MODM coordination of clinical studies

Number ECTS = 5 - Responsible TU : Béatrice BAÑULS

Prerequisites:
Introduction to Law desirable but not required
The essential principles of Quality Management

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

Financial analysis
Know at least the company's accounts and the role of related items (balance sheet and income statement).

Content and objectives ofTU :

Pharmaceutical law(18h CM in common with Master Sciences du médicament)
Environnement Juridique du Médicament (1h)
Les Produits de Sante : Notions et Régimes (1h)
Etablissements Pharmaceutiques (2h)
AMM UNION EUROPEENNE (médicaments particuliers) (3H)
AMM HORS TU et CTD (3H)
Pharmacovigilance (2H)
Prix remboursement (2H)
Publicité (2H)
Propriété industrielle (2H)
Know the different texts applicable to the field of drugs, their origin, their legal value, their articulation.
Understandthe concepts of different health products
Understand the basic framework for protecting innovation, manufacturing, marketing and monitoring drugs.

Marketing: 9h CM
The global marketing approach
Reminder of market research
Diagnostic tools and strategic orientations
Integrate the global marketing approach
Know the diagnostic tools and strategic orientations

Financial analysis: 6h CM + 3h TD
Introduction to financial analysis
Principle of comparative analysis
The different ratios: financial, economic, cash flow
Know how to analyze the profitability, solvency and liquidity of an economic activity (industrial company).

Quality Management: 12 hCM + 3 h TD (in common with Master Sciences du médicament except course 3)
Within the framework of quality management in companies, based on Good Practices and ISO standards:
1. Reminder of the basics of Quality Systems and corporate organization and documentation (3h)
2. Quality Control and Quality Assurance (2h)
3. Qualification and Validation: Control of equipment/software and production processes (2 X 1.5h as for Master IS)
4. Management of deviations and non-conformities (2h)
5. Continuous improvement: Corrective and preventive actions (2h)
3h TD: Non-conformity - CAPA

Safety: 6 hrs 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
Lectures with student interaction through the content and examples provided.
Specific questioning on each part covered.

Number ECTS = 5 - Responsible TU : Hélène FENET -Aurélie ESCANDE - Patrice RAVEL

Epidemiology:Health indicators, descriptive, etiological and evaluative epidemiology
Health-Environment:Structuring of public health, national and regional management of environmental health through public health plans, corporate social responsibility, description and behavior of different types of pollutants at environmental and health risk, examples of problematic contaminants 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™.

The student must acquire the skills to be able to
→Apprehendepidemiological studies:
Identify epidemiology as a public health tool
Know the tools of epidemiological surveillance
Know the different types of epidemiological surveys
Know how to interpret descriptive epidemiology indicators
Know how to calculate and interpret the results of risk calculations (RR and OR) from analytical epidemiology
Know how to describe and criticize strategies, study protocols used in epidemiology
Be able to assess the validity of screening tests
→Knowthe behavior and impacts of pollutants on health and the management tools in legislation (through examples)
Discover public health management in France,
Recognize the stakes involved in environmental health
→Discoverthe basics of database management
Understand how Information is structured using the relational model
Recognize the different ways of using databases (Administrator/client)
Build a database with a few 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)

Number ECTS = 5 - Responsible TU : Xavier GARRIC

Prerequisites: General knowledge of biology, chemistry and galenic pharmacy

Content and objectives of theTU : 44H C

Healthcare product development strategy and industrial environment: 29h CM :

- General knowledge of the drug, cosmetics and medical devices sectors
- Knowledge of the regulatory and socio-economic specifics of the drug, cosmetics and medical devices sectors
- Ethics in healthcare
- Functioning and culture of healthcare companies
Project management: 3h CM
- Introduction to project management for the development of healthcare products
Clinical development : 12h CM
- Introduction to the conduct of clinical trials in compliance with Good Clinical Practice (GCP)
- Drug development
- Clinical trial methodology
- Standard clinical trial protocol
Teaching methods:
Lectures focusing on popularization, with an emphasis on exchanges with students
Tutored work using computerized project management tools

Number of ECTS = 5 - Responsible TU : Armelle CHOQUET & Arnault GRAINDORGE

Prerequisites: Knowledge of molecular and cellular biology (L3 level)

TU : 22h CM + 6h TD + 22h TP

CM
- Identification of molecular or cellular targets (Introduction=2h, -omics approaches=2h) and notions of biomarkers=2h (6h)
- Recombinant DNA technology=2h, CRISPR-Cas=2h, synthetic biology (2h): (6h)
- Industrial applications/examples: proteins, antibodies and vaccines (5h); optimization of biomedicines (2h), contemporary biotechnologies (3h). (10h)
TD
- Recombinant DNA, virtual cloning (6h)
TP
- TP1 => Cloning, production, purification, characterization of a recombinant protein (12h)
- TP2 => Establishment of a cell model for medium-throughput screening (10h)

Objectives:
Learn about the various health products derived from biotechnologies
Acquire notions of therapeutic targets and biomarkers
Acquire notions of medium- and high-throughput screening
Learn about recombinant DNA, molecular biology and synthetic biology technologies
Gain a practical insight into the conditions for producing a recombinant protein and developing a cellular model compatible with medium-throughput screening (practical work).

Teaching methods:
The format of this TU course, with its strong emphasis on practical workshops and examples, should enable students to acquire a fairly precise vision of the use of biotechnologies in healthcare and industry in general.

Number ECTS = 5 - Responsible TU : Gregory NICKSON and Béatrice BANULS

Prerequisite: BAC level

 TU Content and objectives:
Modern languages: 40h TD
Develop communication skills in a foreign language.
Specialized vocabulary.
Knowledge of companies and health issues in the target language countries.
Cultural approach.

Communication: 9h TD
Know how to work in a team and position yourself within a group.
Notion of group dynamics and team cohesion.
Communicate effectively, listen actively and share ideas (techniques, modes and networks).
Establish constructive professional relationships (attitudes and postures); collaboration and consultation.
Negotiation techniques

TD Bibliography: 3h TD
Use the bibliographic resources of a university library
Produce a relevant bibliography on scientific subjects

Teaching methods:
Job interview simulation, oral presentation with PowerPoint, meeting simulation, letter and e-mail writing, debates, reading documents etc....
Practical work on the different skills (written and oral comprehension/expression)
TOEIC practice
Methodological aspects (according to group needs)
Exercises on digital platform to review and consolidate knowledge of the language.

Communication: test, exercises, role-playing

Number of ECTS = 5 - Responsible TU : Patrice Ravel

Prerequisites: Physiology program (Bachelor's degree), knowledge of clinical trial procedures

Modalities: 43.5h CM + 6h TD

Objectives

• • Provide students intending to work in clinical research with a basic knowledge of the various therapeutic areas covered by clinical studies.
  • Understanding the pharmacokinetic file
  • Oral and written presentation skills

CONTENTS of theTU

THERAPEUTIC APPROACHES

Oncology, Cardiovascular, CNS, Pneumology, Thrombosis, Diabetes, Hypertension, Hematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectiology, Vaccine trials, Medical device trials

PHARMACOKINETICS

Definition of the main variables involved in Phase 1 clinical development

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

Teaching methods :
Lectures and tutorials

Assessment methods: Written test

Speakers

Montpellier University

BAÑULS Béatrice
KHIER Sonia
CROS Gérard
DRAKULOVSKI Pascal
C. Dupont
P. Licznar
V. Driss
Chevassus
V. Bellet

Outside professionals

• • M. Chettouh (CHU)

Number of ECTS = 5 - 

Responsible TU : Caroline WEMYSS and Peter WEINMANN

Prerequisite: BAC level

Content and objectives ofTU : 

Work on all communication skills: written and oral expression and comprehensionKnowledge of the international professional and cultural environmentSimulation of job interviews, oral presentations using PowerPoint, simulation of meetings, writing letters and e-mails, debates, reading documents, etc.Methodological aspects (depending on the needs of the groups)Exercises on digital platforms to review and consolidate knowledge of the language.Develop communication skills in a foreign language.Specialized vocabularyKnowledge of companies and health issues in the countries of the target languageCultural approach

Teaching methods :

Work on all communication skills: written and oral expression and comprehensionKnowledge of the international professional and cultural environmentSimulation of job interviews, oral presentations using PowerPoint, simulation of meetings, writing letters and e-mails, debates, reading documents, etc. Methodological aspects (according to group needs)Exercises on digital platforms to review and consolidate knowledge of the language.

Number ECTS = 10 - Responsible TU :Béatrice BAÑULS

Prerequisites:
Completion of at least one internship in the Bachelor's program
TU from the Master 1 core curriculum and specific to each pathway

Content and objectives ofTU :

2h CM: preparation and instructions for finding and carrying out an internship

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

Teaching methods :

Written report , Oral test, Internship supervisor's assessment

Number of ECTS = 5 - Responsible TU : Patrice RAVEL

Essential prerequisites: TU cannot be dissociated from the other TU courses.

Modalities : 41 h CM + 6 h TD This TU includes reference hours (APP + hospital internship)

Objectives

• Provide students intending to become Clinical Research Associates with the basic knowledge needed to set up and monitor clinical trials in line with good clinical practice.
• Define the different phases of clinical trials.
• Present the job of Clinical Research Associate (CRA) and all its missions.

Contents

Phase I, II, III clinical trials

Clinical trial monitoring and logistics

• Trial set-up, protocol, observation notebook, e-CRF,
• Follow-up of monitoring visits from the 1st visit to the closing visit.
• Investigators: recruitment, training, brochures
• Essential documents for conducting tests (before, during and at the end of the test)
• Documents for submission to HAS (ANSM, CPP, CNIL, etc.)
• Clinical batch distribution

The players and professions involved in clinical research

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

Bioequivalence tests

• Medical device testing

Hospital internship (4 weeks)

Speakers

Outside professionals

C. Leperchois
E. Edorh
E. Duluc
E. Belda
K. Mahadea
V. Roux

Number of ECTS = 5 - Responsible TU : Patrice RAVEL

Essential prerequisites: This TU cannot be dissociated from the other TU courses.

Modalities : 32 h CM + 6h CM +3h TD

Objectives

• To provide students intending to work in Clinical Research and Development with basic knowledge of the regulatory environment.
• Mastering Good Clinical Practice - standardization ICH, CTD, FDA, EMEA, ANSM, CPP ...
• Acquire the basics of pharmacovigilance and adverse reactions.
• Give the basics of clinical trial planning.

Contents

• Regulatory environment for clinical trials
• Good clinical practice - standardization ICH, CTD, FDA, EMEA, ANSM, CPP, ...
• Quality assurance and quality control in clinical research and auditing
• Pharmacovigilance, serious and non-serious adverse reactions
• Operational planning

Teaching methods :

• Lectures, tutorials and projects supervised by professionals.

Assessment methods :Written test - Case study

Speakers

University of Montpellier

BOISSERIE - LAPORTE Véronique
C. Audrey

Outside professionals

N. Bensmail
B. Buffin
O. Adotevi
G. Bellachem

Number of ECTS=5 - Responsible TU : Patrice RAVEL

Prerequisite: 

This TU cannot be dissociated from the other TU courses.

Statistics prerequisite: L3 Health Engineering level.

Objectives

• Introduction to clinical database management (Data Management)
• Know how to create a database from a CRF, and understand the main data quality controls.
• Learn about Data Management and the main tasks of a Data Manager.
• Know the different tools for entering source data.
• Master the basics of statistical analysis applied to clinical trials.

Contents

Data Management

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

Introduction to SAS language

• • Create tables, import data files, use simple procedures for statistical analysis of clinical data.

Statistical methodology applied to clinical research

• • Statistics reminder
  • Experimental designs: parallel designs, matched series designs, cross-over designs, bioequivalence tests

Epidemiological studies

Medical writing

Teaching methods :

• CM, TD, TP, and implementation of lessons through a tutored project on ACCESS
• 5 sessions of 3 hours of practical work on SAS software per student

Assessment methods :

• Written test - SAS practical test and continuous assessment
• Tutored project and written report

Speakers

University of Montpellier

• • P. RAVEL
  • M. VIVIEN
  • R. SABATIER

Outside professionals

• • W. AGOUMI
  • T. VANDENBOSSCHE

Number ECTS = 5 - Responsible TU :Philippe CREMADES - Béatrice BAÑULS

Essential prerequisites:
An initial knowledge (even minimal) of a company's financial items (balance sheet, income statement, etc.).

Content and objectives ofTU :

Project management:
the environment (organizations, stakeholders, etc.), the project life cycle and the ten knowledge areas of the Project Management Body of Knowledge (PMI®).
Operational planning: project analysis methods, Ford algorithm, milord algorithm; exercises and case studies.

Management control and performance management
Analysis of intermediate operating totals
Ration of profitability, profitability and performance
Practical applications

Work on a project management software package

TU objectives:

Project management: understanding the concepts, processes and methods of project management within the framework described by the Project Management Institute®. Operational planning: from project analysis to establishing a feasible workload plan.

Management control: evaluate and understand profitability and performance items through a company income statement.

Teaching methods :

Lectures and tutorials, Thematic lectures in amphitheatre, Application and comprehension exercises in tutorials

Number of ECTS = 5 - Responsible TU : Emmanuel ROBIN-Béatrice BAÑULS

Essential prerequisites:
Marketing: Initial knowledge of the global marketing approach
Quality: Initial knowledge of how a quality management system works.

Content and objectives ofTU :

Team management :20 H TD
Objectives:
Clarify the missions, roles and functions of a team manager (project).
Understand the influence of your leadership on team performance.
Identify your management style and negotiation style.
Know how to lead meetings.
Self-knowledge. Personal characteristics impacting relationships with others.

Contents
Building a team, the conditions for its effectiveness. Managing the transition between a group and a team
The different roles within a team
Definition of team management. The key actions of a manager or project leader.
Reflecting on different management styles (self-diagnosis, role-playing)
Meeting facilitation training. Facilitator's functions. Facilitation techniques.
Negotiation and conflict management (self-diagnosis, simulations)

Quality management :12h CM + 6h TD
Within the framework of quality management in companies, based on Good Practices and ISO standards:
- Review of organizational elements, principles and tools for quality management and continuous improvement
- Product and project development: from requirements to design
- Risk management: general principles and risk assessment tools
- Change management of products, processes and methods, processes, studies

Marketing: 12h CM
Understand market mechanisms.
Identify the players involved and analyze the influencing factors.
Know the different strategic maneuvers (with regard to demand and the competition).
Define the appropriate operational methods.
Integrate digital marketing methods.

Number of ECTS = 2.5 - Manager TU : Myrtille VIVIEN

Prerequisites: General knowledge of clinical research.

Objectives :

• Learn the basics of CDISC and SDTM standards
• Know the regulations concerning patient data
• How to draw up a validation plan for a clinical study
• Know how to carry out data cleaning steps
• Understanding the basics of risk management
• Know and understand the issues involved in coding adverse events and concomitant treatments, and the different coding dictionaries.
• Understanding the different data sources involved in clinical trials

Contents ofTU :

• CDISC - SDTM
• Data validation
• Risk management
• Coding adverse events and concomitant treatments
• RGPD
• Real-life data
• Connected devices
• Clinical project management
• Databank

Teaching methods :

Lectures given by professionals in the various fields covered.

Assessment methods :

Written test

Number of ECTS = 5 - Responsible TU : Abdeslam EL GHZAOUI

Objectives

• Understand, through examples of real industrial projects, the concepts of project management linked to the control and management of deadlines, resources, risks and budgets.

Contents

• Why and how?
• Location and type of company projects.
• Organizing projects - design approaches.
• Resource and risk management.
• Controlling deadlines and costs.
• Project planning.
• Critical path.
• Breaking down projects into tasks.
• Drawing up a provisional budget.
• Business plan.

Teaching methods.

• Lectures and tutorials.

Assessment procedures.

• Written test

Number of ECTS = 5 - Manager TU :Patrice Ravel

Essential prerequisites: TU Clinical Operations Management is aimed at students with a CRA background (Master 1 MODM) or employees with CRA experience.

Objectives

• Coordinate and supervise the conduct of international clinical studies in compliance with regulations and deadlines.
• Define human and financial resource requirements for clinical development projects
• Leading and coordinating international monitoring teams in compliance with regulations and deadlines

Contents

• Setting up the clinical study in compliance with regulations and deadlines

• Project management plan, monitoring plan, SAE flow plan....
• Feasibility study, organization and participation in Investigator meetings, preparation of monitoring and closing visits, etc.
• Preparation of files for submission to the competent authorities
• Clinical study budgeting, Subcontracting management
• Medical writing
• Risk management in clinical trials
• LeanManagement

Contents

• Setting up the clinical study in compliance with regulations and deadlines

• Project management plan, monitoring plan, SAE flow plan....
• Feasibility study, organization and participation in Investigator meetings, preparation of monitoring and closing visits, etc.
• Preparation of files for submission to the competent authorities
• Clinical study budgeting, Subcontracting management
• Medical writing
• Risk management in clinical trials
• Lean Management

Teaching methods :

• CM, lectures, and implementation of lessons through tutored professional projects

Assessment methods :

• Written test - Case study

Number of ECTS = 5 -Responsible TU : Patrice RAVEL

Essential prerequisites: TU Clinical Operations Management is aimed at students with a CRA background (Master 1 MODM) or employees with CRA experience.

Objectives

• Coordinate and supervise the conduct of international clinical studies in compliance with regulations and deadlines.
• Marketing and post-marketing in clinical trials
• Pharmacovigilance management
• Supply chain management

Contents

• International regulations
• Essential documents (ICH 6)
• Management of submission files for HAS documents (ICH 8)
• Quality assurance, auditing
• Marketing Research
• Post-marketing studies
• Pharmacovigilance - SAE Data Reconciliation
• Generics - bioequivalence
• IP circuit, Clinical Supply Chain
• Pharmacoeconomics -
• Remote testing and ICTE
• Ethics in clinical trials

Teaching methods :

• CM, lectures, and implementation of lessons through tutored professional projects

Assessment methods :

• Test - Case study (App)

Number of ECTS = 2.5 - Responsible TU : Patrice RAVEL

Modalities :25 h TD

Prerequisites: TU core curriculum + TU specific to the first semester of Master 2

Objectives

• Practical application of Master 2 course content through case studies supervised by pharmaceutical industry professionals

Contents

• Submission of an international clinical study to HAS
• Contract and budget management for a CRO
• Clinical batch management
• CE certification

Teaching methods :

• Work in groups of 4 to 6 students, depending on the projects proposed.
• At the end of the lesson, the professional poses the problem to be tackled by the group of students.
•  Within each group, students divide up the work to be done.
•  Projects are monitored on a regular basis according to a pre-established schedule.

Assessment methods :

• Written report - Oral test

Number of ECTS = 20 - Responsible TU :Béatrice BAÑULS

Prerequisites:
Completion of a Master 1 with an internship and/or work experience
Completion of the core Master 2 courses and the specific courses for each pathway

Content and objectives ofTU :

2h CM: preparation and instructions for finding and carrying out an internship
4 to 6 months full-time in a public or private company.
Apply the knowledge acquired during the course
Carry out a concrete professional project in the context of its activities.

Teaching methods :

Written report, Oral test, Assessment by training supervisor

Number of ECTS = 2.5 - Responsible TU : Patrice RAVEL

Modalities : 20h CM, 5h TD

Essential prerequisites: TU Clinical Operations Management is aimed at students with a CRA background (Master 1 MODM) or employees with CRA experience.

Objectives

• Understanding and interpreting a statistical analysis plan in clinical trials, (ICH)
• Introduction to VBA spreadsheet programming

Contents

Statistical analysis (ICH E9)

• The main plans (parallel group, cross over, etc.)
• Primary and secondary variables
• Number of subjects required
• The main comparative statistical tests in clinical trials
• Population types (ITT, PP)
• Statistical Analysis Plan (SAP)

The VBA language

• Notion of algorithm
• Macros
• The main VBA instructions: variables, typing, conditional structures, loop structures, procedures and functions
• Examples of dashboards specific to clinical research

Teaching methods :

• TheTU Clinical Operations Management program is aimed at students with a CRA background (Master 1 MODM) or employees with experience in the CRA profession.

Assessment methods :

• Written test - Case study (APP)

Number of ECTS = 2.5 - Responsible TU :Patrice RAVEL

Modalities: 25h CM

Prerequisites: TU core curriculum + TU specific to the second semester of Master 2

Objectives

• Learn about specific clinical trials and their particular features.

Contents

• Vaccine clinical trials
• Clinical trials and medical devices
• Clinical trials and rare diseases
• Diagnostic clinical trials
• Pediatric investigation plan
• Quality of life in clinical trials

Assessment methods :

•  Written test - Case study

Number of ECTS = 5 - Responsible TU :Patrice RAVEL

Prerequisites: TU core curriculum + TU specific to the first semester of Master 2

Objectives

• Case studies supervised by clinical research professionals to put into practice the teaching content of the Master 2 course.

Contents

• Clinical Operations Management

Teaching methods :

• Individual or small group work
•  Projects are monitored on a regular basis according to a pre-established schedule.

Assessment methods :

• Written report - Oral test