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Published: 20 December 2016

Dr. Stefano Marini, invited speaker at CCRA Seminar “UK Clinical Research – A Professional Awareness Update & The Future of Clinical Research Post-Brexit” London, 24th/25th January 2017

 

Dr. Stefano Marini, EUCROF’s Vice-President, has been invited to present on day two of this seminar being held by our UK members CCRA. The seminar will bring together key stakeholders from Government, Department of Health, regulators, industry experts and the wider community of UK healthcare professionals to deliver unique insights and a roadmap for the continued success of the UK domestic industry. Day two will look at The Landscape of Clinical research Post Brexit, taking a deeper dive into the opportunities and challenges facing the industry in a post Brexit Britain. Dr. Marini’s presentation will provide a view from Europe on this topic.

For further information or to book a place please visit www.ccra.org.uk

 

 
Published: 20 December 2016

The 6th Clinical Research Day organized by AFCROs will take place in the salons of Le Méridien Etoile on 26 January 2017.

 

 

This event is the meeting place for all stakeholders, professionals and actors in Clinical and Epidemiological Research: institutional, academic, industrial products Health, Cosmetics and Nutrition, CROs, patients and service providers and test support. The day will begin with thematic workshops where the stakeholders of Clinical Research and Monitoring will be invited to exchange, debate and propose ideas around the themes of everyday practice. The afternoon will encourage meetings between professionals and conference attendees.

For further information or to book a place please visit www.afcros.com

 

 
Published: 07 December 2016

EUCROF has a new executive board

 

Following elections at last week’s General Assembly in Munich, EUCROF is very pleased to announce the new Executive Board members for the next two years. 

Dr. Martine Dehlinger-Kremer was elected to the position of President replacing Dr. Stefano Marini, who could not stand again having served the permitted three mandates as President. Dr. Stefano Marini was elected as Vice-President and will continue to be actively involved with the Executive Board. Yoani Matsakis and Christophe Golenvaux were both re-elected to the Executive Board as Treasurer and Board Member respectively. Simon Lee was elected for the first time to the position of Secretary. The new Executive Board with immediate effect is thus as follows:-

Dr. Martine Dehlinger-Kremer – President

Dr. Stefano Marini – Vice-President                                     

Simon Lee – Secretary

Yoani Matsakis – Treasurer

Christophe Golenvaux – Member

The Executive Board on behalf of EUCROF’s members wish to thank Darina Hrdlickova who has been a member of the EUCROF Board in the position of Secretary since 2012. Darina’s support of the EUCROF conference in Prague has been key to its success. 

These elections were significant in that they saw the end of a long association of Dagmar Chase who was one of the founding members of EUCROF. Dagmar took the decision to step down as Vice-President and no longer stand for an Executive Board position after serving the Board for 11 years. The Executive Board on behalf of EUCROF’s members wish to extend its sincere thanks to Dagmar for her unwavering commitment toward the EUCROF cause and her many achievements during her tenure. However, we are pleased that Dagmar will continue to be involved in EUCROF activities including Chair of the Clinical Trial Legislation Working Group.

Finally our sincere thanks also goes to Stefano Marini who participated to the founding of EUCROF in 2005 and led EUCROF as President for the last 6 years and, together with Dagmar Chase, has successfully established EUCROF into one of the leading associations of its type in Europe, recognised by key stakeholders in the Pharmaceutical Industry, as well as by Regulatory Authorities.  

 

“I am honored to be entrusted by EUCROF members with this election as President,” said Dehlinger-Kremer. “I look forward to working with the board to further the Federation’s vision as a key institution in contributing to the development of better medicines for patients through CRO knowledge and expertise. We will collaborate with authorities, partner with pharma and patient associations, and expand the training role for CROs to further EUCROF’s mission.”

 

“I am glad that Martine Dehlinger-Kremer has been elected as new EUCROF President as I am sure she will act with the needed passion and competence and wish all possible success to the new Executive Board” said Marini.

 

For further information please contact the Secretary and/or President via email on

This email address is being protected from spambots. You need JavaScript enabled to view it.  and/or This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 
Published: 16 September 2016

Consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products Conducted with Minors”: a response from Enpr-EMA and partners

 

 Download full reportpdf

Enpr EMA

Introduction

The EU Clinical Trials Regulation 2014 (CTRs) offers a great opportunity to improve research involving children.  The supporting document "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" is crucial to its implementation and achieving the Regulations’ aims to facilitate research and promote the health of our children and young people (minors).

This document represents the response from Enpr-EMA, its working groups (including representatives of networks, National Competent Authorities and pharmaceutical industry), and partners. It was led and drawn up by Hugh Davies (European Forum for Good Clinical Practice), Pirkko Lepola (Finnish Investigators Network for Pediatric Medicines, chair Enpr-EMA working group on Ethics) and Martine Dehlinger-Kremer (chair paediatric working group of EUCROF and member of EFGCP Children Working Party); then circulated to Enpr-EMA members and partners for their comments.

It is in two parts:

Part 1: General comments on guidance layout and content

Part 2:  Specific comment on the text in the guidance with recommendations at the end of each

Executive summary

  1. This document must be written for all audiences, researchers, regulators, research ethic committees, but more importantly families and children.
  2. To improve readability, use of modern technology would allow the text to be layered providing easier reading and increasing detail.
  3. This guidance should
    • be built around text from the regulations in each section
    • offer advice on the interpretation of the regulations.
    • seek and include evidence and practical examples wherever possible (we have tried to add some) .
    • call for more research
  1. This guidance could profitably be built around “Principles underpinning ethical conduct of CTIMPS involving minors”.
    • Children have vulnerabilities both as research participants and as recipients of unresearched care so fair balance must be struck between the two.
    • Minors (children, young people and their families) should be involved in research from inception, in its design and the material to be used.
    • Research involving minors must be preceded by careful risk assessment (benefits and harms) and then management.
    • The arrangements for consent, assent and recognising dissent require specific consideration in clinical trials involving minors.
    • Extrapolation of adult data is possible but this must be done with due care.
    • Those conducting research involving minors should have appropriate expertise.
    • Those reviewing research involving minors should have appropriate expertise.
    • Openness and transparency are important parts of ethical research.

 

Download full reportpdf

 
Published: 11 April 2016

Dr. Stefano Marini, EUCROF President, is an invited speaker at the conference “The Annual Meeting of the Clinical Trials Community in Israel” taking place in Tel Aviv on April 11th. The title of his presentation is “Is it Still Worth Working for a CRO?” (http://bioforumconf.com/english-ctrials2016).

 

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