eNews April 2018

Dear Members, Associate Members, Partners and All,

 

Together with the EUCROF Board, I am very happy to present our second EUCROF Newsletter of 2018, reviewing activities in the period January to March 2018 and looking ahead at what is planned in the coming months.

Since our last eNews in January 2018, EUCROF and its members have been involved in numerous activities and initiatives. One of the most significant was the 4th International Conference on Clinical Research which was held in Vienna on 24 and 25th February 2018. I am pleased to inform you that, after much effort by all those involved, the Conference was a success. As with previous conferences, we had an excellent programme of presentations by experts in their field and it was well attended. My thanks to my colleagues who were involved in the Programme and Organisation Committees, together with others who all made this Conference a success. My thanks to all the EUCROF members who attended. That said, we always learn from our conferences and will strive to ensure our next conference in Amsterdam in 2020 is even better.

 

With regard to the Conference in Amsterdam, although the dates are still to be fixed, we have already started to make plans in conjunction with ACRON, the Dutch Association and BeCRO, the Belgian Association, who are also collaborating with us on this event. Most notable is that it will mark the 25thanniversary of ACRON, the 15th of EUCROF and the 10th of BeCRO, so it will be an exciting celebration of our associations.

Our collaboration with the EMA continues to be strong with our continued participation in the UAT for the clinical trial portal and database, plus meetings associated with paediatrics and pharmacovigilance, each of which are important initiatives for our industry. My thanks to all those involved.

I am pleased to say that we now have a video on You Tube, providing an introduction to EUCROF and its activities with more to follow and our new website is ready to be launched during May. My thanks to Christophe Golenvaux and the other members of the Communication Working Group for their significant efforts in developing the new site.

 

This year has started well and continues our successes seen in recent years. Thank you in advance for your continued contribution to our success.

 

In the meantime, I wish you a happy reading.

Martine Dehlinger-Kremer

EUCROF held its 4th European Conference in Vienna, from 26th to 27th February 2018. The venue was the Austria Trend Hotel Conference Facility, Olympia Mancini Hall.

The Conference had an extensive programme of presentations covering many key topics facing our industry today, all being presented by leading speakers on each topic. Feedback from those members who attended was that overall the meeting and the content was very beneficial and informative.

 

Our sincere thanks to members of both the Programme and Organising Committees together with C-IN plus all others involved in making this Conference a success.

 

Attention is now already switched to our next Conference planned in Amsterdam in 2020.

This important Working Group has been re-established with a new chair and is now looking for new members. Nikki Doyle of CCRA, the UK national association, is the new Chair of the WG. Nikki has worked in the clinical development field for more than 10 years and, at present, is working for a CRO, Clinical Professionals, in the UK.

The Education & Training Working Group will undertake the coordination of training provision for the membership of EUCROF. Nikki’s proposal is that this would involve producing material which could be used as standalone training vehicles, as well as providing a comprehensive medium to train new members of staff. Additionally, the aim of the Working Group would be to encourage collaborations and exchanges of expertise, as well as promote and nurture relationships between members to support the impact of EUCROF as an international body.

 

In order to accomplish these objectives, the Working Group proposes to:

  • Create online monthly hot news summary
  • Coordinate and produce quarterly webinars featuring EUCROF members or external collaborators with expertise
  • Facilitate the opportunity for ongoing feedback to enable the exchange of best practices and to suggest training ideas
  • Create a factsheet library
  • Online area for people to recommend external training courses they have been on
  • Encourage and promote opportunities for mentorships

 

The Working Group would also ensure that the training provisions of applicable regulatory agencies of each member country were also promoted and signposted.

Encouragement would be given for all members to be animated and engaged and suggest topics which they may find useful to learn more about. This would aid and shape the training provided to be appropriate and beneficial to all.

If you are interested to find out more and maybe join the EPWG please see invitation letter HERE and contact Nikki Doyle via email at  or Assia Rosati via email at .

 

Finally, other EUCROF working groups recently re-established and looking for new members are the

  • Early Phase WG and
  • Innovative Medicines WG.

 

If you are interested in becoming an active member of either of these new WGs please contact Simon Hutchings directly via email at  (for the Early Phase WG) and Astrid Pañeda Rodriguez (for the Innovative Medicines WG), throughAssia Rosati via email at  respectively.

The Communication WG, chaired by Christophe Golenvaux, have been working hard to upgrade EUCROF’s website. Significant progress has been made and it is now ready for launch by the end of May. The EUCROF Executive Board sees this as an important tool in the communication with Members and the wider industry.

 

You will soon see that the website has a fresh look and added functionality, more in line with current practices, which we hope will be well received by Members and others visiting the site in due course.

 

In the meantime for more information please contact Christophe Golenvaux ( ).

As you are aware from the last newsletter, EUCROF was accepted onto the EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Working Group 2 “Independence and Transparency” through membership of our colleagues Dagmar Chase, Denis Comet and Dr Xavier Fournie. We have subsequently provided important input into the Code of Conduct Revision 4. (EMA/929209/2011), which has been submitted to the EMA for consideration.

 

This is a significant initiative for EUCROF and its Members to be involved in and, if you are interested in hearing more about it, please contact EUCROF’s representative, Xavier Fournie directly via email at 

The Clinical Trial Legislation Working Group provided comments to the EMA 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”

 

Comments were sent into the EMA in February and thank you to those statisticians amongst our Members, who helped with the review of the Guideline.

 

If you are interested in hearing more details please contact Dagmar Chase, Chair of the WG, at  .

EUCROF’s President, Martine Dehlinger-Kremer, is Chair of the Paediatric Working Group and is a specialist in this area. To this end, Martine was invited to present and chair various sessions at a number of conferences at the end of 2017 as follows:-

  • EMA/EC multi-stakeholder workshop to further improve the implementation of the paediatric regulation on 20 March 2018.

 

If you are interested to hear more, please contact Martine Dehlinger-Kremer via email at  .

EUCROF’s Vice-President, Dr Stefano Marini, a specialist in the field of clinical and medical research, presented on behalf of EUCROF at various conferences as follows:-

  • Clinical Research between New Rules and Personalized Medicine: quo vadis? - Italian Oncological Group of Clinical Research in Rome on 23 March 2018.

 

For further information please contact Assia Rosati at  or Stefano Marini at .

 

Dr Xavier Fournie, co-chair of the Pharmacovigilance WG, was invited to attend on behalf of EUCROF the following meeting at the EMA:-

  • EMA/13th Pharmacovigilance Stakeholder Meeting on 20 March 2018.

 

For more information please contact EUCROF’s representative, Xavier Fournie directly via email at  or Assia Rosati via email on .

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Coordinating Group has agreed to include EUCROF’s President, Martine Dehlinger-Kremer as an observing member in the Enpr-EMA Coordinating Group given Martine’s role as Chair of the Paediatric Working party of EUCROF and her significant experience in this area of clinical research. As per mandate of Enpr-EMA’s Coordinating Group, Industry representatives are invited to the annual workshops of Enpr-EMA and to attend CG meetings as observers on ad-hoc basis, to discuss selected topics. Observers have the right to speak, but not to vote.

The Coordinating Group is the operational centre of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). It consists of 20 Members (2 PDCO, 18 from recognized networks).

 

The group is responsible for the network's long- and short-term strategy. Its tasks include:

  • facilitating access of the pharmaceutical industry to paediatric clinical study centers and experts;
  • identifying new networks to include in Enpr-EMA;
  • developing common educational tools for children and parents, to increase their willingness to take part in clinical trials.

 

For more information click

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/11/WC500135694.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/02/WC500123157.pdf

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.

 

Information has been sent to all our member associations so we hope you have this date in your calendar. We are looking forward to seeing you all in Bratislava!

We are also working with our UK member association, CCRA to hold our full end of year General on the 6th and 7th of December in London.

More details will be sent out to Members in the coming month, but for now hold these dates in your diary.

 

In the meantime, if you have any questions, please contact Assia Rosati via email on  .

The focus of this meeting in London on 25th April was the ongoing development of the EU CT Portal and Database and was 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.

 

The next UAT7 is scheduled to take place in October 2018 over a period of 2 weeks and will be the last opportunity prior to the audit of the portal and database to participate in any testing.

The EMA has asked for testers from stakeholders such as EUCROF who have been previously involved in UATs and I am pleased to announce that Ingeborg Boddeke who has participated throughout, including UAT6 will be EUCROF’s lead tester with Aneta Wojtczak and Lidya Dominguez Burgo both as reserves. Our thanks in advance.

 

EUCROF representatives will also be participating in the off-site testing as well, which will occur at a similar time as the on-site testing.

 

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  .

Following discussion at the General Assembly in Madrid last November, the Full Member Board approved the initiative to establish a Code of Conduct for CROs for the forthcoming European General Data Protection Regulation, due to be implemented on 25 May 2018.

The initiative, led by the New Technologies Working Group, has written to CNIL (The French Data Protection Agency) requesting a meeting to discuss potential future collaboration with the preparation of and ultimate endorsement of the Code of Conduct. We have subsequently received a positive response and an initial meeting will be arranged in the coming months.

 

For more information contact Yoani Matsakis by email at  or Assia Rosati via email on .

With the impending departure of the United Kingdom from the European Union on 29 March 2019 there is a great deal of uncertainty and unanswered questions around the potential impact on both the Life Sciences industry both for the UK as well as the EU27. More specifically, what will it mean for the authorisation and movement of both marketed products and investigational medicinal products, together with aspects such as Legal Representative, Qualified Persons and PVQPs.

After discussion at recent Board meetings, it is intended to send out a survey to our Members to ascertain your views on the topic and understand more any impact and subsequent actions.

 

The survey will be sent out in May but, in the meantime, if you have any questions please contact Assia Rosati via email on 

There is interest within the EUCROF membership to establish two new Working Groups in Patient Associations and Geriatrics. The former has a chair and currently 5 members with other welcome to join. It will focus on identifying best practice to connect patients involved in clinical trials.

There is interest in establishing a WG in the area of Geriatrics which is becoming an area of increasing interest. At this time there is no person who wishes to chair and establish the WG, so please give this some thought and let us know if you are interested.

For further information on either of the above please contact Assia Rosati on 

We continue to be invited to represent EUCROF at major events and meetings across Europe in the coming months.

Our EUCROF colleague Alan Yeoman of the New Technologies Working Group will be attending the meeting at the EMA: “Workshop with interested parties on topics related to (electronic) archiving of study data and related subjects”.

 

Our Vice President, Dr Stefano Marini has also been invited to present on the "Status of advancement of the EU Clinical Trial Regulation and the Portal (S. Marini - guest speaker)" at the 3rd Annual Clinical Trials Quality & Compliance in Vienna in September 2018.