eNews January 2017

Dear Members, Associate Members, Partners and All,

 

Together with the EUCROF Board, I am very happy to introduce our first EUCROF e-News newsletter produced by the new Executive Board. The newsletter will allow us to share important information, news, events and celebrate successes. The newsletter is ours and every one of you is invited to contribute. Please use it as your forum for communication.

In November 2016, a new Board was elected (see link below). I am excited about being elected President of EUCROF and look forward to working with the board and all Members and Associate Members to further the Federation. EUCROF is already a key stakeholder for authorities in contributing to the development of better medicines for patients through CRO knowledge and expertise. The success of EUCROF is, first of all, the success of its Members and Associate Members, and the great example of the power of cooperation they demonstrate in their everyday commitment to its achievements. I look forward to ensuring its continued success and further growth.


In particular, I anticipate expanding EUCROF’s role with stakeholders and its participation geographically, as well as advancing the role and knowledge of CROs, as they are increasingly looked to by sponsors to improve and advance clinical trials. I believe further collaboration is important, and would like to see EUCROF become a key partner for pharmaceutical associations and authorities, contribute to the set-up of European initiatives such as the Pan European Paediatric Network funded by IMI2.  I look forward to greater involvement with patient organizations, with patients becoming more involved in clinical research and increasingly being consulted by authorities such as the EMA and pharma companies.


Additionally, I anticipate capitalizing on EUCROF’s willingness to expand in the larger EU geographical territory and neighbourhood, an expansion that has been formally endorsed by the approval of the new bylaws, as well as expanding to other non-EU countries and developing increased relationship with equivalent or sister organizations. First steps in that direction have already been taken, with Turkey, Ukraine and Israel having joined EUCROF. This is a logical step as drug development is increasingly a global initiative. I also aim at increasing awareness of EUCROF overall and of its robust knowledge, training systems and resources, some of which are now open to individuals outside of its membership, on a worldwide dimension.


I look forward to working with all of you. I wish you a happy reading.


Martine Dehlinger-Kremer

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 is thus as follows:

EUCROF executive board

On behalf of EUCROF’s Members, the Executive Board wishes 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. On behalf of EUCROF’s Members, the Executive Board wishes 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 (as well as member of the Programme Committee for the Eucrof Conference in 2018).

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. Together with Dagmar Chase, he 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  or   and/or   or 

EUCROF has long established Working Groups (WGs) in the following areas:

Clinical Trial Legislation – Chaired by Dagmar Chase; 

Communication  - Christophe Golenvaux; 

Early Phase - Keith Berelowitz; 

Education & Training (incl. Webinars) - Antoinette Van Dijk; 

Late Phase - Denis Comet; 

Medical Devices - Antoinette van Dijk; 

Paediatric - Martine Dehlinger-Kremer; 

New Technologies – Alan Yeomans  and Yoani Matsakis; 

Outsourcing Management - Philippe Van der Hofstadt; 

Pharmacovigilance - Nicolas Tsiakkas; 

If you are interested in participating or hearing more about any of the WGs, please contact the chair directly using the email address provided.  In future editions we will provide you with updates on the activities and accomplishments of each of the WGs.

Over a number of years EUCROF had held educational webinars to help disseminate information about important topics relevant to our CRO industry. Last year we successfully held 4 webinars and we plan to surpass this number with 4 webinars currently scheduled more in the schedule.

 

So far these include:

  • Impact for Good Pharmacovigilance Practices (GVP) Regulation on Non-Interventional Studies to be  presented by Dana Vankova on Wednesday March 15th;
  • EU Clinical Trial Regulation 536/2014: Informed Consent Procedure to be presented by Dagmar Chase on Wednesday 10th May 2017;
  • Extrapolation approach in paediatric clinical research: chances and bottlenecks to be presented by Lucia Ruggieri on Tuesday 13th June 2017;
  • Informed participation and patient empowerment: a patient-centred approach to improve paediatric clinical research to be presented by Mariangela Lupo on Wednesday 27th September 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) 

IMI2 have launched Call 10 which includes the topic on a Pan-European Paediatric Trials Network.

https://www.imi.europa.eu/content/imi-2-call-10

 

Please read about the call text below: we are interested in Topic 4 starting on page 56.

https://www.imi.europa.eu/sites/default/files/uploads/documents/IMI2Call10/IMI2_Call10_TopicsText.pdf

 

A member of our Pediatric Working Group (Mark Turner) is leading the development of an applicant consortium for this Topic. To his knowledge this is so far the only applicant consortium.

Mark Turner is keen to include CROs in its consortium through a mechanism that allows a single organization to represent all CROs, both large and small. Of course, members of individual CROs will be able to contribute to specific tasks. However, there will be no favour of any individual provider (profit or non-profit) in this pre-competitive project.

There have already been discussions on the roles CROs can play in an applicant consortium with the final proposal to the IMI, scheduled for the end of March.

 

We will keep you posted on developments in this important initiative. 

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6 (R2).

 

The reflection paper is available for download via the following link: Reflection paper on GCP Renovation

This meeting was established to discuss stakeholder concerns regarding the User Management aspects of the Clinical Trial Portal and database currently being developed by the EMA. Dr Stefano Marini and Simon Lee attended the meeting on behalf of EUCROF and gave a joint presentation to the meeting with EUFEMED. The presentations provided by all stakeholders were well received by the EMA and discussions were very productive.  

EUCROF representatives, along with other stakeholder groups, participated in the fourth User Acceptance Testing of the EU CT Portal and Data base. EUCROF now has over 50 testers involved from over 10 member countries which is excellent news. Through this participation we are making a significant contribution to the development of the CT portal and database. 

Our member association in the United Kingdom – Contract & Clinical Research Association (CCRA) held its annual ‘Clinical Research – A professional Awareness Day and the Future of Clinical Research Post Brexit’ on 24th and 25th January. Dr Stefano Marini was invited to attend and presented on behalf of EUCROF. For further information please visit www.ccra.org.uk


Our French association AFCROs organised this annual event to take place in the salons of Le Méridien Etoile on 26th January 2017. Once again our Vice President, Dr Stefano Marini, was invited to attend and presented on behalf of EUCROF. For further information please visit www.afcros.com.

The specific date has not been released by the EMA CT team yet, but it is expected to take place during the next few months. Simon Lee will continue as Focal Point coordinating the activities of EUCROF testers. If you are interested in becoming a tester please don’t hesitate to contact Simon immediately at  or 

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), Simon Lee (Secretary) and Dagmar Chase. This is the first of two meetings scheduled to take place in 2017, the second in September, to discuss this important topic ahead of the implementation of the European Clinical Trials Regulation in October 2018. 

EUCROF has been asked to provide experts to attend a workshop to be held at the EMA offices in London on March 28th.  The focus of the day will be to review the practical aspects of the forthcoming revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ (EMEA/CHMP/SWP/28367/07). EUCROF will be represented by Dr Stefano Marini (Vice President) and Dr Stuart Mair (Medical Director at Quotient Clinical, a member of CCRA in the UK).

The EFGCP Annual Conference will take place in Brussels, Belgium on 21th& 22nd February 2017 at the Diamant Conference Centre. The title of the Conference is “Meeting the Ethical Standards under the Clinical Trials Regulation – the burning questions (and answers) for Researchers, Sponsors and Patients”

For more information visit www.efgcp.eu

The conference will take place at Kensington Conference and Events Centre, London, UK from 18th – 19th May 2017, preceded by a pre-conference workshop on 17th May 2017.


An excellent programme has been compiled with world renowned experts in human pharmacology presenting a wide range of highly topical issues. The theme of the conference is exploratory medicines development: innovation and risk management with an emphasis on interactive and inter-disciplinary discussion which we hope will be lively and thought provoking.

Please put the date in your diary and join us in London! Enquiries to the Conference Secretariat: The Conference Collective Ltd, 8 Waldegrave Road, Teddington, Middlesex, TW11 8HT, UK.

Tel 44 (0) 208977 7997 Email: