eNews October 2018

Dear Members, Associate Members, Partners and All,

 

Together with the EUCROF Board, I am very happy to present our fourth EUCROF Newsletter of 2018, reviewing activities since July 2018 and looking ahead at what is planned in the coming months. Since our last eNews, as you will see, EUCROF and its Members have continued to be very actively involved in many industry initiatives.

Firstly, we have continued with our active support of the EMA and its development of its Clinical Trials Database and Portal, an integral prerequisite for the implementation of the EU Clinical Trials Regulation. EUCROF is now viewed by the EMA as a User Acceptance Tester (UAT) Champion and our main tester, Ingeborg Boddeke has been invited to participate in the on-site pre-UAT execution, which has just commenced in London. Our sincere thanks to Ingeborg for her time and commitment to supporting this important initiative. We also plan to be involved in the on-site and off-site testing of UAT 7 scheduled for early 2019. 


We have continued with our collaboration with the EMA in other areas as well, including attending a number of meetings in areas such as paediatric clinical research, the Regulatory Science to 2025 workshop on 24 October and the forthcoming Telematics meeting in November. So, my thanks to everyone who helps EUCROF play such a significant role with the Agency. 


The Executive Board is very pleased to see the re-launch of the Education and Training Working Group which will be led by Donato Bonifazi. This WG plays such an important part in EUCROF achieving its objectives, including the webinars and other educational initiatives. If you are interested in getting involved please put your name forward as soon as possible. 


Progress has been also made with the initiation of activities toward our next International Conference to be held in Amsterdam in 2020 and you will all be hearing more update about this Conference in the coming months. 


Also, I am pleased to inform you that EUCROF has further increased its geographical reach with the addition of an Associate Member, Optimapharm, from Croatia. Welcome to EUCROF! 


Finally, the General Assembly on 5th and 6th December will soon be upon us all and I, together will my fellow Executive Board Members very much look forward to meeting many of you in London for 2 days of discussion and debate. My thanks to the Clinical and Contract Research Association for hosting the event and making all of the arrangements. 


In the meantime, enjoy the read…


Martine Dehlinger-Kremer
EUCROF President

As you all are aware, EUCROF has been involved in supporting the User Acceptance Testing of 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.

I am pleased to announce that, as part of the UAT 7 approach, EUCROF, represented by Ingeborg Boddeke, has been invited, together with only 3 other industry stakeholders, to participate as a Sponsor UAT Champion in the on-site pre-UAT execution, which has just commenced (Mon 05th Nov to Tue 13th Nov, 2018).

Candidates have been selected based on participation in previous on-site UAT and recent involvement in the review of detailed UAT 7 test scripts. The chosen participants are as follows:

Organisation   Representative
 EUCROF  Ingeborg Boddeke
 ACRO  Ruediger Pankow
 EFPIA  Milagros Blazquez
 EORTC  Stéphanie Kromar

The role of the sponsor representatives in pre-UAT will be to assist with the testing of the sponsor functionality (alongside member state delegates), using the UAT 7 test scripts which have been endorsed by the CTIS Expert Group.  The outcome of Pre-UAT 7 will factor into the decision of whether or not UAT 7 will commence in Jan-2019.

Thereafter, it is anticipated that Ingeborg Boddeke, ACRON &GCP Central, B.V., who has participated throughout, will participate in the actual UAT 7 in 2019. 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.

EMA Stakeholder meetings continued on 26th September. They focused on the ongoing development of the EU CT Portal and Database and, as always, were attended by industry and academic stakeholders, as well as representatives from Member State regulatory authorities. EUCROF was represented by Dr Martine Dehlinger-Kremer (President), Stefano Marini (Vice President), Dagmar Chase (Chair Clinical Trial Legislation Working Group) and Simon Lee (Secretary). The meeting provided an update on the implementation of the European Clinical Trials Regulation, now expected later in 2020, and a 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 January 2019 – 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 do not hesitate contacting Simon Lee at .    

A new EUCROF Education & Training Working Group has been launched, with the aim to strengthen both events and training in the light of the educational vocation of all the activities EUCROF offers to its associates and external stakeholders.

Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche, will be the chair of this new working group that intends to deliver activities to build relationships across organisational boundaries, as well as to give training staff the opportunity to develop skills, expertise and to grow within their role. The WG will identify, support and promote good practices in education in clinical research and deliver accredited training activities. It will also provide a forum for discussion of key issues, impacting clinical research and opportunities for learning, and enhance professional competence as well as wider confidence and understanding of clinical research.

A call of application will be launched soon to collect expression of interest of the members.

Further information is available here.

The stakeholder Meeting “Shaping regulatory science to 2025” took place at the EMA in London on Wednesday, 24 October 2018. EUCROF attended, represented by Dr Martine Dehlinger-Kremer.

The aim of the meeting was to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.

 

The workshop offered an opportunity to reflect on the scientific and technological advances in the pharmaceutical arena, the challenges that the Agency’s scientific committees and working parties will face in the future and to look at initial proposals to address them. It did also highlight areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.


The five priorities of the Regulatory Science Strategy to 2025include:

  • 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;

  • addressing emerging health threats and availability/therapeutic challenges;

  • enabling and leveraging research and innovation in regulatory science.


More information is available here.

The Clinical Trial Facilitation Group (CTFG) Stakeholder Meeting took place in Bonn on Wednesday, 24 October 2018. EUCROF attended, represented by Dr Stefano Marini and Dr Dagmar Chase. The meeting developed the following topics:

 

  • EU Clinical Trial Regulation Implementation - Status and Challenges;
  • Innovative (Complex) Trial Design - Follow up;
  • Future Activities and Horizon Scan Clinical Trials – ‘Independent of upcoming CTR’;
  • Burning issues in/for Clinical Trials. 

 

Click here to view the agenda of the meeting.

A new version of the European Medicines Agency (EMA) corporate website, designed to work optimally on the latest web browsers, has been launched in September 2018, providing a number of new features to improve user experience, including:

  • An improved search, allowing users to find content easily and to filter their search results. EMA plans to further refine this functionality in the future;
  • A ‘responsive’ design for cleaner display on mobile devices;
  • Simpler URLs, based on the location and title of webpages or documents;
  • An updated visual design offering user a clearer reading experience and simpler navigation

 

The website’s content and structure remain unchanged. Although the site’s URLs are new, URLs from the previous website will continue to work for every page and document, thanks to one-to-one redirects.

You can visit the website here: https://www.ema.europa.eu. 

On 25th and 26th October, the “Better Medicines for Children Conference - From Development to Access” took place in Brussels. The annual paediatric conference is an annual event jointly organized by the European Forum for Good Clinical Practice (EFGCP) and the Drug Information Association (DIA) and the support of the PDCO (Paediatric Committee at the EMA) with a focus on new developments in children medicine.

 

Dr Martine Dehlinger-Kremer participated in the event. She opened the conference, was a member of the Jury for the posters, acted as rapporteur of the neonates session and together with the Chair of the PDCO, closed the conference.

 

This year event was aimed at taking stock of the progress achieved after 10 years of Paediatric Regulation and, to move the discussion toward the experience of patients, shading light on what could be done to optimise children’s access to new medicines.

 

The conference provided a unique occasion to all stakeholders involved in the process, from research to treatment of children diseases, including HTA professionals and payers, as well as patients to share updates in the field and discuss challenges related to the development of paediatric medicines.

 

The event benefited from the participation of key speakers representing EMA, FDA, National Authorities, HTAs, Payers, healthcare professionals, clinical researchers and patients.

 

For more details about the conference, click here.

The European Medicines Agency (EMA) and the European Commission have released an updating of their guidance which will support pharmaceutical companies in the UK’s withdrawal from the European Union (EU). In particular, the document elucidates how Brexit will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR). It also explains how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected. Additionally, the updated document includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPV) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK. At any rate, to avoid any impact on the continuous supply of medicines for both human and veterinary use within the EU, companies are being reminded to plan for the UK’s withdrawal from the EU on 29 March 2019. Companies are advised to continually monitor the EMA webpage dedicated to the consequences of the UK’s withdrawal from the EU.

More information is available here.    

On 13 -14 September, Stefano Marini represented EUCROF at the 3rd Annual Clinical Trial Quality & Compliance meeting held in Vienna. The meeting was well attended by industry stakeholders and focused on the current topics in this sector.

 

Stefano presented an update on the new EU Clinical Trial Portal.

 

Click HERE for more information.

Single pill for HIV-1 treatment has been approved by European Commission

Dolutegravir/rilpivirine is the first two-drug regimen, once-daily single pill for the treatment of HIV-1 in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor. The European Commission has approved JULUCA (dolutegravir/rilpivirine), marking a significant milestone in HIV treatment history. Dolutegravir/rilpivirine is a combination of two antiretrovirals within a single-pill regimen, resulting in people living with HIV-1 having less drug exposure, all the while maintaining the efficiency of the traditional three-drug regimens at 48 weeks. This approval offers another treatment option to the 810,000 people estimated to be living with HIV in Europe. It follows the positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on 22nd March 2018.

 

Improving the efficiency of chemotherapy with a new molecule

Researchers from the CNRS and Université Nice Sophia Antipolis, France, have demonstrated that methiothepin, a small molecule, can improve the efficiency of chemotherapy by inhibiting the resistance of certain tumours. Cancerous tumours are capable of ‘detoxing’, subsequently limiting the efficiency of chemotherapy. The patched membrane protein seems to play a key role in this phenomenon, being capable of expelling some of the primary active ingredients of chemotherapy from cancerous cells in numerous tumours such as melanoma, adrenocortical cancer and breast cancer. The rejection of these toxic substances enables the tumour to eventually survive the treatment. After demonstrating that patched actively contributes to resistance to doxorubicin, one of the medicines used in chemotherapy, the researcher’s team investigated its inhibition through a small molecule called methiothepin. They found that a combination of doxorubicin and methiothepin contributes to destroy tumours more efficiently than doxorubicin alone, both in vitro on cancerous human cells and in vivo on these same cells grafted in mice. Moreover, they observed that methiothepin fostered the accumulation of the treatment in cancerous cells, as well as its efficiency, and they demonstrated that the combination of two molecules does not increase the quantity of doxorubicin in the hearts of the mice studied, which is an important point, as this compound is known for its cardiotoxicity. These results of the new study were on the cover of the July 2018 issue of the International Journal of Cancer.

 

Council of Europe protocol on genetic testing enters into force

The Council of Europe’s protocol on genetic testing, part of its Convention on Human Rights and Biomedicine, has entered into force. The protocol on genetic testing, officially called the ‘Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes’, provides a legal and regulatory framework for genetic testing. The protocol specifies the conditions under which tests can be carried out in a variety of circumstances and addresses any potential ethical concerns over testing. The aim of the protocol is to protect the dignity, rights and fundamental freedoms of all human beings, while at the same time acknowledging the potential benefits of genetic testing in the field of health and facilitating the saving of lives and improvements in the quality of treatment on offer that is made possible by progress in medical science. It also specifies the conditions under which a test may be carried out on a person who is unable to consent, which has previously been an area of ethical concern for biomedicine stakeholders.

More information is available here.


Innovative Medicines Initiative launches new Calls for proposals

In July 2018 two new Calls for proposal, IMI2 Calls 15 and 16, were launched with a total budget of 434 million. Around half of this comes from Horizon 2020, the EU’s framework programme for research and innovation. The other half comes from EFPIA companies and IMI Associated Partners; these do not receive any funding from IMI but contribute to projects, mainly through ‘in-kind’ contributions (e.g. researchers’ time). A new Antimicrobial Resistance (AMR) Accelerator Programme is part of new Calls for proposals launched by the Innovative Medicines Initiative (IMI). Of the other topics launched in the Calls, many address brain disorders (e.g. Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, major depression) and immune-mediated diseases (e.g. rheumatoid arthritis and lupus as well as inflammatory bowel diseases such as Crohn’s and colitis, and skin diseases like dermatitis and psoriasis). Among other things, the topics aim to make clinical trials more patient-centric, contribute to medicines safety, and apply blockchain technologies to the drug development and health sectors.



Further details on the topic for each Call, are available here.

With the help and support of our UK colleagues of CCRA, our next full end of year General Assembly will be in London on 6th & 7th December 2018.

 

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 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.

 

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

With both the Programme and Organisation Committees in place, activities to prepare for the next Conference are gathering momentum.

The EUCROF Executive Board asked Michele Garot and Darina Hrdličková to take the role of initiator (i.e. temporary chair) for the Programme and Organising Committees respectively. Given their successful involvement in previous Conferences, this is a positive step. 

Venue is soon to be finalised and the draft agenda developed.


If you are interested in joining either of these Committees and contributing to the success of the next Conference please contact Assia Rosati at . 

A meeting between the EU Telematics and the Industry Stakeholders will be held next 8th November 2018 in London at the European Medicines Agency. EU Telematics is the collective name for a joint endeavour in the context of the regulation of medicines for human and veterinary use between the European Commission, the European Medicines Agency and national competent authorities (medicines regulatory authorities in Member States). Together, these make up the European medicines regulatory network.

EU Telematics aims to put in place and maintain common information-technology (IT) services to implement European pharmaceutical policy and legislation. EU Telematics is governed by the EU Telematics Management Board, which interacts with both the European Medicines Agency's Management Board and the Heads of Medicines Agencies and oversees the activities of the IT Directors Group and its subgroup, the IT Directors Executive Committee.


The workshop will mainly focus on human medicines however issues common to both human and veterinary medicines will be addressed in the context of Brexit.


Stay tuned!

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

On 21st-22nd November Michele Garot will be representing EUCROF at the GCP Readiness Conference in Brussels, Belgium, presenting on the EU Clinical Trial Regulation.


Martine Dehlinger-Kremer and Stefano Marini will be presenting and involved in sessions at the 2nd Kiev Clinical Research Forum, 16-17 May 2019, Kiev Ukraine.  EUCROF will be supporting the conference with Martine Dehlinger-Kremer acting as Key Advisor to the conference and Stefano Marini, Yoani Matasakis plus further EUCROF members presenting at various sessions during the conference.


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