eNews January 2018

Dear Members, Associate Members, Partners and All,

 

Together with the EUCROF Board, I am very happy to present our first EUCROF Newsletter of 2018, reviewing activities in the period October to December 2017 and looking ahead at what is planned in early 2018.

Since the last eNews in October 2017, EUCROF and its members have been involved in numerous activities and initiatives. We held our General Assembly in Madrid which was attended by a record number of members, which was excellent to see and ensured the meeting covered many of the key topics EUCROF is focused on at this time, including setting out our objectives for 2018. My sincere thanks to the Spanish association, AECIC, for their preparations and hospitality which made the General Assembly such a resounding success.


We continued to be involved with activities at the EMA most notably the onsite testing of the Clinical Trial Portal and Database (UAT6) which took place in November and relied on the participation of members Ingeborg Boddeke from The Netherlands and Lidya Dominguez from Spain. My thanks to them both and their associations and companies for supporting this important activity.


Finally our 4th International Conference on Clinical Research in Vienna is now less than a month away. Previous conferences have been successful and contributed to our members’ skills and experience in clinical research. The programme this year is even stronger in content, with many excellent speakers involved. You have all excellent relations with industry. We would appreciate your personal involvement in the promotion of the conference amongst your pharma, biotech and medical devices contacts. Also, please, motivate your respective members to participate. We count on your support to make the conference a success. I look forward to hopefully seeing you there.


I am looking forward to a successful year 2018. Thank you in advance for your contribution.

In the meantime I wish you a happy reading.


Martine Dehlinger-Kremer

EUCROF’s Winter General Assembly took place on 21-22 November 2017 at the Holiday Inn Alcalá, in Madrid, Spain. It was probably the best attended GA ever, with 23 attendees present and with 2 others joining by telephone over the two days of the meeting. Attendees represented Albania, Belgium, Czech Republic, France, Germany, Greece, Italy, Slovakia, Spain, Sweden, Turkey, The Netherlands, United Kingdom, Ukraine, Algeria, Israel, and the Lebanon.

The agenda for the meeting covered a wide range of topics including:

  • Summary of EUCROF Board Activities 2016/2017 (Executive Board)
  • Financial Report 2016 – Provisional Financial Situation 2017 (Executive Board)
  • Working Groups update
  • EUCROF Survey – results, comparisons & comments (CGo)
  • Presentation of new EUCROF members
  • EUCROF Conference in Vienna 2018 – update
  • 1st Kiev Clinical Research Forum (MDK)
  • AECIC – EUCROF Meeting
  • EUCROF 2018 Objectives and Priorities (Executive Board)
  • Budget Projection 2018 (Executive Board)
  • Guidance Document for Conferences (MGa (TC)/ DHr)
  • EUCROF Website Upgrade (CGo)
  • Location proposal for GA in 2018
  • Identification of location for the next EUCROF Conference (DHr)
  • EU Data Protection Regulation: Code for Conduct (YMa)
  • Patient/Patient Associations Relation (Executive Board)
  • Suggestions for new Working Groups (EB and FMB)
  • AOB & Conclusions

 

The minutes from the GA can be found here .

Our sincere thanks goes to the Spanish Association, AECIC, for hosting the event in Madrid.

As you know from previous communications, EUCROF will be holding its 4th European Conference in Vienna, from 26th to 27th February 2018.

The venue will be the Austria Trend Hotel Conference Facility, Olympia Mancini Hall.

With less than a month to go before this exciting Conference, there is still time to book your place on line by clicking here to link to the Conference website!!

The Conference has a programme of presentations covering many key topics facing our industry today, all being presented by leading speakers on each topic. As with our previous conferences, we are sure participants will find the meeting and the content to be very beneficial and informative.

 

As requested in our President’s introduction to this Newsletter, please make every effort to invite as many as possible of your contacts to the conference

 

For further details please contact Darina Hrdličková at  (Chair of the Organising Committee) and Michèle Garot,  (Chair of the Programme Committee).

This important Working Group has been re-established and is looking for new members. Simon Hutchings of CCRA, the UK national association, is the new Chair of the WG and presented his ideas for the WG activities at the General Assembly in Madrid. Simon has worked in the clinical development field for more than 10 years and, at present, is working for a CRO in the UK. In his opinion, the opportunity is the challenge of an effective implementation of Early Phase work. There is a high level of interest from the US in the EU and in its expertise in this early phase arena, which was emphasised by the recent introduction of the First into Human Guidance. The WG will look at ways of helping EUCROF’s members working in the early phase to exploit this as much as possible.

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

Finally, EUCROF’s recently established WG focused on Innovative Medicines is still looking for new members. If you are interested in becoming an active member of this new WG please contact Astrid Pañeda Rodriguez directly via email at .

The Communication WG, chaired by Christophe Golenvaux, is working toward upgrading EUCROF’s website. The current website has been in place for some years and is in need of revamping to make it more modern, attractive, responsive and user-friendly. The EUCROF Executive Board sees this as an important tool in the communication with Members and the wider industry.

There is also a desire to have more videos (WG activities or teasers for webinars promotion), access and management of webinar recordings (paying or not). Furthermore there is an objective to create a EUCROF YouTube Channel to centralize videos and webinar recordings (private hosting enabled).

The new website should be available by end of Q1 2018.

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

As previously informed, EUCROF was invited to provide testers for the first on site UAT of the EU Clinical Trial Portal and Database to take place at the EMA’s offices in London. UAT6 took place from Monday 6 November to Friday 10 November 2017 (5 days) and EUCROF was represented by Ingeborg Boddeke of the Dutch association ACRON and GCP Central in The Netherlands and Lidya Dominguez of the Spanish association AECIC and the SERMES CRO in Spain.

Both found the testing to be very productive and worthwhile and they prepared slides to summarise their experiences whilst on site participating in this UAT – CLICK HERE to see the slides.

Our thanks go to both Ingeborg and Lidya for their personal time and commitment, which is very much appreciated by the EUCROF Board and members.

The next UAT7 is planned for early 2018, but dates are to be confirmed. EUCROF plans to have 2 more testers involved once again.

Simon Lee, EUCROF Secretary, will continue as Focal Point, coordinating the activities of EUCROF testers. If you have any queries, please don’t hesitate to contact Simon immediately at  as well as .

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:

  • DIA/EFGCP/EMA Conference on ‘How to Optimise Children’s Access to Innovative Medicines’ in London (EMA), 16-17 October 2017, where she was Member of the Programme Committee and chaired a session on Challenges for Paediatric Developments.
  • Paediatric Conference Eastern Europe in Budapest, Hungary on 14 – 15 November 2017, where she presented on “ The new Clinical Trials Regulation in the context of Paediatric Research”

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:

  • Course on “How is a Drug Developed: from the Preclinical Trials on Animals to Pharmacovigilance" in Rome, Italy on 9 October 2017 presenting on “Clinical Trials and the Typology of the Studies; Ethics Committee; Conflict of Interests; Publishing of Results”.
  • A meeting on 16 November, again in Rome, to discuss “How to improve Clinical Research in Italy: Time of Action” where he presented a ‘Comparison of the Various Aspects at an International Level’.

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

From 9 to 10 November 2017, PHARMASICH CRO - with the support of the EUCROF Board and members - held its first Clinical Research Forum in Kiev, Ukraine.

The Forum was a unique discussing platform for clinical research industry in Eastern Europe and was a great success with very interactive participants, as well as excellent presentations. In the end there were 47 speakers, 50 presentations and more than 250 attendees.

EUCROF had several representatives presenting at the conference: Martine Dehlinger-Kremer, Stefano Marini, Yoani Matsakis, Dagmar Chase, Michèle Garot, Philippe Van der Hofstadt and Xavier Fournie.  

Congratulations to contact, Dr Sergii Myronenko, and everyone else involved for making this Conference such a success.

The next Kiev Conference will be in Spring 2019.

For more information please contact Dr Sergii Myronenko at .

Clinical Trials Legislation Working Group (CTL WG)

Accomplishments in 2017

The CTL WG currently comprises 7 members out of 4 countries: Germany, UK, Spain and Greece.

We started our work in 2017 by submitting comments to the EMA “First-in-Human and Early Clinical Trials” Guideline. Thanks to our two members from the UK, who are both focused on early phase clinical trials, we were able to launch comments not only on behalf of the CTL WG, but also on behalf of the Early Phase WG. Two is better than one! The final Guideline will be in effect as of February 1st, 2018.

Our next mission was a small, but important one. In January 2017, the GCP Renovation Reflection Paper was issued. This came as a surprise, as the ICH-GCP Addendum (R2) had just been finalized in November 2016. Our WG took the opportunity to re-iterate that there are a number of issues in the original text of ICH-GCP (which has not been touched in R2), be it that the wording is not up-to-date (e.g. the term “Reference Safety Information” is not mentioned in the context of the IB), or be it that responsibilities are not mirroring reality (e.g. exclusive responsibility of EC submission lies with the investigator). The stipulated objectives of the GCP Renovation project, however, are to re-visit study designs and widen the scope for drug development, beyond the classical randomized controlled trial (RCT). This is planned in a revision of ICH E8. A lot of important data can be obtained through real world data approaches, for example, extraction of data from registries. However, if such data are used in the context of drug development (e.g. for comparator groups), then they have to meet certain quality standards. “Critical to Quality (CTQ)” factors need to be defined. This is the goal of the next revision of ICH E6.

A lot of work was put into the comments regarding the EMA Guideline for TMF/eTMF. This is a most relevant topic and not easy to handle, given the fragmentation of TMFs, the fact that usually there is a combination of paper and electronic records and – last but not least – the future required retention period of 25 years. In a total of 4 TCs, we came up with 18 pages of comments. The Guideline is not finalized yet.

The 4th topic we handled in our WG was the EMA Guideline on Serious Breaches of the EU Regulation 536/2014 or the trial protocol. As this topic is already part of the UK legislation today, it was no surprise that 1) the new draft shows some similarities to the UK Statutory Instrument and 2) the topic was already quite familiar to us. Nevertheless, there were a couple of important comments to make. We considered the question: is there a difference between a GCP breach and a breach of the Regulation 536/2014? These two types of breaches are mixed up in the document, without explaining whether they are meant to be synonymous or not.

I would like to thank all CTL WG members for their commitment and the time they dedicated to our WG. It has been a pleasure to work with you – let’s keep going!

Dagmar Chase, Chair of the CTL WG

Munich, January 2018

 

For more information contact Assia Rosati via email on .

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 .

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  or .

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…..

  • 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 .
  • 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 .

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 .