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Yoani Matsakis, Conference Chair of the EUCROF Conference 2015, Board member of AFCROs (French Clinical Research Association), CEO of Telemedicine Technologies
Your 2nd European Conference on Clinical Research has just kicked off. Why did you choose the theme: “Regulations, technologies, risk management, data sources, patients' role ... Will reality match expectations?”
The new EU Clinical Trials Regulation will come into effect in 2016. The European Agency has also released a reflexion paper on risk based approach quality management. New perspectives for clinical research in children are also emerging and patients become actors. The late phase environment does not escape this era of changes.
Maintaining Europe’s position in the domain of clinical research is an essential challenge and these new pieces of regulations and best practices together with an endlessly evolving technology are creating opportunities and expectations. All stakeholders will be heavily impacted. They will have to adapt to this new environment and the question whether, in practice, reality will match expectations is clearly posed in a context where the pressure of change is multifactorial.
One objective of the conference is precisely to review and compare all points of view, to facilitate interactions between stakeholders, propose a prospective review of the main factors that will significantly influence how clinical research will be conducted in the coming decade and consider propositions or recommendations on how stakeholders in the EU shall anticipate such changes.
How important is your conference in a changing regulatory environment?
A few months after the official publication of the new EU Regulation, this conference comes at a perfect point in time for all stakeholders to better anticipate the required changes. Our conference will be a unique moment where the content of the Regulation – in the meantime probably more or less known by the audience – will be exposed, analysed and discussed by key representatives of all stakeholders: regulators, ethic committees, pharmaceutical industry, CROs, academia, patients associations will delineate the lowlights and highlights of the Regulation from their particular point of view.
For your the EUCROF Conference 2015 you have chosen Paris and Les Salons Hoche – Conference venue. Why?
Paris is not just a magic city where something is always happening, it is also a very important place for Clinical Research in Europe with dynamic CROs companies providing a high quality service. The European Conference on Clinical Research is organized by EUCROF with the support of the local association members. The 1st event took place in Brussels, heart of Europe, in October 2013 and the French Association of CROs, AFCROs, proposed to co-organize this second edition in Paris. Salons Hoche were chosen as a very central and prestigious place where AFCROs is used to organizing its successful yearly conference on clinical research.
For those delegates who cannot join you in Paris. Can they participate remotely?
No, but most of the presentations will be available on-line on the Conference website and we have a very informative programme book that is also available for download.
What are the main challenges for EUCROF (the European CRO Federation) these days?
EUCROF has been in existence for 10 years. It consists of members and associated members from 17 countries and stands for 300 member CROs and over 20.000 employees. Its two main challenges and achievements are
+ to help its members have a better vision and understanding of the future of clinical research in Europe, and to face successfully new challenges with the most appropriates responses and competitiveness
+ in close cooperation with all other stakeholders promote a global vision of European clinical research as a dynamic economic sector whose central objective is to discover and develop new therapeutic solutions for human health, with a high quality of services, scientific knowledge and ethical responsibility.
+ EUCROF actively collaborates in the EMA Working Group on the new Clinical Trial Portal, with the EMA Working Group on Paediatric Clinical Research and has recently entered the list of stakeholders admitted to the European Parliament.
Founded in 2005 EUCROF, the European Contract/Clinical Research Organisations (CRO) Federation, promotes Clinical Research by improving the knowledge, competence and skills of CROs in Europe. The non-profit organisation represents and supports the interests of CROs in Europe, towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare related industry within the field of clinical research, as well as the medical and affiliated research community. EUCROF participates in international congresses, organizes supporting training and educational programmes and the 2nd European Conference on Clinical Research from 2 to 4 February 2015 in Paris. www.eucrof.eu, www.eucrof-conference.eu