eNews January 2019

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 20th February, so hope to hear more positive news about next steps then.


Finally, work is gathering pace on preparations for our 5th 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’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.

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 simon.lee@quotientsciences.com

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

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 info@eucrof.eu

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 info@eucrof.eu.

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.

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.

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.

Comments should be provided to the EMA by 30 June 2019.

  • The European Medicines Agency has released for public consultation a draft concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease.

Comments should be provided to the EMA by 30 June 2019.

CLICK HERE for more information

  • The European Medicines Agency has released for public consultation a draft guideline on quality and equivalence of topical products.

Comments should be provided to the EMA by 30 June 2019.

CLICK HERE for more information

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 EMA is inviting all our stakeholders to send their comments via an online questionnaire by 30 June 2019.

CLICK HERE for more information

  • The European Medicines Agency has released for public consultation a Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease.

Comments should be provided to the EMA by 30 June 2019.

CLICK HERE for more information

  • The European Medicines Agency has released for public consultation a draft guideline on the non-clinical requirements for radiopharmaceuticals.

This guideline describes the non-clinical data that need to be submitted in relation to the non-radioactive part of radiopharmaceuticals, in the context of applications for marketing authorisations or clinical trials.

Comments should be provided to the EMA by 30 June 2019.

CLICK HERE for more information

  • The European Medicines Agency has released for public consultation a draft reflection paper on the qualification of non-genotoxic impurities.

Comments should be provided to the EMA by 30 September 2019.

CLICK HERE for more information

We are pleased to welcome a new Associate Member Partner to the EUCROF family, namely PCG Solutions, based in Sweden represented by Mats Klaar, CEO PCG Solutions, and Henrik Blombergsson, Co-founder & COO PCG Solutions.

 

PCG Solutions aims to change the way clinical trials are conducted. It is an EDC system that is powerful and easy to learn. It has been used in over 1200 trials in more than 70 countries in all therapeutic areas and clinical phases since 2003.

 

For more information visit: www.viedoc.com

With the help and support of our Czech Republic colleagues of ACRO-CZ, we are organising our next General Assembly in Prague, scheduled on Monday 3rd and Tuesday 4th June 2019.

More information will be sent to all our member associations in due course.

 

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

The focus of this meeting will be the ongoing development of the EU Clinical Trial Information System 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 2019. These meetings are to discuss this important topic ahead of the implementation of the European Clinical Trials Regulation in 2020. The focus is expected to be on what progress has been made on the issues identified during UAT6 and the pre-UAT 7 activities.

 

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 secretary@eucrof.eu or simon.lee@quotientsciences.com

As you know from previous communications, EUCROF will be holding its 5th European Conference from February 10-11, 2020 in Amsterdam. SAVE THE DATE and plan for your registration!!

clinical research amsterdam 2020

EUCROF is collaborating with both ACRON and BeCRO, the national associations of the Netherlands and Belgium to establish and run the conference.

As with previous conferences, we are arranging an extensive 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. For more information, click HERE

 

For further details please contact Darina Hrdličková at Darina.Hrdlickova@ppdi.com (Chair of the Organising Committee) and Michèle Garot, michele.garot@clincellence.com (Chair of the Programme Committee)

The Communication Working Group (CWG) has developed a brief online questionnaire aimed to collect information and graphic materials about future events you will attend on behalf of EUCROF.

The survey, that only takes 2 minutes, must be completed for every different event by members who will attend and allows to include information about the name of the event, the type of the event, as well we to upload the programme of the event and the presentation.

This tool is a very powerful way to keep the members informed about the future events attended by representatives on behalf of EUCROF by keeping the website regularly updated as well as to allow to disseminate the initiatives of the Federation in an efficient way and with more visibility.

Are you attending a future event on behalf of EUCROF? Please fill in the survey at this link.

The 2nd Kiev Clinical Research Forum will be held this year on May 16-17 in Kiev (Ukraine). The Forum is organized by PharmaSich, a CRO in Eastern Europe headquartered in Kiev, Ukraine and is held under the patronage of the European CRO Federation (EUCROF).

Martine Dehlinger-Kremer, President of EUCROF, along with Dr Sergii Myronenko from PharmaSich CRO, are part of the Organising Committee.

The event aims to bring together international experts from industry, regulatory agencies, academia and non-profit boards to share views and knowledge on clinical research among all the participants, providing networking opportunities and adequate discussion between speakers and audience.

This second edition intends to follow the huge success of the inaugural forum held in November 2017 and attended by 256 delegates form 19 countries.

Registrations are open! You can find further information on the event here.

EUCROF is supporting MedTech Europe which is organising its next forum on 14-16 May in Paris at the Cité des Sciences et de l’Industrie. The 2019 Forum will include one full day dedicated to start-ups and SMEs - the Start-up Day organised by the French MedTech Association SNITEM on 14 May and two days of conference, bringing together the key topics of the MedTech Forum and the legal & compliance programme of the Global MedTech Compliance Conference on 15 and 16 May (the GMTCC, jointly organised by MedTech Europe & AdvaMed).

If you are interested to find out more, please CLICK HERE.