The management of temperature during the transportation of pharmaceutical products is undergoing a quiet revolution. What was considered to be a clear definition of ‘Cold Chain’ products is not subject to debate given the unprecedented changes in Regulatory and GDP Inspection requirements globally.
1. 3rd Annual Brussels Cool
Chain Network
Why Should I attend? The Brussels Cool
Chain Network:
2. The management of temperature during the
transportation of pharmaceutical products is
undergoing a quiet revolution. What was
considered to be a clear definition of ‘Cold
Chain’ products is not subject to debate
given the unprecedented changes in
Regulatory and GDP Inspection
requirements globally.
And perhaps as the key leveraging point
subject to the New EU guidelines on Good
Distribution Practice of Medicinal Products
for Human Use(2013/C 68/01).
3. The New Act calls on all products to be
Time and Temperature controlled;
Ambient. Hence the making of the old
‘Cold Chain’ obsolete.
A higher emphasis is placed on ‘systems
management’ and a call for 24-7
monitoring and recordings to be adopted.
As well as a key interest in
demonstrating the where about of
products at all times.
4. The handling of “cold chain” products and
the increasing number of products that
require temperature control is become
much more tightly regulated across the
entire pharma supply chain.
These sessions will highlight the latest
developments in the implementation
phase of the EU GDP, the different
interpretations within Europe and the
latest work on harmonising regulations
worldwide.
5. harmaDialogue (The life sciences division
of BusinessDialogue) spotted the new
trend approximately 3 years ago; and as
a direct result launched the Cool Supply
System and Solutions. Also known as the
Brussels Cool Chain network; where this
new trend and emphasis could be put
under scrutiny and engaged through
practical discussions: and in-depth case
studies.
6. We now suggest a fundamental shift
toward readiness for Good Distribution
Practices to be the underlining focus for
all players concerned with cool supply
systems and solutions.
There are several ‘Requirements’
interlinked to safe transport and storage
of time and temperature controlled
pharmaceutical shipments globally.
IATA, WHO IPEC, ANMAT Ley 26.492
Regulation (Argentina), USP General
Chapter 1079 to name few.
7. The Brussels Cool Chain network will
address what links, what fundamentals
and how various GDP requirements
interlock. While the secondary focus will
be on Logistics, Supply, Distribution,
Transport, and Storage and underlining
all of that will be addressing disruptions;
Time and Temperature Excursions.
8. Topics for 2014 range for ‘DATA’;
Falsified Medicine, Supply Chain
Integrity, new WHO technical report,
IATA New Requirements, Eurasian
Continent and Air Transport among
others.
Join 100+ cold chain professionals and
engage to learn and apply cool chain
logistics’ fail-safe techniques
9. Brussels cool chain 2014, Brussels cool
chain event and cold chain meeting in
relation to pharma logistics conference
but also New GDP. It is focused on good
distribution practice; Luxemburg Cool
Chain Conference, Cool supply system
and Solutions 2014 as well as the
Belgium cold chain conference 2014.
10. The Cool chain GDP inspection
conference will be discussing the New EU
GDP and Cool chain inspection. The main
interest is Time and temperature
controlled shipments and Ambient
pharma logistics.
11. That is to say Pharma transport
meeting; Vaccine supply chain
conference 2014 in relation to the Good
distribution practice Brussels Conference.
The
Luxemburg Cool Chain Conference 2014
is focused on Cool supply system and
Solutions 2014 assessing Belgium cold
chain conference 2014 and Cool chain
GDP inspection conference 2014.
12. If you are interested you should New EU
GDP Meeting Brussels so that Cool chain
inspection Brussels can address Time and
temperature controlled shipments as well
as Ambient pharma logistics Conference
2014. This is a seminar focused on EU
GDP inspection.
http://www.cold-gdp.com/dcenter.php