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January 5, 2012 - Common European Submission Platform: Extended Proof of Concept
Under the remit of the Heads of Medicines Agency (HMA), a
group of Agencies and Industry Representatives have been
working to investigate the feasibility for the development of
a Common European Submission Platform (CESP). A Proof of Concept
was run during September and October 2011 and following its
success the next steps for CESP were agreed at the Heads of
Medicines Agency (HMA) meeting in November 2011.
Approval was given to proceed to set up two sub Groups of
CESP, a governance group and solutions group. This last group is
looking at the current development and longer term development of
CESP. They are also responsible for running an extended Proof of
Concept (PoC).
What will this extended PoC entail?
The extended PoC will start towards the end of January 2012
and will continue until a final decision is taken on the
development of CESP, due to be submitted back to the HMA in June
2012.
The most significant difference between the extended PoC
and the PoC in 2011 is the submission of live
applications. We recommend that during this phase these
applications are submitted in parallel to your current submission
of CD-Roms/DVDs. Clear instructions on how to do this will be
published on our CESP Webpage, http://cesp.hma.eu.
The extended PoC will set out to establish the following
(amongst other things):
- cutting the burden from both an Industry and Agency perspective
of handling CD-Roms/DVDs;
- analysing any limitations in submitting applications via this
method;
- the extended PoC will include testing MRP, DCP and national
applications.
We already have a number of Industry colleagues who have joined
the initial CESP PoC; if you are one of these then please let Kevin
Horan (kevin.horan@imb.ie)
know that you wish to continue with the extended PoC.
Please follow the link http://cesp.hma.eu and follow the
registration process. A training session will be held on the
23rd of January to which you will receive an
invitation if you have registered before this day. This session
will last a maximum of 2-3 hours long and will take you
through the CESP Website, the process of uploading and details of
the requirements to work with CESP. We need all interested
parties to register on CESP by the 23rd of
January.
If you are already registered then please do not re-register
as indicated above, but let Kevin Horan (kevin.horan@imb.ie) know that you
are interested in participating in the extended PoC.
Further information
For those of you who did not participate in the original PoC,
the following will give you an idea of anticipated effort and any
additional requirements:
- You need to set up a technical connection to CESP which will
require IT support; this is likely to require approx. one day and
specific details of technical requirements will be given to you
following registration on the system.
- There are two options for transferring files via CESP: a Web
based solution or installation of a client which does attract small
fee; alternatively you can use your own secure FTP server.
- A short test to check set-up and upload should be undertaken;
this will take approximately 20 hours and will include full
end-to-end testing.
- All participants will be invited to attend teleconference
sessions to check and give feedback on how the PoC is going. You
may also be asked to give feedback via a survey. These will be
ad-hoc but any one should not exceed 2 hours and a maximum
frequency will be once a month.
For questions related to this message, you can also contact Stan
van Belkum (ca.v.belkum@cbg-meb.nl).
On behalf of the CESP Solution Development Team.
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