Programme Announced for the 4th EUCROF International Conference!

Conference clinical

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 This email address is being protected from spambots. You need JavaScript enabled to view it. (Chair of the Organising Committee) and Michèle Garot, This email address is being protected from spambots. You need JavaScript enabled to view it. (Chair of the Programme Committee)

 

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EUCROF’s Member Survey completed.

 

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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Continuing feedback on EMA Consultation papers…

 

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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 (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Education & Training WG – contact Antoinette Van Dijk (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Late Phase WG - Giovanni Fiori (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Medical Devices WG - contact Burcu Cehreli (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Paediatric WG - contact Martine Dehlinger-Kremer (This email address is being protected from spambots. You need JavaScript enabled to view it.)

New Technologies WG - contact Alan Yeomans (This email address is being protected from spambots. You need JavaScript enabled to view it.) and Yoani Matsakis (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Pharmacovigilance WG - contact Nicolas Tsiakkas (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

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.

 

[Back to e-News October 2017]

 

EUCROF’s New Working Group focused on Innovative Medicines

 

 

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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Paper published by the PV Working Group

 

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, This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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