1997 - 2007 Celebrating 10 years of ERIQA Group Bernard Jambon 1| Neil Aaronson 2 1 Mapi Research Trust, Lyon, France 2 PhD, The Netherlands Cancer Institute, Amsterdam, The Netherlands

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November 2007 marks the 10th anniversary of the European Regulatory Issues on Quality of Life Assessment Group (ERIQA), whose main objectives are to inform and train European regulators on HRQoL as a relevant outcome and a credible criterion in the evaluation of medicines, as well as to provide them with support on how to evaluate HRQoL studies in clinical trials and the validity of HRQoL claims. Since its creation the group, coordinated by Mapi Research Trust, has met on a bi-annual basis bringing together key players from academia, industry and the health authorities.

HRQoL and PRO training programs

Since 2002 ERIQA has organized training sessions for the FDA, EMEA and the national authorities of several European countries (see table below). The overall aim of the program is to facilitate the understanding of key concepts of HRQoLand PRO. The one-day-sessions are free of charge and are tailored to the needs of the attendees whose work may be in the following fields: pre- or post authorization process of medicines for human use, the evaluation of safety and efficacy of medicine’s post-authorization, pharmacovigilance, health insurance boards, pricing and reimbursement.

The following two aspects constitute the major focus of the present training initiative:

1. “PRO in the light of the FDA draft guidance and the EMEA reflection paper”

2. Patient-Reported Outcomes in clinical trials and cost effectiveness data from observational Studies

For more information please consult the ERIQA’s website www.eriqa-project.com/training-sessions.php .