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Programme

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8.30		Registration & Coffee
9.00		Chairman's Opening Remarks Frank Reale, Global Regulatory Operations, Merck View Bio
9.10		The logistics of providing cold chain investigational clinical supplies in a global environment Frank Reale, Global Regulatory Operations, Merck View Bio How "Not So Apparent Regulations" impose hurdles and roadblocks for the safe and timely delivery of Investigational Clinical Trial material. Country specific regulations that can be imposed that are specific to any given country Regulations on investigational clinical supplies: the differing commercial material and potential delays, detentions, seizure of material and possible destruction Understanding these regulations to ensure timely and safe delivery of material
9.50		Current and Future Regulation of Cold Chain products Ian Holloway, Manager, MHRA View Bio Current GDP Guidelines and cold chain distribution  Revision of Annex 16 of the GMP Guide and likely impact on cold chain operations  Security within the supply chain and the Falsified Medicines Directive
10.30		Morning Coffee
11.00		A chemistry-based device with on-off switches for the profiling of temperature during cold-chain distribution Long Lin, Professor/Director, University of Leeds View Bio Background to the TSB-funded research and development project A survey of various existing chemistry-based temperature monitoring devices The importance of on-off switches in monitoring devices Novel chemistry-based device with on-off switches
11.40		The auditing of a transport company Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier View Bio Understand the audit process for transport companies and know what to focus on Identify key audit criteria to ensure operational conformity and optimum results Consider the regulatory requirements and how to streamline these with transport options
12.20		Networking Lunch
13.40		Panel Discussion: Perspectives and opinions on auditing in cold chain distribution Frank Reale, Global Regulatory Operations, Merck View Bio Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline View Bio Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier View Bio Harvey Rubin, Director, University Of Pennsylvania View Bio Delegates will be given the opportunity to discuss as a group auditing in the cold chain industry Individuals will be able to put forward comments and thoughts on each of the topics raised within the discussion forum The topics and points raised will be included in the conference literature Delegates will be given the opportunity to discuss as a group auditing in the cold chain industry Individuals will be able to put forward comments and thoughts on each of the topics raised within the discussion forum The topics and points raised will be included in the conference literature Delegates will be given the opportunity to discuss as a group auditing in the cold chain industry Individuals will be able to put forward comments and thoughts on each of the topics raised within the discussion forum The topics and points raised will be included in the conference literature Delegates will be given the opportunity to discuss as a group auditing in the cold chain industry Individuals will be able to put forward comments and thoughts on each of the topics raised within the discussion forum The topics and points raised will be included in the conference literature
14.20		Applying Cold Chain Reporting and Analysis of Key Performance Indicators (KPIs) for the Application of Continuous Process Improvement Richard Peck, Senior Program Manager Life Sciences EMEA, Sensitech UK Ltd View Bio Why Data Management is critical for managing temperature-sensitive supply chains Review of regulation and guidance regarding Good Data Management and Good Documentation Practices Review of available business analysis tools to support continuous improvement
15.00		Afternoon Tea
15.30		Energize the Chain: Bringing Vaccines to the Most Remote Parts of the Globe Harvey Rubin, Director, University Of Pennsylvania View Bio Statement of the problem: The cold chain degrades the further away from the central storage points in the developing world The extent of the problem: 2.5 million children die of vaccine preventable causes The solution to the problem: Utilize energy available at cell towers sites to power vaccine refrigeration units even in the most remote parts of the world Implementation: Public private partnerships organized through our non profit organization--Energize the Chain  Examples of implementation: Zimbabwe and other countries
16.10		Control Temperature processes along the supply chain Yoram Eshel, Senior Director, Global Transportation & Logistics, Teva Pharmaceutical View Bio CRT Vs. Ambient – do they really maintain the required temperature? The current paradigms about controlled temperature shipments. How CRT shipments look like in real life? How to practically mange your controlled temperature transportation
16.50		Chairman’s Closing Remarks and Close of Day One
17.00		Drinks Reception
19.00		Networking Dinner The first day of the conference will be followed by a Networking Dinner at the Gilgamesh Restaurant; available for pharmaceutical companies Hosted by World Courier, this will allow for networking and discussion of the cold chain industry in a more informal setting Delegates to ensure they are in the Adelaide Suite by 18.45, Bus leaves at 19.00 prompt

8.30		Registration & Coffee
9.00		Chairman's Opening Remarks Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier View Bio
9.10		The Management of Logistics Risks in the Pharmaceutical Supply Chain Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline View Bio Understanding the pharmaceutical supply chain Identifying and assessing risks before and during the supply chain process Mitigating risks as effectively as possible Resources to help all companies improve their supply chain process: with specific cold chain examples
9.50		Data Management in the Cold Chain Distribution Mathieu Materne, Global IT Validation Coordinator, Ucb Pharma e-records in the pharmaceutical environment Cold Chain data identification: methods and techniques Cloud Computing : the easiest ways to implement a worldwide system Reporting and data management, and examples of each Interfacing, new technology and more
10.30		Morning Coffee
11.00		Cold chain distribution in resource-poor countries Amina Jindani, Honorary Senior Lecturer, St George's, University of London View Bio Outsourcing clinical trials in resource-poor countries The regulations in different countries and how this affects the cold chain process Maintaining the cold chain for drug shipments: tools and techniques Maintaining the cold chain for sample transfer The eventual outcomes of the supply chain, and an example of a cold supply chain in a resource-poor country
11.40		Understanding and analysing Cost of Quality (CoQ) Robert Hayes, Director, Cold Chain Consultants View Bio Understanding the difference between Quality Assurance and Quality Control Current regulatory thinking on managing quality The Cost of Quality Model: assessing the cost of quality for internal and external activities for prevention and appraisal Managing cost of quality to achieve best operational value
12.20		Networking Lunch
13.40		Achieving traceability based on GS1 Standards Roger Lamb, Healthcare Manager, GS1 UK View Bio Overview of important regulatory and industry developments GS1 Standards for Healthcare: Process and technical (“Identify, Capture, Share”) standards The Global Traceability Standard for Healthcare (GTSH) Examples of successful implementations of standards
14.20		Choosing an adequate temperature measurement procedure and device to insure a declaration of conformity without unknown risk Eric Devin, Development managing director, Cemafroid View Bio The  theorical  basis of uncertainties, the impact on the validity of a declaration of conformity and its consequential interference on the true temperature of medical products Medical components which are temperature sensitive especially in the  domain (+2, +8°C) Transportation and storage of blood or vaccines
15.00		Ensuring Quality During Cold Storage: Lessons from Biobanking John Cason, Director, Kings College London View Bio Dealing with labile biological materials Monitoring sample quality throughout storage What biobanking can teach us about cold chain storage and how to apply these lessons learnt Future challenges in the industry
15.40		Chairman's Closing Remarks and Close of Day Two

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