EUCROF to comment on Revision 1 of the ICH E9 Guideline

The Clinical Trial Legislation Working Group is wishing to comment on the Revision 1 of the ICH E9 Guideline “Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials”

However, given the Guidelines focus on statistics, the CTL WG is calling on any member with an expertise in this area to come forward with comments no later than Friday 16th February.

If you are interested in helping and providing comments to the CTL WG please contact Dagmar Chase, Chair, at This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

 

 [Back to e-News January 2018]

 

Board members presenting at more events in the coming months…

  • Donato Bonifazi (newly-elected President of the Italian Association AICRO) presented at a conference TEDDY (European Network of Excellence for Paediatric Clinical Research General Assembly) - A New Phase for Paediatric Clinical Research: a Role Play for TEDDY – Rome (Italy) on 14 January 2018. For further information please contact Dr Donato Bonifazi at This email address is being protected from spambots. You need JavaScript enabled to view it..
  • Dr Martine Dehlinger-Kremer (President), and Dr Stefano Marini (Vice-President attended respectively via teleconference and in person, the kick-off meeting of the ID-EPTRI project (European Paediatric Translational Research Infrastructure) lead by Donato Bonifazi ,in Rome on 15 and 16 January 2018. For further information please contact Martine Dehlinger-Kremer at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

 [Back to e-News January 2018]

 

EUCROF attending EMA Stakeholder meeting on the EU Clinical Trials Portal and Union Database, 25 April 2018 in London.

The focus of this meeting will be the ongoing development of the EU CT Portal and Database and will be attended by industry and academic stakeholders, as well as representatives from Member State regulatory authorities. EUCROF will be represented by Dr Martine Dehlinger-Kremer (President), Dagmar Chase (Chair Clinical Trial Legislation Working Group) and Simon Lee (Secretary). This is the first meeting that is scheduled to take place in 2018. These meetings are to discuss this important topic ahead of the implementation of the European Clinical Trials Regulation in 2019 and look at the progress being made with the EU CT Portal and Database.

 

We will keep you all posted on future developments in this important area, but if you have any questions please don’t hesitate contacting Simon Lee at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

 [Back to e-News January 2018]

 

EUCROF now participating in forthcoming ENCePP’s Working Group 2 “Independence and Transparency”…

It is great news that the EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), confirmed the membership of our colleague, Dr Xavier Fournie, in the ENCePP Working Group 2 “Independence and Transparency”.

This working group is chaired for ENCePP by Dr Laura Yates (Consultant in Clinical Genetics at the Institute of Genetic Medicine in Newcastle upon Tyne, Honorary Clinical Senior Lecturer in the Institute of Human Genetics Newcastle University, head of the UK Teratology Information Service) and for the EMA by Dr. Thomas Goedecke, PharmD (Principal Scientific Administrator, Surveillance and Epidemiology Inspections, Human Medicines Pharmacovigilance & Committees Division, EMA).

 

To find out more please CLICK HERE for the recent press release…..

 

 

[Back to e-News January 2018] 

 

Next General Assembly is on 25th May in Bratislava.

With the help and support of our Slovakian colleagues of SACROP, we are organizing our next General Assembly in Bratislava, scheduled on 25th May 2018 (social event on Thursday 24th, in the evening).

You are cordially invited to attend the General Assembly and each association/partner is invited to send at least one representative.

More information will be sent to all our member associations in due course, but for now put this date in your calendar!!

We are looking forward to seeing you all in Bratislava!

 

In the meantime, if you have any questions, please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

 [Back to e-News January 2018]

 

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