: how they apply, when and how they can be recovered
• Sanctions and exemptions in the pharmaceutical industry
• Overall best practices to approach your clinical studies from a customs perspective

• Multidisciplinary scientific evidence demonstrating high manufacturing quality, consistent product performance, shelf-life stability, and toxicological profiles that are substantially lower compared with those of combustible cigarettes and at or below those of FDA-authorized ENDS products.
• In a six-week study using a single, randomly assigned Breeze Pro flavor, approximately 10% of adults with no prior intent to quit smoking fully discontinued cigarette use, while close to 40% reduced daily cigarette consumption by at least 50%

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