ECTS
120 credits
Duration
2 years
Training structure
School of Medicine
Presentation
For more information on the Master's Degree in Management and Evaluation of Therapeutic Trials (GET)
Objectives
Our goal is to train executives in the field of healthcare by responding to emerging demands and needs in the areas of clinical drug evaluation, regulatory aspects of market launch, and neuropsychology. We therefore provide training in clinical research professions with industrial and academic career opportunities: 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 career opportunities including health research executives, specialized research assistants, and managers in elderly care facilities.
Know-how and skills
In Master 1:
The program allows students to acquire an initial specialization in one of the two areas related to each of the two Master 2 tracks.
It provides the prerequisites in methodology, biostatistics, quality assessment, and neurophysiology in one of two areas of specialization: design, evaluation, and management of therapeutic trials, neurophysiology and anatomy, necessary to acquire dual expertise with project management offered by the Master's 2 programs in "Therapeutic Trial Design, Evaluation and Management of Therapeutic Trials" and "Neuropsychology R&D."
In Master 2:
The program complements the scientific and technological training acquired in Master 1 by providing dual expertise in clinical development and the methodology necessary for the successful and rapid professional integration of our young future executives into industry or regulatory agencies and clinical research departments, as well as professions related to aging. Our goal is to train executives in the field of health, responding to the emerging demands and needs of the sectors of clinical drug evaluation and the regulatory aspects of marketing, both at the European and national levels. Valorization, quality assurance, preclinical development, and phase 2/3 studies of drugs and biotherapies are addressed with professionals. The professional nature of the program and the focus on placing graduates in the public and private sectors are based on strong interactions between hospital departments, researchers, and neuropsychology professionals. There is no other regional program that offers this dual expertise.
The Master 2 program in Neuropsychology R&D aims to provide students with dual expertise in neuropsychology and project management through theoretical (fundamental and clinical) and practical training. This neuropsychology program will enable students to apply their knowledge of the biological, neurophysiological, neuroanatomical, and clinical foundations of normal and pathological cognitive and behavioral functioning to professional practice in the fields of healthcare, medical-social services, research, and industry, while mastering project management and quality control techniques. This training program enables students to acquire skills in neuropsychology research and development, which are now necessary for new job opportunities linked to increasing needs (aging population) and the constant growth of certain activities (medical-social, healthcare and pharmaceutical industry, service providers) in the field of cognition and behavior.
Upon completion of the internships and training courses in "Design, Evaluation, and Management of Therapeutic Trials" or "Neuropsychology R&D," students should be able to:
- Contribute to the design and preparation of a trial.
- Contribute to the drafting of a clinical trial protocol.
- Prepare the regulatory dossier for biomedical research to be submitted to the CPP and the competent authorities.
- Contribute to the management of a clinical trial - implementation and monitoring.
- Participate in the selection of centers, open and close centers where biomedical research is conducted
- Assess the adequacy of the provisional schedule, particularly with regard to inclusion capacity.
- Participate in drafting standard operating procedures (SOPs) and ensure compliance with GCP and the quality assurance system during a trial.
- Manage study documents, compile and update an investigator's folder in accordance with regulations
- Participate in the pharmacovigilance monitoring of a trial (reporting and monitoring of serious adverse events, managing the impact on the progress of the project)
- Participate in the coordination of multicenter studies
- Prepare data checks (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 biomedical research costs and prepare a research budget
- Critically analyze the methodology and results of an article reporting the results of a clinical trial
Specific objectives of the specialty: scientific and professional orientations of the training program.
Educational objectives
Upon completion of the specialization, students should be able to:
- List the main sections of a clinical trial protocol
- Write a clinical trial protocol
- Justify the methodological options adopted in a clinical trial
- Specify the regulatory framework for a clinical trial
- Outline the main points of the clinical trial dossier to be submitted to the CPP and the competent authorities.
- Review the principle and key points of GCP and a quality assurance system in the context of a clinical trial.
- Explain the principle of pharmacovigilance in a clinical trial and describe the tools used to evaluate it.
- Define the roles of the various participants in a clinical trial
- List the expenditure items in a research budget.
- Evaluate 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
- Give a concise oral presentation of a clinical study protocol in French and English
Organization
Knowledge assessment
SEMESTER 1 and SEMESTER 2: Students who have obtained an overall average of 10/20 or higher for Semester 1 and Semester 2 are admitted to Master 1 (M1).
- Semester 1: all teaching units (UE) are mutually compensatory.
- Semester 2: The internship must be validated independently.
Semester S1 and semester S2 do not offset each other.
SEMESTER 3: To pass semester 3, students must complete 5 compulsory teaching units (UE) and the hospital internship. All teaching units (UE) are mutually compensatory. In the event of failure in the first session (cross-disciplinary teaching units below 10/20 and/or teaching units relating to options below 10/20), students must sit compulsory written exams at the end of August of the current academic year, and only in those subjects in which their marks were below 10/20 in thesecond session (resit).
SEMESTER 4: Six-month internship in a company (30 ECTS)
The internship validation exam includes the following grades:
- a written internship report (/90) – 9 ECTS,
- an internship evaluation form completed by the supervisor (/90) – 9 ECTS,
- an oral exam (/120) – 12 ECTS. It includes a discussion about the internship and the knowledge acquired.
Semester S3 and semester S4 do not offset each other.
Program
MASTER 1:
The courses in Semester 1 provide students with general knowledge of the various stages of clinical research (clinical trial design, statistical methodology), regulatory aspects, and the main principles of neuropsychology. This knowledge will enable students to tackle a specialization in one of two sectors of the health and biomedical research industries in semester 2, with significant input from professionals: a. Design, Evaluation, and Management of Therapeutic Trials, b. Neuropsychology R&D. The two semesters of the Master's 1 program provide students with the prerequisites in methodology, biostatistics, quality assessment, and therapeutic trial assessment and methodology necessary for the Master's 2 program in "Therapeutic Trial Design, Evaluation, and Management" and "Neuropsychology."
MASTER 2:
The specialization allows students to acquire methodological, clinical, and research project management skills, as well as skills in:
- Design, Evaluation, and Management of Therapeutic Trials
- R&D Neuropsychology
Select a program
Master's Degree - GET in Neuropsychiatry
Choose 1 from 1
Current research in immunology
5 credits
Introduction to careers in clinical research
5 creditsNeurobiology of behavior
5 creditsDevelopmental neurobiology
5 creditsNeuropsychopharmacology
5 creditsStatistics applied to biology
5 credits
English_FdM
5 creditsTER_FdM
5 creditsInternship_FdM
15 credits
Master's Degree - GET with a specialization in Neuropsychiatry
Project management and planning
5 creditsResearch in Neuropsychology: Topics and Methods
5 creditsNormal and pathological cognitive functioning in adults
5 creditsTranslational Research & Clinical Evaluation Biotherapy
5 creditsNormal and pathological cognitive functioning in children
5 creditsRegulatory Affairs and Quality Assurance
5 credits
GET internship
30 credits
Master 1 - GET in Innovative Therapy
Introduction to careers in clinical research
5 creditsStatistics applied to biology
5 creditsPhysiology and Integrated Homeostasis
5 creditsOPTION 1
5 creditsCellular communications and signaling
5 creditsFunctional exploration and translational research
5 credits
English_FdM
5 creditsTER_FdM
5 creditsInternship_FdM
15 credits
Master 2 - GET in Innovative Therapy
GET internship
30 credits
Admission
Registration procedures
Apply for the Master 1 programhttps://www.monmaster.gouv.fr/candidater-1
Apply for the Master 2https://candidature.umontpellier.fr/candidature/# home View