Cool Chain Brochure 2013.pdf - Sofrigam
Cool Chain Brochure 2013.pdf - Sofrigam
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