Clinical Trial Strategy and Regulatory Approval


Thu, 07/03/2008 - Sat, 07/05/2008


SIMS Biotech Executive Programme
Module IV



As time passes, finding new products for the market is becoming more dificult, Module IV from the SIMS Programme, which will take place 3 to 5 July in Barcelona, offers the opportunity to meet experts from Europe and  the United States in Clinical Trial Strategy and Regulatory Approval 

During those three days, attendees will learn the approach that they will have to make in clinical studies and regulatory approvals.  The advice and study of practical cases cover from pre-clinical matters and clinical quality standards to the budget making, and the CRO and civil services relations.

Teachers for this course about clinical studies and regulatory approvals count with experts from Europe and the United States such as Jennie Sykes from GSK; Damian O'Connell from Pfizer; Christian Elling from 7TM Pharmaceuticals; Piet Wiegerinck from Galapagos; Remy Luthringer from Forenap Pharma and Carlo Zanotti from Cellerix.  The programme manager is José Carlos Gutiérrez-Ramos, (senior vice-president of inflammation research from GSK).  Previously, he was a scientific manager and boss in Amgen and ex-vice-president of Inflammation from Millenium Pharmaceuticals.

The course, organized by Biocat, the BioRegión of Cataluña, the Parque de Investigación Biomédica of Barcelona (PRBB) and the Instittuto de Educación Continua (IDEC) of Popeu Fabra University, has filled the existing gap in the education of young experts in biotechnology and experts in technology transfer, through the combination of high level  apprenticeship concept through partners and the teaching staff.

Registration can be done through the Biocat website:

Workshop Programme






Esta página web se realizó en 2009 con apoyo financiero del Ministerio de Ciencia e Innovación y de los Fondos FEDER. Dentro del PN de investigación Científica, Desarrollo e Innovación Tecnológica 2008-2011. Ref. RET-90000-2008-001