MODM Clinical Database Management

ECTS credits = 5 –TU supervisorTU  Béatrice BAÑULS

Essential prerequisites:
Introduction to law desirable but not required
Essential principles of quality management

Marketing Understand the role of marketing and the analytical aspect (various market studies)

Financial analysis
Have a basic understanding of company accounts and the role of related items (balance sheet and income statement).

Content and Objectives ofTU 

Pharmaceutical Law(18 hours of lectures shared with the Master's in Medicines Science)
Legal Environment of Medicines (1 hour)
Health Products: Concepts and Regulations (1 hour)
Pharmaceutical Establishments (2 hours)
EEA MARKET AUTHORIZATION (specific medicines) (3 hours)
TU MARKET AUTHORIZATION TU CTD (3 hours)
Pharmacovigilance (2 hours)
Reimbursement prices (2 hours)
Advertising (2 hours)
Industrial property (2 hours)
Understanding the various texts applicable to the field of medicines, their origin, their legal value, and how they work together.
Understanding the concepts of different health products
Understanding the basics of the framework for the protection of innovation, manufacturing, marketing, and monitoring of medicines

Marketing: 9 a.m. CM
The overall marketing approach
Reminder on market research
Diagnostic tools and strategic initiation
Integrating the overall marketing approach
Understanding diagnostic tools and strategic orientations

Financial analysis: 6 hours of lectures + 3 hours of tutorials
Introduction to financial analysis
Principle of comparative analysis
Different ratios: Financial, economic, cash flow
Know how to analyze the profitability, solvency, and liquidity of an economic activity (industrial company).

Quality Management: 12 hours of lectures + 3 hours of tutorials (shared with the Master's in Pharmaceutical Sciences, except for course 3)
In the context of quality management in business, based on Good Practices and ISO standards:
1. Review of the basics of Quality Systems and business organization and documentation (3 hours)
2. Quality Control and Quality Assurance (2 hours)
3. Qualification and Validation: Control of equipment/software and implementation processes (2 x 1.5 hours for Master IS only)
4. Management of deviations and non-conformities (2 hours)
5. Continuous improvement: Corrective and preventive actions (2 hours)
3-hour tutorial: Non-conformity – CAPA

Safety: 6 hours CM
Introduction to ICPE
Corporate social responsibility: protecting workers and the environment
Safety Data Sheets and classification of hazardous substances and products: key elements of CSR

Teaching methods:
Marketing and Financial Analysis
Classes with student interaction through content and examples provided.
Specific questions on each of the topics covered.

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

Epidemiology:Health indicators, descriptive, etiological, and evaluative epidemiology
Health and the environment:Public health structures, national and regional environmental health management through public health plans, corporate social responsibility, description and behavior of different types of pollutants posing environmental and health risks, examples of contaminants that are problematic for health.
Databases:Relational model, simple SQL queries, table creation, constraint management, data import, form creation, report creation, macro creation, and use of VBA in ACCESS™.

Students must acquire the skills necessary to be able to
→Understandepidemiological studies:
Identify epidemiology as a public health tool
Understand epidemiological surveillance tools
Understand the different types of epidemiological surveys
Know how to interpret descriptive epidemiology indicators
Know how to calculate and interpret risk calculation results (RR and OR) from analytical epidemiology
Know how to describe and critique strategies, study protocols implemented in epidemiology
Be able to evaluate the validity of screening tests
→Understandthe behavior and impacts of pollutants on health and management tools in legislation (through examples)
Discover public health management in France,
Know how to recognize environmental health issues
→Discoverthe basics of database management
Understand how information is structured using the relational model
Recognize the different ways of using databases (Administrator/client)
Know how to build a database comprising several tables
Be able to define the main constraints on a database
Be able to use the main SQL language commands.
Be autonomous on the ACCESS data management system (Microsoft)

ECTS credits = 5 –TU supervisorTU  Xavier GARRIC

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

Content and Objectives ofTU 44 hours C

Health product development strategy and industrial environment: 29 hours of lectures:

• General knowledge of the pharmaceutical, cosmetics, and medical device sectors
• Knowledge of the regulatory and socio-economic specificities of the pharmaceutical, cosmetics, and medical device sectors
• Ethics in healthcare
• Functioning and culture of healthcare companies

Project management: 3 hours of lectures
• Introduction to project management for healthcare product development

Clinical development: 12 hours of lectures
• Introduction to conducting clinical trials in accordance with Good Clinical Practice (GCP)
• Drug development
• Clinical trial methodology
• The standard plan for a clinical trial protocol

Teaching methods:
Lectures focused on popularization with a focus 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 (Bachelor's degree level)

TU content and objectivesTU 22 hours of lectures + 6 hours of tutorials + 22 hours of practicals

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 biomedicines (2 hours), contemporary biotechnologies (3 hours). (10 hours)
Tutorial
• Recombinant DNA, virtual cloning (6 hours)

Practical work
•Practical work 1 => Cloning, production, purification, and characterization of a recombinant protein (12 hours)
• Practical work 2 => Establishment of a cell model for medium-throughput screening (10 hours)

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

Teaching methods:
The format of this TU, which focuses heavily on practical workshops and examples, should enable students to gain a fairly accurate picture of the use of biotechnology in healthcare and industry in general.

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

Essential prerequisite: High school diploma

 Content and Objectives ofTU
Modern Languages: 40 hours TD
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.

Communication: 9 a.m. Tutorial
Knowing how to work in a team and position oneself within a group.
Concept of group dynamics and team cohesion.
Communicating effectively, listening actively, and sharing ideas (techniques, methods, and networks).
Establishing constructive professional relationships (attitudes and postures); collaboration and consultation.
Negotiation techniques

Bibliography tutorial: 3 hours Tutorial
Knowing how to use the bibliographic resources of a university library
Knowing how to compile a relevant bibliography related to scientific subjects

Teaching methods:
Job interview simulations, oral presentations with PowerPoint, meeting simulations, letter and email writing, debates, document reading, etc.
Practical work on different skills (written and oral comprehension/expression)
TOEIC training
Methodological aspects (depending on the group's needs)
Exercises on a digital platform aimed at reviewing and consolidating language skills.

Communication: tests, exercises, role-playing

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

Essential prerequisite:Physiology program(Bachelor's degree), Knowledge of how a clinical trial is conducted

Terms and conditions:   43.5 hours of lectures + 6 hours of tutorials

Objectives

• Provide students pursuing careers in clinical research with basic knowledge of the various therapeutic areas that are the subject of clinical studies.
• Understanding the pharmacokinetic profile
• Knowing how to present yourself orally and in writing

CONTENTS ofTU

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 main variables involved in the conduct of phase 1 clinical development

PEC
Oral presentation by English and French students
Proofreading of CVs and cover letters

Teaching methods:
Lectures and tutorials

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

Essential prerequisite:
Have completed at least one internship during your bachelor'sTU
TU Master 1 core curriculum and specific to each course

Content and Objectives ofTU

2 hours CM: preparation and instructions for finding and completing an internship

3 to 5 months full-time in a public or private company.
Apply the knowledge acquired during the training program
Carry out a concrete professional project in the context of your activities

Teaching methods:

Written report, Oral exam, Assessment by the internship supervisor

Number of ECTS credits = 5 – 

TU ManagerTU  Caroline WEMYSS and Peter WEINMANN

Essential prerequisite: High schooldiploma

Content and Objectives ofTU  

Work on all communication skills: written and oral expression and comprehension
Knowledge of the international professional and cultural environment
Job interview simulation, oral presentation with PowerPoint, meeting simulation, letter and email writing, debates, document reading, etc.
Methodological aspects (according to group needs)
Exercises on a digital platform aimed at reviewing and consolidating language knowledge.
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:

Work on all communication skills: written and oral expression and comprehension
Knowledge of the international professional and cultural environment
Job interview simulations, oral presentations with PowerPoint, meeting simulations, letter and email writing, debates, document reading, etc.
Methodological aspects (according to group needs)
Exercises on a digital platform aimed at reviewing and consolidating language knowledge

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

Essential prerequisite:
Have completed at least one internship during your bachelor'sTU
TU Master 1 core curriculum and specific to each course

Content and Objectives ofTU

2 hours CM: preparation and instructions for finding and completing an internship

3 to 5 months full-time in a public or private company.
Apply the knowledge acquired during the training program
Carry out a concrete professional project in the context of your activities

Teaching methods:

Written report, Oral exam, Assessment 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 the program.

Terms and conditions: 41 hours of lectures + 6 hours of tutorials This TU reference hours (APP + hospital internship)

Objectives

• Provide students pursuing careers as Clinical Research Associates with the basic knowledge required to set up and monitor clinical trials in accordance with good clinical practices.
• Define the different phases of clinical trials.
• Present the role of Clinical Research Associate (CRA) and all of its responsibilities.

Content

Phase I, II, and III clinical trials

Clinical Trial Monitoring and Logistics

• Setup of the trial, protocol, observation log, e-CRF,
• Follow-up of monitoring visits from the first visit to the final visit.
• Investigators: recruitment, training, brochures
• Essential documents for conducting tests (before, during, and at the end of the test)
• Documents for submission to the HAS (ANSM, CPP, CNIL, etc.)
• Distribution of clinical batches

The players and professions involved in clinical research

• The profession of laboratory technician/hospital technician
• Structures involved in clinical research (CIC, URC, CRC, CRB, etc.),

Bioequivalence testing

• Testing for 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 separated from the other TU to the course.

Terms and conditions:32 hours of lectures + 6 hours of lectures + 3 hours of tutorials

Objectives

• Provide students pursuing careers in Clinical Research and Development with basic knowledge of the regulatory environment.
• Mastering Good Clinical Practices—ICH, CTD, FDA, EMEA, ANSM, CPP standardization, etc.
• Acquire the basics of pharmacovigilance and adverse effects.
• Provide the basics of clinical trial planning.

Content

• Regulatory environment for clinical trials
• Good Clinical Practices – ICH, CTD, FDA, EMEA, ANSM, CPP, etc. standardization
• Quality assurance and 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 supervisor TU    Patrice RAVEL

Essential prerequisite: 

This TU cannot TU separated from the other TU to the course.

Prerequisites in Statistics: Level L3 Health Engineering.

Objectives

• Getting started with clinical database management (Data Management)
• Know how to create a database from a CRF, understand the main controls related to data quality.
• Learn about data management and the main responsibilities of a data manager.
• Be familiar with the various tools for entering source data.
• Master the necessary basics of statistical analysis applied to clinical trials.

Content

Data Management

• Definition, the duties of the Data Manager
• Database structure, data quality control, base freeze

Introduction to the SAS language

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

Statistical methodology applied to clinical research

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

Epidemiological studies

Medical writing

Teaching methods:

• Lectures, tutorials, practicals, and implementation of lessons learned through a supervised project on ACCESS
• 5 three-hour practical sessions on SAS software per student

Assessment methods:

• 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