Archives: Agenda

• 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%

An exclusive invitation only yacht experience bringing together industry colleagues for an evening of refined networking and relaxation against the stunning backdrop of Miami.

Private Luxury Yacht: Venetian Lady

We close by focusing on the choices institutions can no longer defer, and the consequences of getting them wrong

• Where firms are overinvesting, underinvesting or moving too slowly
• The trade-offs between speed, control and competitive position
• What to stop, what to scale and what to redesign
• What will define winners and laggards over the next 24 months