The Road Map Initiative

Members of the ELN/ELN-EC are involved in an initiative of EU-funded projects to give input in regulatory amendments. The ELN is focusing on problems of academical multinational resarch and therefor in part collaborating with this initiative. For further information have a look at the Initiative Overview.

A series of workshops will be conducted in the next month, starting with "A Single CTA in Multinational Clinical Trials Dream or Option?" on 7th july.

Initiative Overview

A Road Map for clinical research in Europe_Overview.pdf
A Road Map for clinical research in Europe_Workshop overview
Road Map Initiative Participants July 2009

First Workshop: Single CTA

Multidisciplinary Workshop on A Single CTA in Multinational Clinical Trials

The presentations of the first workshop are now available at the EFGCP-Website.
Please mark, these presentations are confidential to the EFGCP and you need a password. ELN-members are eligible for the download, but you have to inform the conference secretary about your request and membership (ELN).

Summary (263KB)
Summary for "A single CTA-Workshop"

Second Workshop: Co-Sponsoring

Road map initiative towards Co-sponsoring in the EU
Final Report_Co-Sponsorship Workshop_21Sept2009.pdf

3rd workshop

The 3rd workshop will take place in Barcelona, January 18, and focusing on an option for a risk-based approach in between the regulative framework.

Barcelona, 18th January 2010
Report: Risk based approach_ Barcelona_2010.pdf

4th workshop

Final Report Workshop on Ethical Review 19 Jan 2010.pdf

5th workshop: Towards A Better Future for Pharmacovigilance in Clinical Trials

This 5th workshop will take place on 8th February 2010 at the EORTC Headquarters in Brussels, Belgium. Please read also the invitation letter and the preliminary program.
Since the number of seats is limited, please confirm your participation at your earliest convenience before the 7th December 2009 by sending an E-mail to Mr. Lejeune (see below).
Please provide your affiliation and contact details. A confirmation email will be sent to you.

Please contact
Use the titel: "Invitation workshop pharmacovigilance in clinical trials"

Stephane Lejeune, MSc, MPH
European Organisation for Research and Treatment of Cancer
Tel: +32 (0)2 774 10 75
Fax:+32 (0)2 772 35 45

Pgm wshop on Pharmacovigilance in Clinical Trials-12Nov.pdf