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

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• Sustaining community outreach and engagement through CISCRP’s Journey to Better Health Mobile Unit
• The impact on perceptions and behaviors with regards to clinical research
• Partnering with community educators, drawing attention to the need to be aware of clinical research

• Changing foreign relations priorities in US
• History of the US BioSecure Act, its future, and potential impact on the Pharmaceutical Industry
• US pharma industry reliance on foreign CROs and CDMOs to advance research
• Risk assessment for companies with ongoing drug development activities with a foreign CRO/CDMO