Just before the NEMO Meeting in Amsterdam scheduled for the 24th and 25th of September 2012 I would like to take the opportunity to remind you of the previous meeting of the NEMO PCC and PGB. As always the minutes of all meetings can be found on the milliarium website https://www.milliarium.gabo.de/Forms/Generic/Security/frmLogin.aspx
TheKick-off meeting in Cork (28-30 October 2009) was well attended with people from across the 16 centres. Participants were welcomed by the coordinator, Dr. Ronit Pressler and co-PI Dr Geraldine Boylan. The Scientific Officer, Dr. Fergal Donnelly welcomed all members on behalf of the European Commission and congratulated the consortium of NEMO on gaining the grant from the European Commission. He pointed out the importance of this project for the healthcare of children.
Shortly before the 2nd meeting in London (7-9 April 2010 2nd PCC meeting) the NEMO project website went online on 6th April 2010. The website and its different sections were presented at this meeting by the project manager Judith and the consortium was informed that a project flyer was being developed by GABO:mi.
The study website of the NEMO-1 study available at: www.nemo-study.com was presented at the meeting in Helsinki (26- 28 September 2010 Helsinki, 2nd PGB meeting). It was stressed that NEMO was one of the first consortiums within the FP7 framework program which included a US partner.
The meeting in Marseille (11- 12 April 2011, 4th PCC meeting) addressed the first periodic report which has to be finalized by May 2011. The coordinator gave an update of the progress of the clinical trial, presenting the protocol changes and the current status of ethics and CTA submissions. An overview of all ethics and regulatory status was provided. SOP for Pharmacovigilence was ready for approval, The monitoring agreement also in place. Trial Master File Plan draft completed. It was expressed that the Green light for the opening of the first site is expected for the end of April 2011.
At the meeting in Stockholm among others the Trial Steering Committee provided an update on status quo: the fact that the TSC Charter has been signed and a core TSC team named the Trial Management Committee has been established with biweekly meetings. The two sponsors GOSH and O4CP gave an update and shared inspection findings.
Attended by participants from across all the centres the meeting in Munich (19- 20 September 2011, 3rd PGB meeting) allowed a review of progress so far in the NEMO Clinical Trial. A key discussion focused on recruitment rate presented and it was agreed that the centres of Necker, IPP and Helsinki would be closed. There are two new potential centres University Hospital Tours in Lyon France and Kings College Hospital London UK. A clinical overview, a discussion on the SAE reporting process for NEMO and the recent DMC meeting and their response following the review was presented.
Team building exercise!
I look forward to meeting you again at the meeting in Amsterdam and would like to take the opportunity to remind you that the meeting in Brussels is scheduled for April 25-26 2013 and the following meeting in Royaumont (near Paris CDG) is scheduled for September 23-24 2013.