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Cool Chain Brochure 2013.pdf - Sofrigam

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CONfeReNCe Day ONe:<br />

tuesday 29 JAnuAry 2013<br />

STREAM A: IMPLEMENTING STABILITY<br />

DATA AND LABEL CLAIM REQUIREMENTS<br />

TO PROTECT PATIENT SAFETY<br />

12.10 Handling Temperature Excursions and<br />

the Role of Stability Data<br />

• What does the regulator say about<br />

temperature excursions?<br />

• Reviewing the standard tests that facilitate<br />

decision making<br />

• How to increase stability knowledge to add<br />

value to our products<br />

Claude Amman, Director, Claude Amman<br />

Consulting<br />

12.40 5 minute change over<br />

12.45 PANEL<br />

Painting the Regulatory<br />

Picture<br />

• Expectations and boundaries for use of<br />

stability data<br />

• What will change in the GDP updates?<br />

• Achieving the ultimate goal of patient safety<br />

Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, United States<br />

Pharmacopeia<br />

Riekert Bruinink, Group Chairman of the<br />

PIC/S GDP Working Group, Member of the<br />

EMEA GDP Drafting, Dutch Health Care<br />

Inspectorate<br />

13.15 Networking Lunch Break<br />

14.30 Sponsor Spotlight Session<br />

This session is reserved for a leading supplier,<br />

if you think your product would be of interest<br />

to the delegation, get in touch on +44 207<br />

368 9300 or email sponsorship@iqpc.co.uk<br />

TAILOR YOUR AGENDA<br />

STREAM B: ACHIEVING SUPPLY CHAIN<br />

INTEGRITY AND ENSURING TOTAL DATA<br />

VISIBILITY TO MINIMISE RISK<br />

USP Chapter Good Distribution<br />

Practices—Supply <strong>Chain</strong> Integrity<br />

• An update of USP General Chapter <br />

Good Distribution Practices—Supply <strong>Chain</strong><br />

Integrity and industry comments<br />

• Implementing supply chain integrity<br />

measures to minimise risks that arise<br />

anywhere along the supply chain<br />

• Using GDP to develop sound business practices<br />

that help deter unauthorised access to and<br />

manipulation of pharmaceutical materials<br />

• Devising effective means for detecting<br />

adulterated drug components and drug products<br />

so that they do not enter the supply chain<br />

Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, United States<br />

Pharmacopeia<br />

Minimising supply <strong>Chain</strong> Risk<br />

Deployment of Solutions for End to End<br />

Data Visibility and Integrity<br />

• Identifying supply chain risks in managing<br />

cold chain distribution<br />

• Evaluating solutions to reduce temperature<br />

excursions<br />

• Using end to end services to ensure<br />

visibility and integrity of your temperature<br />

data<br />

Cathy O’Brien, Corporate Sector Manager<br />

Clinical, TNT<br />

Best Practice for End to End Visibility<br />

on your international Cold Supply <strong>Chain</strong><br />

using RFID Technology<br />

• Embedding monitoring and visibility<br />

strategies from the outset<br />

• Thoroughly qualification and briefing<br />

of suppliers to ensure full transparency<br />

throughout distribution<br />

• Effectively designing and setting up your<br />

supply chain<br />

• Successfully qualifying the whole supply<br />

chain to ensure it is robust<br />

• Reporting and Documentation, merges<br />

Event- and Temperature data<br />

• Always keeping in mind GDP guidelines<br />

Benjamin E. Blumer, Supply <strong>Chain</strong><br />

Manager, Horizon Pharma AG<br />

STREAM C: PACKAGING AND<br />

QUALIFICATION METHODOLOGIES<br />

Enhancing Profitability of your Cold <strong>Chain</strong><br />

Management by Improving Relationships<br />

with Your Partners<br />

• Achieving transparent communication: the<br />

importance of defining your constraints<br />

from the outset<br />

• Developing an adapted logistic and<br />

packaging programme<br />

• Test, evaluate and adopt<br />

Gilles Labranque, CEO, <strong>Sofrigam</strong><br />

The Role of Industrial Design in<br />

Temperature Assured Packaging<br />

• Understanding industrial design and its role<br />

in the industry<br />

• Examples of industrial design in industry<br />

• Temperature Assured Packaging and the<br />

challenges faced by the TAP Industry<br />

• Analysing success factors for design<br />

management<br />

• Implementation of the latest approaches<br />

and ideas for TAP<br />

Liam Holmes, Senior Project Engineer,<br />

ThermoSafe<br />

Multi-use, Single-use or Both? Economic<br />

and Ecologic Considerations of a New<br />

Packaging Provider<br />

• Assessing alternative, cost effective<br />

packaging solutions<br />

• Designing a sustainable supply chain and<br />

reducing your CO2 footprint<br />

• Recycling possibilities by technology<br />

• A practical guide to calculating sustainability<br />

Patrick Tobler, <strong>Cool</strong> <strong>Chain</strong> Specialist, Built<br />

Tech GmbH<br />

Live Shipment Performance Data within a<br />

Global Rental Network<br />

• An overview of ambient temperature<br />

profiles in real shipments<br />

• The impact of temperature profiles on<br />

container performance<br />

• Real life case studies<br />

Fabian Eschenbach, Business Unit<br />

Manager Thermal Packaging, Va-Q-Tec

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