The European Federation of CROs is pleased to invite you to the forthcoming European Pharmaceutical Pre-Conference and Conference that will be held in Brussels from 7-9 October 2013.
This event will provide a unique opportunity to hear from worldwide expert speakers from Regional and National Authorities, Pharmaceutical Industry and global CROs and will be of interest to all actors engaged in clinical research, with a primary focus on the European region.
The Pre-Conference on "Clinical Outsourcing: Converting Promise to Delivery" will be organised on 7 October 2013.
In the 1980s, pharmaceutical companies began outsourcing their research and development and drug testing trials to CROs. CROs promised increased efficiency, cost savings and technological innovations through greater focus.
In the early 2000s, pharmaceutical companies looking once again for cost efficiencies in R&D started outsourcing specific functions which were either deemed non-core or not adding to competitive advantage to external service providers. Apart from CROs, a number of IT and business process service providers started thus entered the industry.
Today, outsourcing of different forms is accepted and widely prevalent within the industry. Outsourcing has been seen as a strategy to not only get efficiencies but also to bring flexibility in resourcing and gain access to talent across the world.
But how far has outsourcing delivered on its promise? The aim of this preconference is to provide a balanced interactive forum for representative “stakeholders” working in clinical research and development from pharmaceutical companies and outsourcing service providers. In 3 sessions, we will share information and insight from outsourcing practices and provide direction to strategic thinking on outsourcing for the future.
The main Conference on 8-9 October 2013 will address multiple facets of this highly evolving environment, considering how clinical research is responding to the global landscape, stressing the specific challenges and strengths which characterise the three main regions being the Americas, Europe and Asia.
A series of regulations and guidances will shortly reshape the clinical research landscape in Europe. Expert speakers will provide insight in the essential features of these new frameworks. We will review how the future Clinical Trial Regulation will transform access to Clinical Trials in Europe, also hearing from National Agencies and Ethic Committees preparing for this ambitious change. Risk based Quality Management will also be a point of focus, balancing expectations from the regulators and the perspective of Pharmaceutical Companies facing challenges on the implementation pathway.
We will critically assess how the fast changing digital technologies may offer opportunities for innovative ways of delivering Clinical trials, considering inherent risks and challenges associated with them.
The Patient Associations will join this conference to highlight the most significant barriers to a prosperous clinical research.
Michèle Garot & Philippe Van der Hofstadt
Chairs of the EUCROF Conference 2013