Program Overview

Introduction to the Master's Degree in Management and Evaluation of Therapeutic Trials

The Master's Degree in Management and Evaluation of Therapeutic Trials (GET) is a comprehensive program designed to train executives in the field of healthcare. The program responds to emerging demands and needs in the areas of clinical drug evaluation, regulatory aspects of market launch, and neuropsychology.

Program Objectives

The primary objective of the program is to provide training in clinical research professions with industrial and academic career opportunities. These opportunities include:

• Clinical Trial Coordinator
• Clinical Research Associate
• Quality Manager
• Project Manager Physician or Pharmacist
• Regulatory Affairs Manager
• Clinical Research and Development Engineer In the field of neuropsychology, the program offers career opportunities such as health research executives, specialized research assistants, and managers in elderly care facilities.

Program Structure

The program is divided into two years, with 120 ECTS credits. It is structured into two main parts: Master 1 and Master 2.

Master 1

Master 1 provides students with an initial specialization in one of the two areas related to each of the two Master 2 tracks. It offers 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 This dual expertise is necessary for acquiring project management skills offered by the Master's 2 programs in "Therapeutic Trial Design, Evaluation and Management of Therapeutic Trials" and "Neuropsychology R&D."

Master 2

Master 2 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 young executives into industry or regulatory agencies and clinical research departments, as well as professions related to aging. The program focuses on:

• Valorization
• Quality assurance
• Preclinical development
• Phase 2/3 studies of drugs and biotherapies These areas are addressed with professionals, ensuring a strong interaction between hospital departments, researchers, and neuropsychology professionals.

Training Summary

The program requires an entry level of no specific study program, offering both continuing education and initial training. The training summary includes:

• Semester 1 and Semester 2: Students must obtain an overall average of 10/20 or higher to be admitted to Master 1.
• Semester 3: Students must complete 5 compulsory teaching units and a hospital internship.
• Semester 4: A six-month internship in a company (30 ECTS) is required, with an internship validation exam.

Educational Objectives

Upon completion of the specialization, 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
• Contribute to the management of a clinical trial
• Participate in the selection of centers and assess the adequacy of the provisional schedule
• Participate in drafting standard operating procedures (SOPs) and ensure compliance with GCP and the quality assurance system
• Manage study documents and participate in pharmacovigilance monitoring
• Prepare data checks and archive study documents
• Contribute to the evaluation of a clinical trial
• Assess a biomedical research project from a regulatory perspective
• Critically analyze the methodology and results of an article reporting the results of a clinical trial

Specific Objectives of the Specialty

The specific objectives of the specialty include scientific and professional orientations of the training program. 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
• Review the principle and key points of GCP and a quality assurance system
• Explain the principle of pharmacovigilance 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.