12.30 - 15.30 Workshop A: Shipping Temperature Sensitive Clinical Supplies Internationally

The clinical trial supply chain is unique with a huge number of destinations, smaller packaging and added pressure to mitigate risks that could have a severe impact on expensive clinical trials. This workshop will focus on the operating challenges related to clinical trial supply of temperature sensitive IMPs and materials and how companies can establish achievable goals, select the proper tools and leverage cross-functional supply chain capabilities. Key topics include:

• Qualifying insulated boxes and packaging for international studies
• Choosing the right shipping material and solution in regard to route and IMP type
• Temperature monitoring of temperature sensitive IMP shipments with various temperature ranges and stability data
• Evaluation of temperature deviations and decision on action plan following temperature deviation to time-sensitive clinical drugs
• Use of local depots – is it neccesary, why and how?
• Develop SOPs with freight forwarders for new distribution routes
• Enforcing strict KPIs and quarterly review meetings with forwarder

Workshop Leader:

Rikke Ulslev Degn
Project Manager, CMC Clinical Supplies
Novo Nordisk

12.30 - 15.30 Workshop B: Managing End to End Transportation Processes to Prevent Loss and Minimise Risk

How do you control your cold chain? “Control” means, to check, monitor and verify by evidence. It should eliminate, prevent, minimise the risk of, and adjust to a requirement. In this three hour session, learn how active intervention management can prevent loss. Indeed, find out how you can answer vital questions such as, ‘What is happening? Where it’s happening? When it’s happening? What is the resolution?’ This session will provide you with the tools you need to:

• Prevent loss using proactive alerts
• Utilise historical data for continuous improvement
• Run thorough risk assessments of transportation service providers
• Conduct on-site audits, assessing the where, why and to whom
• Develop contractual agreements (SLA, TA, etc.)
• Create functional SOPs
• Run constructive review meetings

Workshop Leaders:

Federico Lupp
Head of Sales Europe and Latin America
LifeConEx, LLC

16.00 - 19.00 Workshop C: Re-Usability, Return-ability and the Realities of Sustainable Packaging Initiatives

• An overview of the regulatory guidance
• Lifecycle analysis and risk assessment
• Return and reverse logistics
• Re-using passive shipping systems
• Recycling of materials / carbon footprint and the use of environmentally friendly materials

Workshop Leaders:

15.45 - 18.30 Workshop D: Reefer Depot Site Visit: Understanding the Technology Advancement of Reefers and Temperature Monitoring Capabilities of Ocean Freight

15.45 Registration

16.00 Coaches depart WTC for Port Depot

18.30 Coaches return to WTC

This early evening ‘site visit’ will take participants to a reefer depot in the Port of Rotterdam to get ‘up close and personal’ to reefer containers. You will learn from reefer manufacturers and users what the capabilities, technological advancements and in-practice use of reefer technology are. If you are currently running pilots for sending temperature sensitive pharmaceutical via ocean, or are even considering it, you will not want to miss this unique opportunity to understand the key challenges, concerns and abilities of today’s reefer technology to handle your life science products. Points of interest and issues to be discussed include:

• There are close to a million refrigerated containers in operation today providing unparalleled connectivity across the globe
• Shipping by sea in refrigerated containers is the most carbon-efficient mode of transportation and produces fewer grams of CO2 emissions for each ton of cargo transported compared to any other form of transport
• Reefer container technology has advanced in recent years to be able to achieve very precise temperature control
• Back-up sensor protection and fail safe logic ensures that your cargo is always protected no matter what
• Reefer containers are also able to achieve very low relative humidity environments that are beneficial while transporting certain types of pharmaceutical goods
• In addition, real-time remote data monitoring provides visibility to your cargo to assure you that it’s being carried the way you want it
• These advances in technology have now made ocean transport a viable, sustainable and cost effective alternative for pharmaceutical companies

Site Visit Hosts: Carrier Transicold, Sensitech and APL