DMCC

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.
Understand the 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 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 => Establishing 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, document reading 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.

(32H CM, 3H CM/TD, 15H TP) (5 ECTS)

Review of general polymer concepts

• Mechanical and viscoelastic properties of polymers
• Analysis and characterization techniques for medical devices
• Hydrogels and bio-adhesion
• Integrated practical work

Responsible TU : Caroline WEMYSS and Peter WEINMANN

Prerequisite: BAC level

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 e-mail writing, debates, document reading, etc.
Methodological aspects (according to group needs)
Exercises on digital platform to review and consolidate knowledge of the language.
Develop communication skills in a foreign language.
Specialized vocabulary
Knowledge of business and health issues in the target language countries
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 simulation, oral presentation with PowerPoint, meeting simulation, letter and e-mail writing, debates, document reading, etc.
Methodological aspects (according to group needs)
Exercises on digital platform 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

(23H CM, 3H TD, 24H TP) (5 ECTS)

• Healthcare polymers
• Plastic formulation/shaping
• 3D printing advanced course
• Polymers for scaffolds and implants
• Polymer degradation and ageing
• Surface and chemical modifications of polymers
• Polymers for parenteral applications
• Vectorization
• Integrated practical work
• Trade shows and company visits

(35H CM, 3H TD, 12 H TP) (5 ECTS)

• Biomaterials classification and fields of application
• Biocompatibility, biostability, biofunctionality and specifications
• DM design process
• Innovation and feasibility study
• Regulatory and economic approaches to medical devices
• Prolonged, modulated and sequential release of active ingredients
• Medical devices and biomacromolecules: manufacturing and applications
• Integrated practical work

(6H CM, 5H CMTD, 6 H TP and 33 H innovation pédagogique)

The objective of this TU is, starting from a valuable idea in the field of medical devices,
to define a medical device design strategy and set up a
practical feasibility study, integrating economic and regulatory constraints.
Students work in groups of 3 to detail the different stages in the design of a
device. They are expected to make cross-disciplinary use of the new knowledge they have acquired through
courses in medical device shaping and characterization.

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 (project) manager.
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 competition).
Define the appropriate operational methods.
Integrate digital marketing methods.

shadow of ECTS = 5 - Responsible TU : Xavier GARRIC

Prerequisites:General knowledge of biology and chemistry

Contentsof theTU :30H CM, 12H CMTD, 9 H TD

Contents

• Review of medical devices and biomaterials: (4 HCM + 3H TD) (Xavier Garric)
• Innovation in medical devices 12H CM TD (Xavier Garric) Interactive teaching in the Learning Lab
• Patents and Intellectual Property (Dr Elodie Verhaeghe) (3H CM + 3 H TD)
• Classification of medical devices by specialty (approx. 30 H) :
  • Cardiovascular surgery 2H (Pr Ludovic Canaud)
  • Neurosurgery 2H (Pr Nicolas Lonjon )
  • Orthopedic and trauma surgery 2H(Pr Chammas)
  • Visceral surgery 3H (Dr Edouard Girard)
  • Urology 2H (Pr Rodolphe Thuret)
  • ENT and cochlear implants 2H (Dr Favier)
  • Wounds and healing (2H) (Dr Christine Faure-Chazelle)
  • Endocrinology 2H (Pr Eric Renard)
  • Invitro diagnostic DM: biomarkers 6H CM + 3H TD (Pr Christophe Hirtz)

Objectives

• An introduction to the medical device sector
• Know the anatomical, histological, regulatory and medico-economic specificities of the various medical disciplines that use medical devices
• Identify major classes of medical devices by specialty
• Understanding innovation paths in different specialties

Teaching methods :

Lectures, tutorials, interactive courses in the Learning Lab

Assessment methods: Written test - Continuous assessment

Number of ECTS = 5 - Responsible TU : Xavier GARRIC

Prerequisites: General knowledge of medical devices

Content: 31 H CM and 10H TD

• The global regulatory landscape for medical devices (Sabrina Feddag-3H CM)
• The New European Regulation (Christine Quinton) (3H CM)
• U.S. FDA regulations (Patricia Forest) (4H CM)
• Chinese regulations-NMPA (3H CM) not 'intervenant
• DM standards and software (Clémentine Liard) (3H CM)
• DMs and artificial intelligence (Guillaume Promé) (3H CM)
• Regulation of IVDDs (Delphine Audureau Biomérieux) 3HCM)
• Regulatory watch and research (Guillaume Promé) (3H TD)
• Standardization in healthcare (Pierre-Yves Joyeux) (3H CM)
• Marketing and advertising regulations (Dr Virginie Rage-Andrieu) (6H CM)
• Health risk management for medical devices - Standards: ISO 13 485 - GMP - EuGMP (Dr Virginie Griotto) (3HCM)
• Tutorial (Christian Pompée 3H TD and Xavier Garric 4HTD)

Objectives

• Provide students with general regulatory information on medical devices
• Provide general and regulatory knowledge of the pre-marketing stages in terms of medico-economic evaluation and market access.

Teaching methodsLectures, tutorials and mini-projects based on real-life company situations

Number of ECTS = 5 - Responsible TU : Xavier GARRIC

Prerequisites: General knowledge of biology and chemistry

Course contentTU :30 H CM 10H TD

• Medico-economic evaluation of medical devices (Dr Géraldine Leguelinel 3H)
• DM in the hospital: referencing, contract of good use, why and how a DM enters the hospital (Dr Jérome Perrey) (3H CM + 3H TD)
• CNEDiMTS (Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé) (Aurelie Pacull-HAS, 3HTD):
• Benefit/risk ratio of medical devices (Guillaume Promé) (3HCM)
• Specifications and evaluation of medical devices (Xavier Garric ) (7H TD)
• Biocompatibility of medical devices: Ms Sonia El Hadj (6H, NAMSA)
• Microbiology and sterilization of medical devices: Mr Frédéric Cadoret (6H, NAMSA)
• Clinical investigation of DM (Dr Audrey Castet)(3H CM)
• Clinical evaluation and material-epidemiology(Dr Thierry Chevallier) (3H CM)
• Regulatory context for clinical evaluations (Elsa Oliveira) (3H,CM, Nexialist)

Objectives

• Know how to search and read a patent.
• Understand the full range of intellectual property rights and strategies: not just filing for rights, but also valuation, exploitation and defense (e.g. in the event of counterfeiting), as well as prior art searches, legal advice, training and financial evaluation.
• Knowledge of the different stages and associated constraints of preclinical evaluation
• Theoretical and practical knowledge of the conduct of a medical device clinical trial
• Knowledge of the regulatory and administrative aspects of clinical and pre-clinical trials

Teaching methods : Lectures - Tutorials

Assessment methods: Written test - Continuous assessment

Number of ECTS = 5 = Responsible TU : Xavier GARRIC

Prerequisites: General knowledge of medical devices

Content andTU :30 H CM / 10 h TD

• Creating a start-up: the example of Womed (Xavier Garric 3H CM + 1H TD)
• The different stages in the DM life cycle (Christian Pompée-) (27 H CM 4H TD
  1- Design and development (Towards CE marking)
  - Clinical needs and competing products
  - Product specification, design input data (Standards 14630)
  - Fitness for use and link with risk management
  - Design transfer and industrialization
  - Process validation : (Assembly, Packaging, Sterilization...
  - Biocompatibility
  - Pre-clinical and clinical studies
  - Verification and validation of the design and marketing
  - Constitution of the technical file
  - Operation of the company and suppliers
  2- Post-CE Marking
  - Clinical monitoring (listening to customers, material vigilance, clinical follow-ups, etc.)
  - Process control following the validation master plan
  - Process approach (indicators) and change management
  - Commercial environment (Sales representatives, distributors, sales agents) responsibilities (training, stock management and traceability)
• Company visit (production site) 3H

Objectives

• Present the company's various activities
• Explain the medical device life cycle within the company
• Describe the various stages in the company's life cycle
• Understand how companies adapt to regulatory texts to design, produce and market medical devices.

Teaching methods: Lectures

Number of ECST = 5 - Manager TU : Xavier GARRIC

Prerequisites: General knowledge of medical devices

Course contentTU :30 h CM / 10h TD

• Marketing applied to DM (Laetitia Kauzner_Innopsys) (3 H CM + 3 H TD) :
  • Marketing strategy and regulatory constraints
  • Distribution
  • Advertising and communications

• Industry presentations: What does your job involve, what is your role in the company? (15 H CM)
  • The job of DM product manager (Aurélien Simonini- Pierre Fabre Oral Care) (3H CM)
  • Risk management (Cécile Comte) (3H)
  • Supply chain, manufacturing management and supply planning (Gabin Monsan) (3H CM)
  • Metrology-Quality Control (Damien Stéfanelli) (3H CM)
  • Setting up a clinical study (Pauline Chirouze) (3H CM)
  • Developing a software DM in a start-up (Yoann Dutil) (3H CM)
  • Business Development (Gonzague Issenmann) (3H CM)
  • Application engineer Chartlotte Quemerch (Balt 3H CM)
• 6H Alumni Day

Objectives :

Know how to manage and control the production and marketing of medical devices

Understand the real roles in a medical device company

Teaching methods: Lectures - Tutorials

Assessment methods: Written test - Continuous assessment

mber of ECTS = 5 - Responsible TU : Xavier GARRIC

Prerequisites: General knowledge of medical devices

Content andTU : 8HTD + 42 H TD Pedagogical innovation

• Students work in groups of 4-5 to detail the different phases leading up to the marketing of a DM (Research, Development, Production, Marketing, Post-Marketing). They will have to make cross-disciplinary use of the new knowledge they have acquired during their lessons on quality, regulations, risk management and project management.
• Projects are supervised by research professors and industrialists with expertise in biomaterials and medical devices.
• The proposed topics are designed to respond to a clinical problem for which there are currently no therapeutic solutions. Topics may be proposed by companies in the field.

Objectives :

- Develop the autonomy and initiative of students with a view to marketing a medical device
- Identify a medical need and analyze a market
- Draw up specifications adapted to the application
- Understand the various stages in the life cycle of a medical device required to market an innovative medical device in compliance with the quality approach. of the DM life cycle required to market an innovative medical device in compliance with the quality approach
- Set up a marketing plan
- Define the structure of a CE marking technical file in compliance with MDR 2017 and a quality management system in compliance with standard 13485

Teaching methodsThis project-based learning takes the form of tutorials and time for exchanges between small groups and supervisors.

Assessment methods: Oral presentation - Written report /25

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