eNews October 2017

Dear Members, Associate Members, Partners and All,

 

Since the last eNews in May, EUCROF and its members have been involved in numerous activities and initiatives. 

We continued to be invited to meetings at the EMA as well as external conferences, which together with our very active Working Groups, ensure we contribute to the debate on the key topics impacting our industry. In addition I am pleased to say that our membership has increased again with one additional Associate Member and two new Partners.

Last but not least, the programme for the 4th EUCROF International Conference in Vienna has been finalised and registration is now open. We are counting on you all to make this Conference a success!

 

Thank you all for your contribution to these great achievements.

 

I wish you a happy reading.

Martine Dehlinger-Kremer

As you know from previous communications EUCROF will be holding its 4th EUCROF International Conference in Vienna, from 26th to 27th February 2018. The venue will be the Austria Trend Hotel Conference Facility, Olympia Mancini Hall.

The Programme for this Conference is now available on line and registration is open. 

The key note speaker for the conference will be Dr. h.c. Peter Kapitein, president / co-founder (and Patient Advocate) of the International Advocacy Group Inspire2Live.

You will see a series of communications about the conference over the coming months.

 

Your involvement will be key to the success of this conference, so please act now: promote its existence across all of your contacts. This will be important for us to attract large numbers of attendees, together with encouraging sponsorship.

 

To book your place on the website. For further details please contact Darina Hrdličková at  (Chair of the Organising Committee) and Michèle Garot,  (Chair of the Programme Committee)

Three years ago, EUCROF carried out a satisfaction survey of its members and decided that it would like to seek their opinion once again. The scope of the survey was to measure Member’s perception about the previous three years of EUCROF activities and to collect opinion about what Members expect from EUCROF in the future.

Input was sought from EUCROF member (board member of a local association) or as member of an individual company pertaining to a local CRO association.


The EUCROF Communication Working Group has prepared the on-line survey which was completed between July and September. Based on the collected feedback, EUCROF will compare the 2017 results with those of 2014 and will present the conclusions at the next General Assembly in Madrid on 21st & 22nd November 2017.

The survey closed on 30 September 2017. The Communication Working Group and the Executive Board wish to thank whoever took the time to complete the survey.


For further information please contact the Chair of the Communication Working Group, Christophe Golenvaux on 

As you know, EUCROF has many active Working Groups which are all important in contributing to EUCROF’s success. However EUCROF is always open to support additional Working Groups in areas not covered yet. Therefore EUCROF is pleased to announce the establishment of a new WG focused on Innovative Medicines.

As we are going through a challenging time regarding EU legislation for clinical trials and the clinical research, using all 3 categories of advanced therapies plus the significant ongoing debate, this WG is being set-up to address these issues.

 

If you are interested in becoming an active member of this new WG please contact Astrid Pañeda Rodriguez directly via email at

The Clinical Trial Legislation Working Group has continued to be active in providing feedback on new Guidance issued by the EMA for Consultation in the last few months as follows:-

Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials' (EMA/15975/2016) in July 2017. (Click here to see the comments)

and

 

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol in August 2017. (Click here to see the comments)

 

If you wish to know more or to get involved, please contact Dagmar Chase at 

 

If you are interested in learning more about EUCROF’s other active Working Groups please contact the respective chairs as follows:

Communication WG - contact Christophe Golenvaux ()

Education & Training WG – contact Antoinette Van Dijk ()

Late Phase WG - Giovanni Fiori ()

Medical Devices WG - contact Burcu Cehreli ()

Paediatric WG - contact Martine Dehlinger-Kremer ()

New Technologies WG - contact Alan Yeomans () and Yoani Matsakis ()

Pharmacovigilance WG - contact Nicolas Tsiakkas ().

 

Each of EUCROF’S active Working Groups will present an update of their activities, past and present, at the General Assembly in Madrid this November.

EUCROF’s Pharmacovigilance Working Group has been very busy recently and in September published a paper (the first of a series of 3) entitled ‘Pharmacovigilance in 2020: Boldly Shaping the Future - An overview, Part 1: Where we are. Following is an Abstract for the paper.

Abstract:

Since the start of the modern pharmacovigilance era in the 60s (sparked by the Thalidomide tragedy) the discipline has been steadily gaining importance in the pharmaceutical industry.

The changing role of pharmacovigilance (PV) has been most notable over the past few years with a “paradigm shift” that moved PV-related regulatory requirements away from simple “event counting” to “benefit/risk” evaluation and more recently to “proactive risk management”.

While regulators will keep the emphasis on adequate collection of key information on medicines, PV functions will also be expected to conduct analysis of both safety and effectiveness data and information, and undertake corrective/proactive actions to safeguard public health. This will be expected across all phases of the product life cycle.

Examples of the European Medicine Agency’s (EMA’s) more all-encompassing approach to safety include the fairly recent creation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the sharp increase of regulatory inspections.

At a company level, PV departments are finding their roles have become increasingly strategic. Not only must they respond to a higher number of more complex regulatory requirements but they are also involved in some high-level business and inter-departmental activities within their own companies. Examples of these new activities include greater collaborating with medical information and medical affairs departments, increasing involvement in the conduct of PV intelligence, involvement with vendors assisting patient support programmes, supporting mergers and acquisitions (M&As) negotiations, and involvement with non-interventional studies. Other future challenges will include the use of web and social media networks for PV purposes or personalised medicine. As a result, the “traditional” boundaries between the different phases of the life cycle of a drug are becoming more and more blurred, with a greater degree of overlapping between traditional regulatory, medical, and PV activities.

Managing the current and growing demands on PV departments requires team members to have multiple and diverse operational and management skills. For small and mid-sized companies, this adds enormous resource pressure. In such cases, outsourcing part or all the PV-related activities could be the most efficient and cost-effective strategy.

To view the whole paper Click here.

 

Finally, the Working Group would like to use the announcement of this paper to identify and collect names/contact details of EUCROF members who are expert or at least interested in pharmacovigilance topics and may wish to contribute to this WG deliverables. This is an opportunity to showcase EMA that we are representing a significant community and not only 9 peoples of the PV WG.

If you are interested please contact Xavier FOURNIE, 

In June, EUCROF’s President, Dr Martine Dehlinger-Kremer, attended and presented at a meeting of Global Research in Paediatrics - Network of Excellence. GRiP is an EU-funded project, which aims to stimulate and facilitate the development and safe use of medicines in children.

The meeting in Padua was the last meeting of GRiP. As such it was an honour to be invited to this exceptional event.

GRiP has achieved a lot in paediatric research. The follow-up will be the Pan European Paediatric Working Group, an IMI2 funded project.

 

For more information please go to www.grip-network.org

A EUCROF team, consisting of Yoani Matsakis, Dagmar Chase, Michèle Garot

Ana Patacão and Alan Yeomans, presented at the Good Clinical Practice Inspectors Working Group (GCP IWG) on 12 June 2017 at the premises of the European Medicines Agency.

The title of the meeting was: “Meeting with interested parties on topics related to e-source data/ EDC tools in clinical trials”

 

The meeting addressed some of the hot topics in clinical trials, including:

  1. Inspection findings related to e-systems & their vendors
  2. Risk based software validation
  3. Requirements for a good audit trail
  4. Electronic informed consent

 

The meeting was a mixture of presentations with discussion and comment sessions exploring these topics.

EUCROF representatives gave the following presentations:

  • Contractual requirements on the responsibilities of e-systems vendors with regards to GCP by Yoani Matsakis and Dagmar Chase
  • Views on the implementation of a risk based approach to computer systems validation by Yoani Matsakis
  • Methodologies used for system validation (e.g. agile methodologies) and documentary evidence produced by Yoani Matsakis and Alan Yeomans.
  • Electronic informed consent by Stefanie Broes

 

For further information please contact Assia Rosati at  and Martine Dehlinger-Kremer at .

We are pleased to welcome a new Associate Member to the EUCROF family, namely CVBF from Albania, and two new Partners, namely Clinica Group from Algiers and ClinServ from Lebanon.

 

CVBF acts as a Contract Research Organisation to conduct GCP clinical trials and supporting companies willing to conduct clinical research in Albania. It provides full-service support, including one stop local solutions to investigators, sponsors, CROs and research institutions. For more information visit: www.cvbf.net

 

Clinica Group - This relationship was first established when EUCROF’s Vice President, Dr Stefano Marini, attended and presented at a Round Table on “Access to Innovation & Clinical Research” that Pitch World Fast, organised with the Ministry of Health of Algeria.

CLINICA Group was created in 2007 and is accredited by the Algerian Ministry of Health. It is the first active and practicing CRO in Algeria. Clinica’s experienced teams are involved in the management of interventional, observational and pharmacoepidemiological studies in different therapeutic areas (drug and medical device). For more information visit: www.clinicagroup.com

 

ClinServ International - is a full-service CRO established in Paris in 2002 and expanded through the Middle East, Africa Gulf and Persian countries; ClinServ is considered a sustainable Healthcare R&D infrastructure in the region, in terms of: Clinical Research Monitoring and Project Management

IMP Logistics & Regulatory Affairs Management. ClinServ aspires to become the market leader in healthcare R&D in the Middle East, GCC, Africa, and Persia by 2020 and is EUCROF’s first active Partner in the region. 

For more information visit: www.clinserv.net

Overview: “Extrapolation approach in paediatric clinical research: chances and bottlenecks”

 

In the last decades, it has been widely accepted that the development of medicines for use in children should undergo strict qualitative, ethical and procedural rules, in order to appropriately authorise them for paediatric use.

Thus, considering the vulnerability of this population, all the efforts to minimise unnecessary studies in children have to be made. Moreover, economic burdens and methodological, feasibility and ethical issues strongly impact on the number of children that can be enrolled into a clinical trial and this becomes more complex in the case of rare diseases. For this reason, new methodological strategies have to be explored to exploit the rich source of data that are already available, especially for the adult population.

 

In this scenario, the extrapolation approach, intended as “extending information and conclusions available from studies in one or more source population, to make inferences for another target population”, is an important tool to adopt when planning a paediatric medicine development programme, possibly allowing for a reduction in new data to be generated for conclusion in paediatric populations.

This approach has been included in the recent ICH-E11 guideline revision and is increasingly adopted in the official paediatric development plans proposed to EMA and FDA.

This webinar provided an overview of the use of extrapolation of efficacy and safety data in paediatric medicine development, pointing out positive experiences and difficulties. A case-study and several examples were presented.

 

By attending this webinar, participants gained a better awareness of the opportunities and the requirements for the extrapolation approach in paediatric medicines development, with a particular insight on the regulatory scenario.

The presenter was Dr. Lucia Ruggieri, Researcher at Gianni Benzi Pharmacological Research Foundation, TEDDY Network Scientific Secretariat

 

Overview: “Informed participation and patient empowerment: a patient-centred approach to improve paediatric clinical research”


Over the last years, a Europe-wide trend towards a patient-focused approach is developing and is influencing the decision-making process related to the clinical research. This new vision aims to draw on patient knowledge and experience in order to deliver benefits for all stakeholders of the drug development process, by favouring the identification of unmet needs, research priorities or as well as the optimization of clinical study design. In this context, the “patient empowerment” concept has been developed as an approach encouraging the active participation and self-determination of the patients in the caring procedure. An empowered patient acquires all the critical tools to make decisions regarding his/her health and interact with healthcare professionals. For this reason, the exchange of information and the constructive dialogue with the patients have become key points in clinical research.


In 2016, in fact, EUPATI (European Patients’ Academy) launched a public consultation, ended in September 2016 with the release of the EUPATI Guidance for patient involvement in the medicine research and development process. Likewise, the Consultation Document on “Summary of Clinical Trial Results for Laypersons” for the Implementation of Regulation (EU) No 536/2014 recommended a clear and comprehensible communication of the clinical trial results to the patient.

However, rarely all these attempts for the patient involvement pay attention to the paediatric population needs. Available data and publications show that ad hoc strategies to inform minors to be enrolled in clinical trials are seldom produced. The need to actively involve children in the decision-making process related to a clinical trial is in fact part of the updating guideline ‘Ethical considerations for clinical trials on medicinal products conducted with minors’ prepared by the European Commission and the Paediatric Committee within the Regulation EU 536/2014. A child-friendly approach is necessary not only in the daily clinical practice, but especially in all the activities related to the development and use of drugs. In case of studies involving children, age-tailored information booklets, assent forms and summaries of the results should be written in age appropriate, simple and understandable language to ensure ease reading by parents and children. Moreover, the investigators should obtain agreement from the child in addition to informed consent of the parents, even when this agreement is not mandatory by law.

The involvement of paediatric population in the decision-making process is also the aim of the YPAGs - Young Persons Advisory Groups, which represent a new global movement, providing fresh perspectives on research studies.

Overall, this webinar intended to describe the added value of a patient approach and the peculiarities and great value of this approach in the paediatric context.

 

Presenter - Mariangela Lupo - Master’s Degree in Political Science, International Relations. Bachelor’s Degree in Linguistic Mediation in the European Union. Responsible for Training and Communication and for the paediatric patients’ empowerment at Consorzio per Valutazioni Biologiche e Farmacologiche and the TEDDY Network (European Network of Excellence for Paediatric Clinical Research).

 

For more information contact Antoinette Van Dijk ()

With the help and support of our Spanish colleagues of AECIC, we are organizing our next General Assembly in Madrid, scheduled on Tuesday 21st and Wednesday 22nd November 2017.

You are cordially invited to attend the General Assembly and each association/partner is invited to send at least one representative.

There will be an informal dinner on Monday, November 20th, then on Tuesday 21st November the meeting will start at 09.00 am. You may thus consider arriving on Monday. The meeting will end on Wednesday, November 22nd, approximately at 15.30.

 

The accommodation and venue of the meeting is:

Holiday Inn Alalá

Calle de Alcalá, 476

28027 Madrid

Tel: +34 913 75 68 00

 

Mercedes Ramas, from AECIC, has agreed the special rate of 90 EUR per room per night on the occasion of our GA. To take advantage of this special rate, reservations must be performed by October 31st.

 

To book your room for the meeting, please fill in the form attached (click here) and send it to the attention of:

Mr. Diego López - 

Once you booked your flight, please send all your details to Assia Rosati () in the excel document you find attached (click here).

 

We are looking forward to seeing you all in Madrid!

As we informed you in previous communications, the UAT strategy for the UAT 6&7 includes not only off site User Acceptance Testing (UAT) but also the organization of on-site testing in the EMA facilities. The dates for the UAT 6, scheduled according to the revised development plan, are indicated below:

  • UAT 6 on site testing: Monday 06 Nov to Friday 10 Nov (5 days)

 

We have been allocated two spaces for testers (Ingeborg Boddeke of GCP Central in the Netherlands and Lidya Dominguez of SERMES CRO in Spain).

 

Simon Lee 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  or .

EUCROF’s next scheduled Webinar is on 11th October 2017 and will cover “EU Clinical Trials Regulation 536/2014: New Transparency Rules”

 

Overview

Article 81 of the EU Clinical Trials Regulation 536/2014 refers to the EU Database and indicates what kind of information will be publicly accessible or will not be in the public domain, respectively.
In the “Appendix on Disclosure Rules to the “Functional Specifications for the EU Portal and EU Database to be audited – EMA/42176/2014”, very detailed rules are outlined as to what should be made public and when – classified in three trial categories:
 

  • Category 1: Phase I, Bioequivalence, Bioavailability, and Biosimilar Trials
  • Category 2: Phase II and Phase III Trials
  • Category 3: Phase IV and low-intervention Trials.

 

In the future, the phase of a trial will have a significant impact on the transparency rules to obey.  It is also interesting to see what data will be made public. Trial protocol information and trial results are within all our expectations. However, we need to get used to the fact that – for example - serious breaches of the trial protocol or the Regulation will also be made public, as will inspection reports.

 
This Webinar will provide an overview of the new transparency rules. It will also cover the new draft “Guideline for the Notification of Serious Breaches of the Regulation (EU) No 536/2014 or the clinical trial protocol”.
 
After this Webinar, participants will have better awareness of future transparency rules and will be in a good position to analyse, which procedures are missing in their companies, thus putting them in a better position to get “Regulation ready”.

 

Presenter

Dr. Dagmar Chase
Managing Director
Clinrex GmbH
Munich, Germany

 

Please contact Antoinette Van Dijk ( ) for more information.

The above will be open to non-members with associated registration fee of 90 EUR (EUCROF Members 60 EUR).

PHARMASICH CRO, with the support of the European CRO Federation, holds Kiev Clinical Research Forum on 9-10 November 2017 in Kiev, Ukraine.

The Forum is the unique discussing platform for clinical research industry in Eastern Europe.

 

It will bring together 300 delegates and the speakers from 14 countries, representing the industry, regulatory agencies, academia and non-profit boards and will provide awesome networking opportunities and adequate discussion between speakers and audience.

The full programme and other details are available on the conference website:

www.conference-pharmasich.com

 

If you wish to make a presentation or take part in the panel discussion, please contact Dr Sergii Myronenko at 

Or, alternatively, we can set up a call to discuss the details.

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 second meeting that was scheduled to take place in 2017, the first having taken place in March. These are to discuss this important topic ahead of the implementation of the European Clinical Trials Regulation in 2019.

 

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 

  • Dr Stefano Marini (Vice- President) will be presenting at a course in Rome, Italy, on 9 October 2017 entitled "How a drug is born. From the Need for Animal Experimentation to Pharmacovigilance ". For further information Dr Stefano Marini at 
  • Dr Martine Dehlinger-Kremer (President) will be presenting at the DIA/EFGCP/EMA Conference on How to Optimise Children’s Access to Innovative Medicines London (EMA), UK on 16-17 October 2017. Martine Dehlinger-Kremer is a Member of Programme Committee & will chair a session on “How to optimize drug development up to approval and beyond”. For further information please contact Martine Dehlinger-Kremer at .
  • Christophe Golenvaux (Board Member) will be attending a round table meeting of the UIA (Union of International Associations) in Brussels, Belgium, on 10 November 2017. For more information please contact Christophe Golenvaux at 
  • Dr Martine Dehlinger-Kremer (President) will be presenting “The new Clinical Trials Regulation in the context of Paediatric Research” at the Paediatric Conference Eastern Europe in Budapest, Hungary on 14-15 November 2017. For further information please contact Martine Dehlinger-Kremer at