MODM Clinical Database Management

Number of ECTS credits = 5 –TU CoordinatorTU  Béatrice BAÑULS

Essential Prerequisites:
Introduction to Law is recommended but not required
: The Essential Principles of Quality Management

Marketing
Understand the role of marketing and its analytical aspects (various market research studies)

Financial Analysis
Have a basic understanding of the company’s financial statements and the role of the relevant line items (balance sheet and income statement).

Content and Objectives ofTU

Pharmaceutical Law(18 hours of lectures shared with the Master’s in Pharmaceutical Sciences)
Legal Framework for Medicines (1 hour)
Health Products: Concepts and Regulations (1 hour)
Pharmaceutical Companies (2 hours)
Marketing Authorization in the European Union (specific medicines) (3 hours)
Marketing Authorization Outside TU CTD (3 hours)
Pharmacovigilance (2H)
Reimbursement Prices (2H)
Advertising (2H)
Industrial Property (2H)
Understand the various laws applicable to the pharmaceutical sector, their origin, their legal standing, and how they interrelate.
Understand the concepts related to different healthcare products
Understand the fundamentals of the regulatory framework governing the protection of innovation, manufacturing, marketing authorization, and the monitoring of drugs

Marketing: 9:00 a.m. Lecture
The Comprehensive Marketing Approach
A Review of Market Research
Diagnostic Tools and Strategic Planning
Integrating the Comprehensive Marketing Approach
Understanding Diagnostic Tools and Strategic Directions

Financial Analysis: 6 hours of lectures + 3 hours of tutorials
Introduction to Financial Analysis
Principles of Comparative Analysis
Different Ratios: Financial, Economic, and Cash Flow
Be able to analyze the profitability, solvency, and liquidity of a business (industrial company).

Quality Management: 12 lecture hours + 3 lab hours (shared with the Master’s in Pharmaceutical Sciences, except for Course 3)
In the context of quality management in a business setting, based on best practices and ISO standards:
1. Review of the fundamentals of quality systems, organizational structure, and documentation in a business setting (3 hours)
2. Quality Control and Quality Assurance (2 hours)
3. Qualification and Validation: Control of equipment, software, and production processes (2 sessions of 1.5 hours each—for the IS Master’s program only)
4. Management of deviations and nonconformities (2 hours)
5. Continuous improvement: Corrective and preventive actions (2 hours)
3-hour tutorial: Nonconformity – CAPA

Safety: 6 hours of classroom instruction
Introduction to ICPEs
Corporate Social Responsibility: Protection of Workers and the Environment
Safety Data Sheets and Classification of Hazardous Substances and Products: Key Elements of CSR

Teaching Methods:
Marketing and Financial Analysis
Courses that encourage student interaction through the content and examples provided.
Specific questions on each of the topics covered.

Number of ECTS credits = 5 – TU Coordinators TU  Hélène FENET – Aurélie ESCANDE – Patrice RAVEL

Epidemiology:Health indicators; descriptive, etiological, and evaluative epidemiology
Health and Environment:The structure of public health; national and regional management of environmental health through public health plans; corporate social responsibility; the characteristics and behavior of various types of pollutants posing environmental and health risks; examples of contaminants that pose health risks.
Databases:Relational model, simple SQL queries, creating tables, managing constraints, importing data, creating forms, creating reports, creating macros, and using VBA in ACCESS™

Students must acquire the skills to be able to
→Understandepidemiological studies:
Identify epidemiology as a public health tool
Understand the tools of epidemiological surveillance
Understand the different types of epidemiological studies
Be able to interpret descriptive epidemiology indicators
Be able to calculate and interpret risk ratios (RR and OR) derived from analytical epidemiology
Be able to describe and critically evaluate the strategies, study protocols used in epidemiology
Be able to evaluate the validity of screening tests
→Understandthe behavior and health impacts of pollutants, as well as the management tools provided by legislation (through examples)
Explore public health management in France,
Be able to identify key issues in environmental health
→Learnthe basics of database management
Understand how information is structured using the relational model
Recognize the different ways databases are used (administrator/client)
Learn how to build a database consisting of several tables
Be able to define the main constraints on a database
Be able to use the main SQL commands
Be able to work independently with the ACCESS (Microsoft) database management system

Number of ECTS credits = 5 –TU CoordinatorTU  Xavier GARRIC

Essential prerequisites: General knowledge of biology, chemistry, and pharmaceutical technology

TU Content and ObjectivesTU 44 hours C

Health Products and Industrial Environment Development Strategy: 29 hours of lectures:

• General knowledge of the pharmaceutical, cosmetics, and medical device sectors
• Knowledge of the regulatory and socioeconomic characteristics of the pharmaceutical, cosmetics, and medical device sectors
• Ethics in healthcare
• Operations and corporate culture in the healthcare sector

Project Management: 3-hour lecture
• Introduction to Project Management for Healthcare Product Development

Clinical Development: 12-hour lecture series
• Introduction to the conduct of clinical trials in accordance with Good Clinical Practice (GCP)
• Drug development
• Clinical trial methodology
• The standard outline of a clinical trial protocol

Teaching methods:
Lectures focused on making complex concepts accessible, with an emphasis on interaction with students
Tutorials using computer-based project management tools

Number of ECTS credits = 5 –TU CoordinatorsTU  Armelle CHOQUET & Arnault GRAINDORGE

Essential prerequisite:Knowledge of molecular and cellular biology (L3 level)

TU Content and ObjectivesTU 22 hours of lectures + 6 hours of seminars + 22 hours of lab work

CM
• Identification of molecular or cellular targets (Introduction = 2 hours, -omics approaches = 2 hours) and concepts of biomarkers = 2 hours (6 hours)
• Recombinant DNA technology = 2 hours, CRISPR-Cas = 2 hours, synthetic biology (2 hours): (6 hours)
• Industrial applications/examples: proteins, antibodies, and vaccines (5 hours); optimization of biopharmaceuticals (2 hours), contemporary biotechnologies (3 hours). (10 hours)
Lab
• Recombinant DNA, virtual cloning (6 hours)

Lab
• Lab 1 => Cloning, production, purification, and characterization of a recombinant protein (12 hours)
• Lab 2 => Establishment of a cellular model for mid-throughput screening (10 hours)

Objectives:
Learn about the various health products derived from biotechnology
Gain an understanding of therapeutic targets and biomarkers
Gain an understanding of medium- and high-throughput screening
Learn about recombinant DNA technologies, molecular biology, and synthetic biology
Gain a practical overview of the conditions for producing a recombinant protein and developing a cellular model compatible with medium-throughput screening (through hands-on laboratory work).

Teaching Methods:
The format of this TU, which focuses heavily on hands-on workshops and examples, should enable students to gain a fairly clear understanding of the use of biotechnology in the fields of healthcare and industry in general.

Number of ECTS credits = 5 – TU CoordinatorsTU Gregory NICKSON and Béatrice BANULS

Essential prerequisite: High school diploma

TU Content and ObjectivesTU
Modern Languages: 40 hours of tutorials
Develop communication skills in a foreign language.
Specialized vocabulary.
Knowledge of businesses and health issues in countries where the target language is spoken.
Cultural perspective.

Communication: 9:00 a.m. Tutorial
Learning to work as part of a team and find one’s place within a group.
The concept of group dynamics and team cohesion.
Communicating effectively, listening actively, and sharing ideas (techniques, methods, and networks).
Building constructive professional relationships (attitudes and behaviors); collaboration and consultation.
Negotiation techniques

Tutorial Bibliography: 3-hour tutorial
Know how to use the bibliographic resources of a university library
Know how to compile a relevant bibliography related to scientific topics

Teaching Methods:
Mock job interviews, oral presentations with PowerPoint, mock meetings, writing letters and emails, debates, reading documents, etc.
Practical exercises focusing on various skills (reading, writing, and speaking)
TOEIC preparation
Methodological aspects (based on the group’s needs)
Exercises on a digital platform designed to review and reinforce language skills.

Communication: tests, exercises, role-playing

Number of ECTS credits = 5 – TU Coordinator TU  Patrice Ravel

Essential prerequisites:Physiology Course(Bachelor’s degree), Understanding the process of a clinical trial

Course Details:   43.5 hours of lectures + 6 hours of tutorials

Objectives

• To provide students pursuing careers in clinical research with a basic understanding of the various therapeutic areas that are the subject of clinical studies
• Understanding the Pharmacokinetic Profile
• Knowing how to present yourself verbally and in writing

CONTENTS of theTU

THERAPEUTIC APPROACHES

Oncology, Cardiovascular, CNS, Pulmonology, Thrombosis, Diabetes, Hypertension, Hematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectious Diseases, Vaccine Trials, Medical Device Trials

PHARMACOKINETICS

Definition of the key variables involved in the conduct of Phase 1 clinical development

PEC
Oral presentations by English and French students
CV and cover letter review

Teaching Methods:
Lectures and tutorials

Number of ECTS credits = 10 – TU Coordinator TU Béatrice BAÑULS

Essential prerequisite:
Have completed at least one internship during the Bachelor’s program
TU the first yearTU the Master’s program, both core and track-specific

Content and Objectives ofTU

2-hour class: preparation and guidelines for finding and completing an internship

3 to 5 months of full-time work experience at a public or private company.
Apply the knowledge acquired during the training program
Carry out a concrete professional project within the context of the company’s operations

Teaching Methods:

Written report, Oral exam, Evaluation by the internship supervisor

Number of ECTS credits = 5 – 

TU ManagerTU  Caroline WEMYSS and Peter WEINMANN

Essential prerequisite: High schooldiploma

Content and Objectives ofTU 

Development of all communication skills: written and oral expression and comprehension
Knowledge of the international professional and cultural environment
Mock job interviews, oral presentations with PowerPoint, mock meetings, writing letters and emails, debates, reading documents, etc.
Methodological aspects (based on the groups’ needs)
Exercises on a digital platform designed to review and reinforce language proficiency.
Developing communication skills in a foreign language.
Specialized vocabulary
Knowledge of businesses and health issues in countries where the target language is spoken
Cultural approach

Teaching Methods:

Development of all communication skills: written and oral expression and comprehension
Knowledge of the international professional and cultural environment
Mock job interviews, oral presentations with PowerPoint, mock meetings, writing letters and emails, debates, reading documents, etc.
Methodological aspects (based on the groups’ needs)
Exercises on a digital platform designed to review and reinforce language proficiency

Number of ECTS credits = 10 – TU Coordinator TU Béatrice BAÑULS

Essential prerequisite:
Have completed at least one internship during the Bachelor’s program
TU the first yearTU the Master’s program, both core and track-specific

Content and Objectives ofTU

2-hour class: preparation and guidelines for finding and completing an internship

3 to 5 months of full-time work experience at a public or private company.
Apply the knowledge acquired during the training program
Carry out a concrete professional project within the context of the company’s operations

Teaching Methods:

Written report, Oral exam, Evaluation by the internship supervisor

Number of ECTS credits = 5 – TU Coordinator TU   Patrice RAVEL

Essential prerequisite: This TU cannot TU separately from TU other TU to this program.

Course Details: 41 hours of lectures + 6 hours of tutorials This TU required hours (APP + hospital internship)

Objectives

• To provide students pursuing careers as Clinical Research Coordinators with the basic knowledge needed to set up and monitor clinical trials in accordance with good clinical practices.
• Define the different phases of clinical trials.
• To introduce the role of Clinical Research Associate (CRA) and all of its responsibilities.

Contents

Phase I, II, and III Clinical Trials

Clinical Trial Monitoring and Logistics

• Trial setup, protocol, observation log, e-CRF,
• Track monitoring visits from the first visit through the final visit.
• Investigators: Recruitment, Training, Brochures
• Essential documents for conducting tests (before, during, and after the test)
• Documents for submission to the HAS (ANSM, CPP, CNIL, etc.)
• Clinical Trial Allocation

Key Players and Roles in Clinical Research

• The Role of Arc Laboratory/Arc Hospital
• Organizations involved in clinical research (CIC, URC, CRC, CRB, etc.),

Bioequivalence Studies

• Testing of Medical Devices

Hospital Internship (4 weeks)

Speakers: External professionals

Number of ECTS credits = 5 – TU Coordinator TU  Patrice RAVEL

Essential prerequisite: This TU cannot TU separately from TU other TU to the program

Course Details:32 hours of lectures + 6 hours of lectures + 3 hours of tutorials

Objectives

• To provide students pursuing careers in clinical research and development with a basic understanding of the regulatory environment.
• Mastering Good Clinical Practices—ICH, CTD, FDA, EMEA, ANSM, CPP Standards…
• Learn the basics of pharmacovigilance and adverse drug reactions.
• Provide an overview of the basics of clinical trial planning.

Contents

• Regulatory Framework for Clinical Trials
• Good Clinical Practices – ICH, CTD, FDA, EMEA, ANSM, CPP, and other standards
• Quality Assurance and Quality Control in Clinical Research and Audits
• Pharmacovigilance, serious and non-serious adverse events
• Operational Planning

Teaching Methods:

• Lectures, tutorials, and projects supervised by professionals.

Assessment Methods:Written Exam – Case Study

Speakers: University of Montpellier and External Professionals

Number of ECTS credits = 5 – TU Coordinator TU    Patrice RAVEL

Essential prerequisites: 

This TU inseparable from the other TU to the program.

Prerequisites in Statistics: third-year Health Engineering program.

Objectives

• An Introduction to Clinical Database Management (Data Management)
• Know how to create a database from a CRF and understand the key data quality controls.
• An Introduction to Data Management and the Key Responsibilities of a Data Manager.
• Understand the various tools and methods for entering source data.
• Master the necessary fundamentals of statistical analysis as applied to clinical trials.

Contents

Data Management

• Definition and Responsibilities of a Data Manager
• Database structure, data quality control, database freeze

Introduction to SAS

• Creating tables, importing data files, and using simple procedures for the statistical analysis of clinical data.

Statistical Methodology Applied to Clinical Research

• Statistics Review
• Experimental designs: parallel designs, paired-series designs, crossover designs, bioequivalence tests

Epidemiological Studies

Medical Writing

Teaching Methods:

• Lectures, tutorials, lab sessions, and application of course material through a supervised project using ACCESS
• 5 three-hour hands-on sessions on SAS software per student

Assessment Criteria:

• Written Exam – SAS Practical Exam and Continuous Assessment
• Supervised Project and Written Report

Speakers

University of Montpellier: P. RAVEL, M. VIVIEN, R. SABATIER, and external professionals