Management and Evaluation of Therapeutic Trials GET

Our objective is to train executives in the field of Health by responding to the emerging demands and needs of the sectors of clinical evaluation of drugs, regulatory aspects of marketing and neuropsychology. Thus, we train for jobs in clinical research with industrial and academic outlets: Clinical Trial Coordinator, Clinical Research Associate, Quality Manager, Project Manager Physician or Pharmacist, Regulatory Affairs Manager and Clinical Research and Development Engineer.

In the field of neuropsychology, we offer opportunities including managers in charge of health studies, specialized research associate and manager in institutions for the care of the elderly.

In Master 1:

The training allows students to acquire a first specialization in one of the two fields related to each of the two Master 2 courses.

It provides the prerequisites in methodology, biostatistics, quality assessment and neurophysiology in one of the two areas of specialization: design, evaluation and management of therapeutic trials, neurophysiology and anatomy, necessary to acquire the dual competence with project management offered by the Masters 2 "Design, Evaluation and Management of Therapeutic Trials" and "R&D Neuropsychology".

In Master 2 :

The training completes the scientific and technological training acquired in Master 1 by giving the double competence in clinical development and the methodology necessary for a good and fast professional insertion of our young future executives in the industry or in the regulatory agencies and clinical research departments as well as in the aging professions. Our objective is to train executives in the field of Health, responding to the demands and emerging needs of the sectors of clinical evaluation of drugs, the regulatory aspect of marketing, both at the European and national levels. Valorization, the quality approach, preclinical development as well as phase 2/3 studies of drugs and biotherapies are addressed with professionals. The professionalizing character and the concern for the insertion of graduates in the public and private sectors are based on strong interactions between hospital services, researchers and neuropsychology professionals. There is no regional offer that ensures this double competence.

The aim of the Master 2 "R&D Neuropsychology" is to acquire a double competence in Neuropsychology and in Management and project management, thanks to a theoretical (fundamental and clinical) and practical training. This neuropsychology course will enable students to apply knowledge of the biological, neurophysiological, neuroanatomical and clinical foundations of normal and pathological cognitive and behavioral functioning to their professional practice in the fields of health care, medico-social care, research and industry, while mastering the techniques of project management and quality control. This training allows students to acquire a competence in research and development in neuropsychology, a competence that is now necessary for new job offers, linked to the increase in needs (aging population) and to the constant growth of certain activities (medico-social, health and pharmaceutical industries, service companies) in the field of cognition and behavior.

Upon completion of the internships and the "Design, Evaluation and Management of Therapeutic Trials" or "R&D Neuropsychology" training, students should be able to:

- Contribute to the design and preparation of a trial.

- Contribute to the writing of a clinical trial protocol.

- Prepare the regulatory file for biomedical research that will be submitted to the CPP and the competent authorities.

- Contribute to the management of a clinical trial - implementation and follow-up.

- Participate in the selection of centers, open and close centers in which biomedical research is conducted

- Evaluate the adequacy of the forecasted schedule, especially regarding the capacity of the inclusions

- Participate in the drafting of standard operating procedures (SOPs) and ensure compliance with GCP and the quality assurance system during a trial

- Manage study documents, create and update an investigator file in accordance with regulations

- Participate in the follow-up of the pharmacovigilance of a trial (declaration and follow-up of the G.I.E., management of the consequences on the course of the project)

- Participate in the coordination of multicenter studies

- Prepare data controls (audit or inspection)

- Archive study documents

- Contribute to the evaluation of a clinical trial

- Assessing a biomedical research project from a regulatory perspective

- Participate in the evaluation of the costs of biomedical research and prepare a research budget

- Critically analyze the methodology and results of an article reporting the results of a clinical trial

Objectives specific to the specialization: scientific and professional orientations of the training.

Educational objectives

Upon completion of the specialty, students should be able to:

- List the major sections of a clinical trial protocol

- Write a clinical trial protocol

- Argue the methodological options adopted in a clinical trial

- Specify the regulatory framework of a clinical trial

- Outline the clinical trial file that will be submitted to the PPC and the competent authorities

- Recall the principle and key points of GCP and a quality assurance system for a clinical trial.

- Explain the principle of pharmacovigilance in a clinical trial and describe the tools to evaluate it.

- Define the roles of the various players in a clinical trial

- Name the expense items in a research budget

- Evaluating the costs of biomedical research

- Analyze a biomedical research project from a regulatory perspective

- Critically analyze the methodology and results of an article reporting the results of a clinical trial

- Make a synthetic oral presentation of a clinical study protocol in French and English