eNews July 2018

Dear Members, Associate Members, Partners and All,

 

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

Since our last eNews in April 2018, as you will see, the last months have been very rich in activities and initiatives. Firstly, the Spring General Assembly held in Bratislava in May was a great success and I wish to thank SACROP for hosting the event, for the warm hospitality and the excellent organisation. We have continued with our collaboration with the EMA, attending a number of meetings in areas such as paediatric clinical research (EUCROF has a position of Observer Member in the Coordination Group of Enpr-EMA at the EMA), electronic archiving and continued the development of the EU Clinical Trial Database and Portal, a vital pre-requisite of the EMA’s ability to implement the EU Clinical Trials Regulation. So, my thanks to whoever helps EUCROF play such a significant role with the Agency which, in the end, will benefit all members and clinical research. Also, progress has been made with the initiation of activities toward our next EUCROF International Conference to be held in Amsterdam in 2020. EUCROF has continued to provide its training opportunities presented to members and clients, through our webinars and the intense activities of our Working Groups, with key subject matter experts.

 

Our new website has been launched which we hope will be of great interest to whoever visits it in the coming years. My thanks to Christophe Golenvaux and all the members of the Communication Working Group for their significant efforts in developing the new site.

 

I am pleased to say that we now have established our collaboration with the French Data Protection Agency – CNIL – which will be acting as the Data Protection Authority for EUCROF and which is supportive of our initiative to develop and implement a Code of Conduct in Data Protection. This will be an important tool for our members and others, now that the new Data Protection Regulation is in place in Europe.

 

EUCROF’s influence is growing across many aspects of Clinical Research: thank you in advance for your continued contribution to our success.

 

I wish you a happy reading and a nice summer.

Martine Dehlinger-Kremer
EUCROF President

EUCROF held its Spring General Assembly in Bratislava on 25th May 2018, preceded by a social event the evening before, at the kind invitation of our Slovakian colleagues of SACROP. Our sincere thanks to SACROP for their excellent planning and hospitality during our stay.

The meeting was a great success with 21 representatives from our Member Associations in attendance and 3 further joining through the “GoToMeeting” platform.

Martine Dehlinger-Kremer (MDK), our President, welcomed Members attending the General Assembly and introduced the following agenda:

  • Summary of EUCROF Activities 2018
  • Review of Objectives
  • EUCROF International Representation
  • Financial Report 2017
  • SOP for WGs
  • Guidance document for conferences
  • Conclusion from EUCROF Vienna Conference 2018
  • EUCROF Conference in Amsterdam in 2020
  • Working Groups Updates
  • Revamping of Outsourcing Management Working Group
  • CT Regulation, EU Portal and Database, UAT
  • GDPR – Code of Conduct Update
  • Brexit Update
  • Meeting with SACROP including a presentation from the Association of Innovative Pharmaceutical Industry: initiatives concerning clinical trials in Slovakia.

 

As you can see, it was an extensive agenda with many important topics presented and discussed. For each of the agenda topics above there are slides available for reference and further details plus the minutes of the meeting, all of which are available in the restricted members’ area on the EUCROF website.

For further information please contact the Secretary and/or President via email on or   and/or or .

The Education and Training Working Group organised a webinar providing an insight into ‘Understanding the implications of the new General Data Protection Regulation’ on 10 July 2018. It had 54 attendees, including both EUCROF members (31) as well as non – members (23), which is excellent news for this very important topic impacting us all.

The webinar gave the framework of the new General Data Protection Regulation (GDPR), highlighting the issues and provided the attendees with advice on complying with the Regulation.

 

The areas covered were:

  1. Focus on the GDPR dispositions applicable to all European states;
  2. Examples of how it articulates with national laws, i.e. French specificities.

 

The points the webinar highlighted are as follows:

  • The different individual roles in data processing (data subject, data controller, data processor, recipient, third party);
  • What constitutes personal data, pseudonymized data, anonymized data, and personal health data?
  • Informing the data subject on processing and on its rights in research, addressing the question of how to update the information and consent form with GDPR requirements.

 

The webinar gave attendees an overview of new conformity obligations under GDPR, such as the obligation to keep a record of processing activities, the requirement to designate a Data Protection Officer, how to carry out a Protection Impact Assessment and the notification obligation to follow in case of data breach, etc.

 

The additional compliance tools to help those processing data to comply with GDPR were discussed, focusing in particular on the code of conduct EUCROF aims to provide.

 

Finally, the speaker provided a brief introduction to cross-border data transfer.

 

Our guest speaker, Joséphine Flament, has practiced as a specialist in French business law in the field of health and has developed a particular expertise in health data protection.

As you are probably aware from the last eNEWS, EUCROF’s New Technologies Working Group has been working on an initiative to establish a Code of Conduct for CROs in compliance with the new European General Data Protection Regulation, implemented on 25 May 2018.

 

Our President, Martine Dehlinger-Kremer, Yoani Matsakis (Treasurer of EUCROF, as well as Co-chair of the NTWG), Dennis Comet (President AFCROs) and Joséphine Flament (lawyer) met face to face with representatives of CNIL (the French Data Protection Agency) on 06 July 2018 to discuss potential future collaboration with the preparation and ultimate endorsement of the Code of Conduct.

 

The meeting was very successful and CNIL agreed to support EUCROF with the development of its Code of Conduct. Receiving such recognition is a vital first step and further meetings will follow.

 

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

During the meeting with CNIL on 06 July 2018, CNIL accepted to act as the lead Data Protection Authority (DPA) for EUCROF CoC as well as the DPA for EUCROF's compliance with GDPR. In addition, CNIL has confirmed that EUCROF could provide DPO services to its members who would not be in the position to have their own DPO. An important step for GDPR compliance.

The Communication WG, chaired by Christophe Golenvaux, has been working hard to upgrade EUCROF’s website which was launched at the end of May. The EUCROF Executive Board sees this as a very important tool in the communication with Members and the wider industry.

 

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, thoughts or ideas please contact Christophe Golenvaux ().

In compliance with EUCROF’s Bylaws, the Executive Board’s mandate expires after 2 years in December 2018. On this basis, elections should take place at the next General Assembly on December 6th in London.

 

To this end, a communication was sent to each national association Member, asking them to consider and discuss possible candidates to propose for these elections. All positions are open as follows:

  • President
  • Vice-President
  • Secretary
  • Treasurer
  • Executive Board Member.

 

National Associations should make applications in writing to the Secretary of the Federation at least 4 weeks before the election, therefore in this case by Monday 5th November 2018.

 

For further details please contact Assia Rosati at and/or Simon Lee (Secretary) at or .

In order to start up activities on the next EUCROF conference, taking place in Amsterdam in 2020, the EUCROF Executive Board has asked Michèle Garot and Darina Hrdličková to take the role of initiator (i.e. temporary chair) for the Programme and Organising Committees respectively, which they have duly accepted. Given their successful involvement in previous Conferences, this is a positive step. As per the SOP presented at the GA in May 2018, the initiators will organise the 1st Committee meeting with the working group representatives who expressed interest to participate in the conference and during that meeting agree / nominate their “permanent” chair of the Committee.

 

If you have further questions regarding either of these Committees please contact Assia Rosati at .

EUCROF representatives have continued to collaborate with the EMA to contribute to the progression of the development of the EU Clinical Trials Database and Portal.

 

On April 25th a meeting at the EMA focused on the ongoing development of the EU CT Portal and Database and, as always, was attended by industry and academic stakeholders, as well as representatives from Member State regulatory authorities. EUCROF was represented by Dr Martine Dehlinger-Kremer (President), Dagmar Chase (Chair Clinical Trial Legislation Working Group) and Simon Lee (Secretary). This was followed by a WebEx meeting on 28th June. Both meetings provided an update on the implementation of the European Clinical Trials Regulation now expected probably in 2020 and look at the progress being made with the EU CT Portal and Database, a key pre-requisite of the implementation. The next UAT7 was also covered and is now scheduled to take place in November 2018 – see later under “Forthcoming Events”.

 

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 simon.lee@quotientsciences.com.

Representatives from EUCROF were invited to attend and, in some cases, present at various key meetings in the last quarter.

 

EUCROF’s President, Martine Dehlinger-Kremer, Chair of the Paediatric Working Group and a specialist in this area, joined by Donato Bonifazi, attended

  • Enpr-EMA Annual Workshop on 7 June and the annual meeting of Enpr-EMA Members and Coordinating Group meeting on 8 June at the EMA in London.

Since April 2018, EUCROF is an observer member of the Enpr-EMA Coordinating Group

 

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

 

Alan Yeoman, Chair of the New Technologies Working Group, was invited to attend a Workshop with interested parties on topics related to electronic archiving of study data and related subjects at the EMA in London on 8 May 2018.

If you are interested to hear more, please contact Alan Yeomans at .

 

EUCROF’s Treasurer and Co-chair of the New Technologies Working Group, Yoani Matsakis, presented at the eClinical Forum in Darmstadt, Germany on 16 May 2018 on

  • Towards a EUCROF Code of Conduct for Data Protection?

If you are interested to hear more, please contact Yoani Matsakis at or .

With the help and support of our UK colleagues of CCRA, we are organising our next full end-of-year General Assembly in London on 6 & 7 December 2018.

 

You are cordially invited to attend the General Assembly and each Association/Member/Partner is invited to send at least one representative.

 

Information has been sent to all our Member Associations/Members/Partners, so we hope you have this date in your calendar. We are looking forward to seeing you all in London!

 

In order to get the best rates on the selected hotel for the Conference, please confirm your booking as soon as possible, otherwise the discounted price cannot be guaranteed.

More details will be sent out 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 at .

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 from GCP Central (a member of ACRON), who has participated throughout, including UAT6, will be EUCROF’s lead tester with Lidya Dominguez Burgo from Sermes (a member of AECIC) and Aneta Wojtczak from PSI (a member of SACROP), both as reserves. Our thanks in advance for their contribution and dedication.

 

Further 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 simon.lee@quotientsciences.com.

The Clinical Trial Legislation WG providing comments on the EMA Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use, in accordance with Good Clinical Practice and Good Manufacturing Practice.

 

Comments will be submitted ahead of the 31 August deadline.

 

If you have any queries please contact Dagmar Chase, Chair of the WG, at .

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

 

There is continued interest within the EUCROF membership to establish two new Working Groups in Patient Associations and Geriatrics.

 

The Patient Association working group has been launched 19 March 2018. The Chair is Hervé Servy from Sanoia (a member of AFCROs) and there are further 8 Members.

 

The WG will focus on identifying best practice to connect patients and clinical research.

 

There is interest in establishing a WG in the area of Geriatrics which is becoming an area of increasing needs. 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 Vice President, Dr Stefano Marini, has 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 and to attend the AICRO annual event in October.

 

Our President, Martine Dehlinger-Kremer, has been invited to present at the DIA/EFGCP meeting on Better Medicines for Children in Brussels, Belgium on 25 & 26 October 2018, at the TOPRA Paediatric Conference, in London on 31 October 2018 and Partnerships Clinical Trials (PCT) in Barcelona, 27-29 Nov 2018.

 

If you have any questions please contact Assia Rosati via email on .

Following the successful conference in 2017, our Ukrainian colleagues are planning to hold a second Clinical Research Forum in Kiev in May 2019. As with the first, the Forum will be a unique discussion platform for clinical research industry in Eastern Europe.

 

EUCROF’s President, Martine Dehlinger-Kremer, will be the Key Conference Advisor and various members of EUCROF will be invited to contribute to the conference.

 

More details to follow in due course.