Archives: Agenda

• Why is supply chain planning important?
• What are the foundational elements of successful supply chain planning for clinical trials?
• What does the Clinical Planner need to account for within their plan?
• What does the Clinical Planner need to effectively manage their plan?
• Which business processes are required to ensure the Clinical Planner keeps their plan current and accurate?

• Latest advancements with sourcing, labelling, and filing strategies for auxiliary medicinal product
• Identifying the right packaging and storage solutions based on your bespoke needs to accelerate your drug supply
• Improved expiry date predictions to avoid relabeling and reduce wastage
• Recognizing different labelling requirements globally and how to ensure total adherence: What are the implications of the revised Annex 13 on labelling of IMPs
• Enhancing label management with cloud-based technology to improve quality control and avoid
  unnecessary recalls

Chair: Bei Li, Senior Director, Clinical Supply  Management, Gilead Sciences

• Gaining enough traction for smallersoftware solutions companies with promising products to sustain their presence in the clinical ecosystem
• How to best implement innovative vendor services to ensure they work within the pre-existing CRO universe
• When CROs have too much power, how can we ensure innovation isn’t stifled?
• What are the best ways to balance risk mitigation and innovation in a traditionally slow-paced industry?

Chair: Mariam Iqbal, Director, Clinical Business Operations, Intercept Pharmaceuticals

• Advanced technology in clinical supply chain
• Case study – isolating objectives and delivering results through technology
• Emerging technologies, risks and regulatory considerations – identifying trial supply use cases for AI/ML

• Transitioning from existing capabilities  and architecture to integrating powerful new solutions to optimize trial supply
• Technology to determine next actions in preventing supply disruption, detect temperature excursions earlier and ensure patient safety
• Obtaining increased data points to validate or adjust predetermined excursion criteria
• Minimize discarding of potentially viable drug supply wi