ECTS
120 credits
Duration
2 years
Training Structure
School of Medicine
Overview
Objectives
Our goal is to train professionals in the health care field by addressing the emerging demands and needs of the sectors of clinical drug evaluation, regulatory aspects of market authorization, and neuropsychology. Thus, we provide training for careers in clinical research with opportunities in both industry and academia, including: Clinical Trial Coordinator, Clinical Research Associate, Quality Manager, Physician or Pharmacist Project Manager, Regulatory Affairs Manager, and Clinical Research and Development Engineer.
In the field of neuropsychology, we offer career opportunities such as health research coordinators, specialized research associates, and managers at facilities that provide care and support for the elderly.
Expertise and Skills
In the first year of the Master's program:
The program allows students to acquire an initial specialization in one of the two fields associated with each of the two tracks of the Master 2 program.
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; and neurophysiology and anatomy—which are necessary to acquire the dual expertise in project management offered by the Master’s 2 programs in “Design, Evaluation, and Management of Clinical Trials” and “R&D in Neuropsychology.”
In the second year of the Master's program:
The program complements the scientific and technological training acquired in the first year of the Master’s program by providing dual expertise in clinical development and the methodology necessary for our young future executives to quickly and successfully enter the workforce in industry, regulatory agencies, clinical research departments, and fields related to aging. Our goal is to train executives in the health sector who can meet the emerging demands and needs of the fields of clinical drug evaluation and the regulatory aspects of market authorization, at both the European and national levels. Drug development, quality assurance, preclinical development, and Phase 2/3 clinical trials for drugs and biotherapies are addressed in collaboration with industry professionals. The program’s career-oriented focus and commitment to helping graduates secure positions in both the public and private sectors are built on strong collaboration between hospital departments, researchers, and neuropsychology professionals. No other regional program offers this dual expertise.
The Master 2 program in “R&D in Neuropsychology” is designed to provide students with dual expertise in neuropsychology and management and project management through a combination of theoretical (fundamental and clinical) and practical training. This neuropsychology program will enable students to apply 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 program enables students to acquire expertise in research and development in neuropsychology—a skill now essential for new job opportunities arising from increasing needs (due to an aging population) and the steady growth of certain sectors (medical-social services, healthcare, the pharmaceutical industry, and service providers) in the field of cognition and behavior.
Upon completion of the internships and the “Design, Evaluation, and Management of Clinical Trials” or “Neuropsychology R&D” course, students should be able to:
- Help design and prepare a trial.
- Help draft the protocol for a clinical trial.
- Prepare the regulatory documentation for a biomedical research project to be submitted to the CPP and the relevant authorities.
- Assist in the management of a clinical trial—setup and monitoring.
- Participate in the selection of sites; open and close sites where biomedical research is being conducted
- Assess the adequacy of the tentative schedule, particularly with regard to the capacity of the inclusions
- Help draft standard operating procedures (SOPs) and ensure compliance with Good Clinical Practice (GCP) and the quality assurance system during a clinical trial
- Manage study documents; create and update an investigator's file in accordance with regulations
- Assist with pharmacovigilance monitoring for a clinical trial (reporting and monitoring of serious adverse events, managing the impact on the trial’s progress)
- Help coordinate multicenter studies
- Prepare for data reviews (audits or inspections)
- File the study documents
- Help evaluate a clinical trial
- Conduct a regulatory review of a biomedical research project
- Help estimate the costs of a biomedical research project and prepare a research budget
- Critically analyze the methodology and results of an article reporting the findings of a clinical trial
The program's specific objectives: the program's academic and career focus.
Learning Objectives
Upon completion of the specialization, students should be able to:
- List the main sections of a clinical trial protocol
- Draft a clinical trial protocol
- Justify the methodological choices made in a clinical trial
- Specify the regulatory framework for a clinical trial
- Outline the main points of the clinical trial application to be submitted to the CPP and the relevant authorities
- Review the principles and key points of Good Clinical Practice (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 expense categories in a research budget
- Estimate 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 findings 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 earned an overall grade point average of 10/20 or higher for both Semester 1 and Semester 2 are considered admitted to the Master’s 1 (M1) program.
- Semester 1: All course units (CUs) count toward each other.
- Semester 2: The internship must be approved separately.
Semester S1 and Semester S2 do not offset each other.
SEMESTER 3: Successful completion of Semester 3 requires passing 5 required course units (UE) and the hospital internship. All course units (UE) are weighted equally. If a student fails the first exam session (cross-disciplinary course units with a grade below 10/20 and/or elective course units with a grade below 10/20), students must sit for mandatory written exams at the end of August of the current academic year, exclusively in the subjects in which their grades were below 10/20 during thesecond exam session (make-up exams).
SEMESTER 4: 6-month internship (30 ECTS)
The internship validation exam includes the following grading criteria:
- 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 of the course of 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 a general understanding of the various stages of clinical research (clinical trial design, statistical methodology), regulatory aspects, and the fundamentals of neuropsychology. This body of knowledge will prepare students to specialize in one of two sectors of the healthcare and biomedical research industries during Semester 2, with significant input from industry 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 the evaluation and methodology of therapeutic trials required for the Master’s 2 programs in “Design, Evaluation, and Management of Therapeutic Trials” and “Neuropsychology.”
MASTER 2:
This specialty enables students to develop methodological, clinical, and research project management skills, as well as skills in:
- Design, Evaluation, and Management of Clinical Trials
- R&D in Neuropsychology
Select a program
Master's 1 - GET, Neuropsychiatry Track
Choose one: 1 out of 1
Current Research in Immunology
5 credits
Introduction to Careers in Clinical Research
5 creditsNeurobiology of Behavior
5 creditsDevelopmental Neurobiology
5 creditsNeuropsychopharmacology
5 creditsApplied Statistics in Biology
5 credits
English_FdM
5 creditsTER_FdM
5 creditsInternship_FdM
15 credits
Master 2 - GET, Neuropsychiatry Track
Project Management and Planning
5 creditsResearch in Neuropsychology: Topics and Methods
5 creditsNormal and Pathological Cognitive Functioning in Adults
5 creditsTranslational Research & Clinical Evaluation of Biotherapeutics
5 creditsNormal and Abnormal Cognitive Functioning in Children
5 creditsRegulatory Affairs and Quality Assurance
5 credits
GET Internship
30 credits
Master's 1 - GET, Innovative Therapy Track
Introduction to Careers in Clinical Research
5 creditsApplied Statistics in Biology
5 creditsPhysiology and Integrated Homeostasis
5 creditsCHOICE 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, Innovative Therapy Track
GET Internship
30 credits
Admission
Registration Procedures
Apply for the first year of the master's program in " https://www.monmaster.gouv.fr/candidater-1"
Apply to the Master 2 in " https://candidature.umontpellier.fr/candidature/#"! Home View