eNews January 2019

18 February 2019 Newsletters Leave a comment 2081 Views Leave review

Dear Members, Associate Members, Partners and All,

Together with the EUCROF Board, I am very happy to present our first EUCROF Newsletter of 2019, reviewing activities in the period October to December 2018 and looking ahead at what is planned in early 2019.

Since the last eNews in October 2018, EUCROF and its members have been involved in numerous activities and initiatives. We held our General Assembly in London, which was attended by a record number of members. It was excellent to see so many attendees be present and ensured the meeting covered many of the key topics EUCROF is focused on at this time, including setting out our objectives for 2019. My sincere thanks to the United Kingdom association, CCRA, for their preparations and hospitality, which made the General Assembly such a resounding success. My thanks to the CCRA Member Company, Quotient Sciences, who supported the Social Dinner.

We continued to be involved with activities at the EMA, most notably the onsite testing of the Clinical Trial Information System, which is an important pre-requisite for the implementation of the EU Clinical Trial Regulation. The next phase of testing, as part of UAT7, has been delayed from January 2019 until a future date to be confirmed, so that it is now expected the EU CTR will be implemented until later in 2020. I will be attending the next stakeholder meeting with others from EUCROF on 20^th February, so hope to hear more positive news about next steps then.

Finally, work is gathering pace on preparations for our 5^th International Conference on Clinical Research in Amsterdam. Although it is not until 10&11 February 2020, we know that upfront hard work in planning and organising such an event is key to its success. My thanks to the members of both the Programme Committee and Organising Committee for their commitment and efforts in the coming months. The programme will be 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, medical devices, academia and patients contacts. Also, please, motivate your respective members to participate.

I wish you a successful 2019.

Martine Dehlinger-Kremer
EUCROF President

EUCROF NEWS AND EVENTS
FORTHCOMING EVENTS

General Assembly in London

EUCROF’s winter General Assembly (GA) took place on 6th and 7th December 2018 at the Park Plaza, County Hall, London, United Kingdom, hosted by the Clinical and Contract Research Association (CCRA), the national member from the UK. It was the best attended GA ever with 36 attendees present and with 4 others joining by telephone over the two days of the meeting. Attendees represented 17 countries: Albania, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Slovakia, Spain, Turkey, The Netherlands, United Kingdom, Ukraine, Algeria, Israel, and the Lebanon.

Following a welcome from Professor Atholl Johnston, President of CCRA and Dr Martine Dehlinger-Kremer, President of EUCROF, the agenda for the meeting covered a wide range of topics including:

Summary of EUCROF Board Activities 2017/2018 (Executive Board)
Provisional Financial Situation 2018 (Executive Board)
EUCROF Achievements for the last mandate – 2016/2018 (Executive Board)
Working Groups update (WG Chairs)
EU Data Protection Regulation: Code of Conduct (YMa)
Presentation of new EUCROF members (Sermes – Spain and Optimapharm - Croatia)
Vote for the EUCROF Executive Board (All)
Vote for the Finance Audit Committee (All)
EUCROF 2019/2020 Objectives and Priorities (Executive Board)
Proposal and vote for 2019 budget (YMa)
EUCROF Conference in Amsterdam 2020 – update (DHr/ MGa)
2nd Kiev Clinical Research Forum (SMy)
Presentation on SMOs in Ukraine (ATi)
eClinical Forum - Potential collaboration (YMa)
Location Proposal for GAs in 2019
Suggestions for new Working Groups (EB and FMB)
AOB & Conclusions

Of note was that at this GA there was an opportunity for Members to decide on more than 15 "action items", give 14 "votes" (including the 5 EB member positions). This means that the GA was successful in becoming more "decision-making" oriented, than just discussion, which has been a desire of EUCROF members over recent years.

Our sincere thanks go to the UK Association CCRA for hosting the event in London.

EU Clinical Trial Information System Update

As you all are aware, EUCROF has been involved in supporting the User Acceptance Testing of the EU Clinical Trial Information System (previously called the Clinical Trials Database and Portal), which has been in development over the last few years. EUCROF has provided both off-site and, more recently, on-site testers from our Members.

Further work involving our UAT Champion, Ingeborg Boddeke, including a preliminary user acceptance testing (pre-UAT) of CTIS Release 0.7, which took place on 5-13 November 2018. This pre-UAT brought together UAT Champions representing Member States and Sponsors with developers and business analysts. This gave an opportunity for business experts to complete end-to-end business scenarios and to discuss and clarify the findings directly on site with developers. This was a successful process and the EMA intend to build on this for its future development, ensuring input from users on prioritisation, design as well as testing of releases.

However, the EMA announced in December 2018 that at this time it became clear that the conditions needed for UAT7 to commence have not yet been reached. Release 0.7 therefore remains in a phase of pre-testing, while the EMA continues its work to fix the remaining bugs with the contractor and will implement improvements in Release 0.7 prior to user acceptance testing. The EMA noted that the project plan would be under revision to improve delivery and to ensure that stakeholders can give feedback more regularly during the process so that their expectations can be taken into account as early as possible.

Finally, based on the above, the EMA announced that the UAT7 would not take place in January 2019.

The next Stakeholder meeting will take place at the EMA in London on 20th February, when EUCROF representatives will be in attendance.

We will keep you all posted on future developments in this important area, but if you have any questions, please do not hesitate contacting Simon Lee at This email address is being protected from spambots. You need JavaScript enabled to view it.

Emerging Markets - Phases Conference in Prague

Our EUCROF colleague, Dr Darina Hrdličková from the Czech Republic, attended the Emerging Markets Phases Conference Prague last October where she gave 2 presentations as follows:

Presentation 1: Risk Based Monitoring Is Here to Stay

Development of monitoring from the 1990s, from 100% SDV and attention to detail to RBM
Increasing trial complexity and its influence on site and CRO teams
Principles of RBM
Feedback from sites

CLICK HERE to see the slides

Presentation 2: Sites in CEE. A reliable place for clinical research?

History of the clinical trial sites, and their motivation for clinical research
Major changes of sites 1990s-2018
Sites and remote monitoring – reactions, acceptance/non-acceptance
Risk Based Monitoring - ICH GCP E6 (R2) – what is it for sites
Trends for the future: growing teams, dedicated sites for clinical research, new approaches to patient enrolment

CLICK HERE to see the slides

The two day conference programme was as follows:

Day 1:

Keynote Presentation and Q&A: Streamlining the regulatory process
Conducting clinical trials across multiple regions: factors influencing regional differences and attractiveness
Spotlight sessions “Beyond the Borders Projects”.
Focus on Countries: Russia, Ukraine, Kazakhstan, Georgia

Day 2:

Spotlight on Turkey & MENA
Site Management
Spotlight on CEE & South Europe

GCP Inspection Readiness Conference

EUCROF had the pleasure and privilege to join a two-day event focussing ‘Inspection Readiness’ and the multiple dimensions pertinent to it. For example this included:

Aspects such as culture, internal processes and operating procedures, best practices, operational approaches (ranging from real life experience to mock inspections) to prepare for an inspection but also remain inspection ready for the duration of all clinical trials!
Maintaining a culture of readiness is one of the most complex challenges in successfully running and completing clinical trial studies. It covers multiple pillars essential to success such as management of TMFs, CAPAs, Quality Management Systems...
ICH GCP R2 and the Clinical Trial Regulation are adding new dimensions, the sponsorship oversight and some new transparency requirements; this was the subject (“Regulation Readiness”) covered by Michèle Garot, our EUCROF representative.

As always, speaker’s extensive experience, interaction between participants, sharing diverging perspectives have made this conference a great learning moment.

For more information contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it.

Brexit Survey

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 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.

As indicated in previous newsletters, the survey was sent out to EUCROF member associations who, in turn, sent the survey to their member CROs.

In total 67 surveys were completed and returned. The data is currently being analysed and will be presented at future Full Members’ Board meetings and in the next edition of the newsletter. By then, hopefully, the outcome of Brexit negotiations will be concluded in a way that protects Life Sciences and clinical trials across the UK and EU27 countries.

In the meantime, if you have any questions please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it..

Working Group Update

The Paediatric Working Group (PWG) set up a survey that has been distributed among EUCROF members and Associate members in order to investigate which topics can be of interest for CRAs in view of future paediatric training activities. One of the main aims of this working group in fact, is to increase knowledge related to paediatric clinical research as well as improve the paediatric research by collaborating with the different stakeholders, from regulatory authorities to pharmaceutical industry and patient advocacy groups.

112 answers have been collected from ten different countries. Most of the experts who responded to the survey showed high interest in CRA training specific to paediatric trials and in particular in the following topics:

Regulatory framework
Informed consent and assent process
Safety
Follow-up of children after end of trial

Further topics have been proposed as object of training such as the strategies to implement technology in clinical trials, ethics assessments and rare diseases involving paediatrics.

The Paediatric Working Group, chaired by Martine Dehlinger-Kremer, President of EUCROF, was founded in 2007 and is aimed to improve clinical research in children, to improve the relationships between the different stakeholders involved in paediatric research, i.e., industry, sites (networks), ethics, authorities, HTAs, and patients/patient advocacy groups and to sensibiliser society about the importance of paediatric research to obtain better medicines for children.

More information about the PWG can be found at this link: https://www.eucrof.eu/eucrof-about/working-groups-eucrof.

Industry News and Updates

EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.

The strategy will help to shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It seeks to offer informed guidance on modern medicines development, facilitate the optimisation of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

The five key goals of the strategy include:

catalysing the integration of science and technology in medicine development;
driving collaborative evidence generation - improving the scientific quality of evaluations;
advancing patient-centred access to medicines in partnership with healthcare systems (for human medicines only);
addressing emerging health threats;
enabling and leveraging research and innovation in regulatory science.

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.

You can find the draft of the document here.

EMA Consultations Update

The EMA launched a number of consultations during the last 3 months and if you wish to participate and provide feedback please click the link(s) below as appropriate.

The European Medicines Agency has released for public consultation a draft qualification opinion on eSource Direct Data Capture (DDC).

Comments should be provided by 14 March 2019.

CLICK HERE for more information

A Consultation: ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines

Comments should be provided by 24 March 2019.

CLICK HERE for more information

The European Medicines Agency has released for public consultation a concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury.

Comments should be provided to the EMA by 31st March 2019.

CLICK HERE for more information

The European Medicines Agency has released a concept paper on a guideline for allergen products development in moderate to low-sized study populations.