PCMG Annual Conference in Copenhagen in June

The Pharmaceutical Contract Management Group is holding its annual conference in Copenhagen this June. The venue will be the Radisson Blu Scandinavia Hotel, Copenhagen, Denmark and will be between the 7th and 9th June 2017.

For further details on the conference visit www.pcmg.org.uk or contact This email address is being protected from spambots. You need JavaScript enabled to view it..


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EUCROF’s President to attend Enpr-EMA Annual Workshop in May

Martine Dehlinger-Kremer will be attending the Enpr-EMA Annual Workshop in London on 16 May.

This will be the ninth annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) which aims to bring relevant stakeholders together to discuss requirements, barriers and opportunities for high-quality clinical studies in children. Among the highlights of this year’s workshop are the recent efforts to increase cooperation between the European Union and the United States to facilitate global paediatric trials and medicine developments.

For further information please contact Martine Dehlinger-Kremer at This email address is being protected from spambots. You need JavaScript enabled to view it..


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EUCROF to attend Good Clinical Practice Inspectors Working Group (GCP IWG) in June

The Good Clinical Practice Inspectors Working Group (GCP IWG) will be holding a joint meeting with interested parties on 12 June 2017 from 11.00 until 18.00 at the premises of the European Medicines Agency.

The title of the meeting is: “Meeting with interested parties on topics related to e-source data/ EDC tools in clinical trials”

The meeting is to address some of the hot topics in clinical trials, including:

  1. Inspection findings related to e-systems & their vendors  
  2. Risk based software validation
  3. Requirements for a good audit trail
  4. Electronic informed consent

Building on the experience of the previous meetings, we would like to explore solutions for some of these topics and therefore balance the time allocated for presentations with discussions and comments sessions.

EUCROF has been invited to provide 3 to 4 experts in the field to attend and a call went out to Members last month and is now closed. Final names of EUCROF experts in the field have just been confirmed as follows:-

Yoani Matsakis

Dagmar Chase

Stefanie Broes

Michele Garot

Ana Patacão

Alan Yeomans

The proposed list of speakers are:

  • Contractual requirements on the responsibilities of e-systems vendors with regards to GCP by Yoani Matsakis and Dagmar Chase
  • Views on the implementation of a risk based approach to computer systems validation by Yoani Matsakis
  • Methodologies used for system validation (e.g. Agile methodologies) and documentary evidence produced by     Yoani Matsakis and Alan Yeomans.
  • Electronic informed consent by Stefanie Broes

For further information please contact Assia Rosati at This email address is being protected from spambots. You need JavaScript enabled to view it. and Martine Dehlinger-Kremer at This email address is being protected from spambots. You need JavaScript enabled to view it..


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1st Kiev Clinical Research Forum, November 2017

PHARMASICH CRO with the support of the European CRO Federation holds Kiev Clinical Research Forum on 9-10 November 2017 in Kiev, Ukraine.

The Forum is the unique discussing platform for clinical research industry in Eastern Europe.

It will bring together 300 delegates and the speakers from 14 countries, representing the industry, regulatory agencies, academia and non-profit boards and will provide awesome networking opportunities and adequate discussion between speakers and audience.

The full programme and other details are available on the conference website:


If you wish to make a presentation or take part in the panel discussion, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

 Or, alternatively, we can set up a call to discuss the details.


[Back to e-News May 2017]


EUCROF’s next webinar is on 13TH June 2017, register now!

EUCROF’s next scheduled Webinar is on the 13th June and will cover “Extrapolation approach in paediatric clinical research: chances and bottlenecks”



In the last decades, it has been widely accepted that the development of medicines for use in children should undergo strict qualitative, ethical and procedural rules, in order to appropriately authorise them for paediatric use. 

Thus, considering the vulnerability of this population, all the efforts to minimise unnecessary studies in children have to be made. Moreover, economic burdens and methodological, feasibility and ethical issues strongly impact on the number of children that can be enrolled into a clinical trial and this becomes more complex in the case of rare diseases. For this reason, new methodological strategies have to be explored to exploit the rich source of data that are already available, especially for the adult population.

In this scenario, the extrapolation approach, intended as “extending information and conclusions available from studies in one or more source population, to make inferences for another target population”, is an important tool to adopt when planning a paediatric medicine development programme, possibly allowing for a reduction in new data to be generated for conclusion in paediatric populations.

This approach has been included in the recent ICH-E11 guideline revision and is increasingly adopted in the official paediatric development plans proposed to EMA and FDA.

This webinar will provide an overview of the use of extrapolation of efficacy and safety data in paediatric medicine development, pointing out positive experiences and difficulties. A case-study and several examples will be presented.

After this webinar, participants will have better awareness of the opportunities and the requirements for the extrapolation approach in paediatric medicines development, with a particular insight on the regulatory scenario.



The total duration of the webinar, including Q&A, will be approx. 1.5 hours



Dr. Lucia Ruggieri

MSc in Paediatric Medicines Development and Evaluation

Researcher at Gianni Benzi Pharmacological Research Foundation

TEDDY Network Scientific Secretariat


Please contact Antoinette Van Dijk (This email address is being protected from spambots. You need JavaScript enabled to view it.) for more information.


We have 2 further currently planned for 2017 as follows:-

  • Informed participation and patient empowerment: a patient-centred approach to improve paediatric clinical research by Mariangela Lupo on Wed, 27th Sep 2017
  • EU Clinical Trial Regulation 536/2014: Safety Reporting OR New Transparency Rules to be presented by Dagmar Chase on Wednesday 11th October 2017;

Each of the above will be open to non-members with an associated fee of 90 EUR (EUCROF Members 60 EUR).


[Back to e-News May 2017]


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