Yannick BARDIE

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Experiences

Imagining the future….
Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”
History goes on, it will continue….
At this time of globalisation of the development of health products, accessing healthcare as a human fundamental right is a question to be considered. The right to live, to remain healthy and to have body integrity are seen as essential capabilities.
(A. Sen.; M. Nussbaum).
The clinical trial permits an access to free healthcare and in certain developing countries this is the only option available. However no restrictive international regulation exists in clinical research.
Rules founding human cooperation are changing. It is a question of justice and the conception of a global development project is at stake. This project must be shared, for example, the essential requirements must not be to the detriment of a large part of humanity or of the future generations. (A.Sen. by Filipo).
The potential development of a Sustainable Global Clinic, in which the increasing role of the “supervisors” could prove to be useful and necessary in the prevention of an “ethical risk”. (supervising agencies/committees)
2008 : RD clinique SAS is the sponsor of a clinical trial on artificial pancreas
2007 : RD clinique become a franchise of QED system www.qed-clinical.com in France
2000-2007 : 1st implantation of an artificial pancreas (study follow-up for 7 years)

Education

Project : Data analysis and pharmaceutical security

Validation of learning by experiences : Speciality Clinical operation Management and data management

Clinical Development

Interests

Skills

English : fluent
Spanish : good skills
Italian : understanding
Catalan : understanding

Specialities : thrombosis, cardiovascular diseases, vaccins, urology, hepatology, lung cancer, medical imaging,obesity, anorexia, bulimia, oncology, neurology, diabetes
Managment of clinical operations:
- coordination of CRAs and trainees
- conduct of Investigator meeting
- conduct of monitoring visits (site selection, kick off, monitoring, close-out)
Communication with sponsors, investigators and competent authorities
Quality assurance, compliance with GCP-ICH and concerned regulations
Planning (project, ressources)
Logistics

Project management and planification
Point of view on the evolution of the clinical research in France and in the world. The opportunity of a reflection on a job which reaches maturity, at the age of reason and on a sector which globalizes and becomes industrialized. The opportunity of a debate also. Every public, 2 hours with questions answers and debate.
The European directive 2001/20/CE on Clinical trials
Health Marketing
Specific product in development (blood components, medical devices)
Role-playing workshop ( investigator meeting, inititation, monitoring and close-out visits)
Professional training on the regulations for medical devices

Clinical evaluation of performance and safety data of medical devices via a literature review according to the guide MEDDEV 2.7.1 rev3

Clinical Research expert