How to Achieve a Successful New Trial Legislation

Published on 21 November 2011

On 4 July 2011, EFGCP organized, in collaboration with EORTC a Workshop on “How to Achieve a Successful New Trial Legislation”, a Multi-Stakeholder Workshop on Consensus and Strategy Development.

The workshop took place in Brussels and was meant to build consensus about preferred options and to develop strategies on how to enhance consensus building amongst all stakeholders in all EU Member States and the European Parliament to enable rapid new legislation for clinical trials. Progress has been made and several ideas came out during this successful workshop.

Download the final report of the meeting.

Newsletter Summer 2011

Download the newsletter

EMA presentation & summary June 15th 2011

Update: 07 August 2011

The documents, slides and information related to the EMA presentation held June the 15th can be found in the section for members only

The International Clinical Trial Day: Presentations

updated 21 October 2011

Presentation by the Dr Amant from the UZ Leuven about the Chemotherapy in Pregnancy Project.

Presentation by Frank Boeye, representative of patients associations.

Presentation by Jean Van Rampelbergh from Sanofi Aventis about the Pharma vision on clinical research.

Look at the videos :

Presentation Dr Frédéric Amant 1

Presentation Dr Frédéric Amant 2

Presentation Dr Frédéric Amant 3

Presentation Frank Boeye

Look at the pictures:

BeCRO 2011 Clinical Trials Day

The International Clinical Trial Day: press releases

BeCRO promotes Clinical Research - 19/05/2011

L'Echo

La Libre (épinglé) + La Libre (article)

Metro (Fr)

Metro (NL)

A press conference will be held at BeCRO offices on 20^th May at 14h00 when the board will be handing over the BeCRO donation to Prof Amant for his international research on Cancer in Pregnancy (for more info read the press release in French and Dutch).

En 5 ans, 3.000 études cliniques ont été réalisées dans nos hôpitaux. Une Journée Internationale leur est consacrée ce 20 mai.

Onze ziekenhuizen realiseerden 3000 klinische studies in de laatste 5 jaar. Een internationale dag wordt hen toegewijd op 20 mei.

België kan fier zijn op zijn rol in de klinische studies (studies in het kader van de ontwikkeling van een nieuw geneesmiddel). Ons land wordt inderdaad beschouwd als één van de beste in de wereld. En dan te bedenken dat 95% van de bevolking hier geen weet van heeft.

Vrijdag 20 mei – Internationale Dag van de Klinische Studie – is dan ook het uitgelezen moment om deze studies onder de aandacht te brengen van het grote publiek. Daarom zal BeCRO (De Belgische vereniging van Contract Research Organisaties) in samenwerking met de universitaire ziekenhuizen op die dag een informatiebrochure verspreiden over het proces van een klinische studie, hoe er aan deel te nemen en de rechten van de patiënt.

Als orgelpunt van de dag, zal Professor Frédéric Amant van het UZ Leuven een prijs in ontvangst nemen vanwege BeCRO ter ondersteuning van zijn onderzoek naar kankers tijdens de zwangerschap.

Persbericht - Brochure

La Belgique peut être fière de son rôle dans le domaine des études cliniques (études couvrant le processus de développement d’un nouveau médicament). Notre pays est en effet considéré comme un des meilleurs au monde. Et dire que 95% de nos concitoyens l’ignorent !

Ce vendredi 20 mai – Journée Internationale de l’Étude Clinique – sera l’occasion de donner à ces études la place qu’elles méritent aux yeux du grand public. La BeCRO (Association Belge des Contract Research Organisations), en collaboration avec les hôpitaux universitaires, organisera une distribution de fascicules destinés à informer les patients de l’existence des études cliniques, la possibilité d’y participer et leurs droits.

En point d’orgue de cette journée, le Professeur Frédéric Amant de UZ Leuven recevra une donation de la BeCRO pour financer ses travaux de recherche sur les cancers chez les femmes enceintes.

Communiqué de presse - Brochure

Brochure English

Medicines regulatory news

The MHRA has launched its new Notification Scheme for clinical trials today (1 April 2011) for medicinal products.

The Notification Scheme is available for trials involving medicinal products authorised in any EU Member State if:

• they relate to the licensed range of indications, dosage and form
• or, they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.

The Notification Scheme will be open to trials meeting the above criteria and may include randomisation of subjects to different marketed products or repackaging and/or relabelling of the marketed product(s). Placebo controlled trials will not be open to the notification scheme, nor will trials in which the marketed product has been modified, for example by over-encapsulation.

Following receipt of a valid notification submission, sponsors will receive an acknowledgement letter to say that the trial may go ahead after 14 days from receipt of the notification, if the MHRA has not raised any objections. This means that the acknowledgement letter will act as the authorisation.

If the MHRA raises an objection to the notification, the submission is treated as a standard request for authorisation and an assessment is carried out in the usual way with a time line of 30 days from the receipt of the original notification.

A risk assessment based on the potential risks associated with the use of the investigational medicinal product (IMP) should be made by the sponsor. Background documentation on how to do this is provided on the web site in the new section on the Notification Scheme.

This is the first part of the Medical Research Council (MRC) / Department of Health (DH) / MHRA Joint Project on Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products.

The second part of the project will provide guidance on risk-proportionate approaches to the management and monitoring of clinical trials. This will be available following the completion of the currently on-going pilot phase.

Clinical trials for medicines Notification Scheme