Cool Chain Europe 2010

Cool Chain Europe 2010 Agenda
Pre-Conference Specialist Discussions: 26th January

Biologic Clinical Supplies: Do Not Freeze
At this Specialist Discussion, you will join other supply chain, logistic and QA specialists dealing with the myriad of challenges shipping clinical supplies to many destinations around the world – often to remote areas or new markets. Exchange ideas and best practices on how to update your processes to be regulatory compliant in international markets and how to ship your temperature sensitive clinical supplies at lower risk profiles... all while adhering to the trial designs outlined by clinical research teams.

Main Conference Day One: 27th January
MHRA Regulatory Guidance: Ambient Transportation And Sufficient Stability Studies
Defining the key points of ambient temperature control requirements
Providing advice to pharma manufacturers for developing a global ambient temperature strategy
Stability studies versus shipping studies: What data is sufficient?
Responsibilities of distribution partners including wholesalers and making recommendations for quality checks and auditing

Main Conference Day Two: 28th January
From Air To Ocean Reefer Case Study: Increasing Control And Sustainability Of Our Temperature Control Shipments
Assessing sea transport partners and opportunities
Determining reefer reliability
Stringent controls on each end of the shipment to ensure minimal risk
The unplugging process and mid sea risks and repairs
Defining stability data that demonstrates adequate performance of shipping mode
Discussing the viability of shipping 2-8° by ocean.

Opening hours:
26th January :8.30-18.30
27th January : 8.30-19.30
28th January :8.50-17.40