CPPS medicine

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

Prerequisites essential. Knowledge of biophysics, rheology, physicochemistry of interfaces and thermodynamics is required.

Objectives

• Enable students to understand and master the physical and physicochemical concepts required for the design, development, formulation and manufacture of pharmaceutical, cosmetic and food products.

Content

• Polymorphism
• Chemical and physical degradation of active ingredients
• Thermodynamics of mixtures
• Defining, measuring and predicting the solubility of active ingredients
• Solubilization strategy for active ingredients
• Physical stabilization of multiphase systems
• D.L.V.O. theory
• Rheology of complex materials

Teaching methods.

• Lectures, learning lab and tutorials

Assessment methods:Written test

Number of ECTS = 2 -Responsible TU :Sylvie BEGU

Prerequisite:TU PAM1PHYF Physicochemistry of health product formulation (Resp A. El Ghzaoui)

Objectives

• Knowledge of skin physiology/mechanisms and of the main galenics developed for the topical route.

Contents of the TU :

• Raw materials and topical formulations (8h CM) (S. Begu)
• Washing agents and foaming agents (3h CM) (S. Begu)
• Skin: physiology, penetration route, penetration promoter, penetration assessment 3h CM (S. Begu)
• Curating and packaging 3h CM (A. Aubert)
• Seminar: Pierre Fabre (MPs regulation), Seppic, Gattefossé

Teaching methods:

• CM, CM/TD, TD, industrial seminar

Assessment methods :

• Written test /20 (CM, CM/TD, TD, seminar) - Duration 1 hour

Number of ECTS = 2 -Responsible TU :SOULAIROL Ian

Essential prerequisites:

• TU Pharmacie Galénique et Formulation - L3 Ingénierie de la Santé de Montpellier or equivalent
• TU Surface phenomena - L3 Ingénierie de la Santé de Montpellier or equivalent

Objectives

• To train students in the knowledge of excipients for pharmaceutical use and their functionalities for the formulation and preparation of various products.
• galenic forms for the most essential routes of administration.

Contents of the TU :

• Raw materials and formulation of oral dry dosage forms - 8h. CM - DELALONDE Michèle
• Flavoring, sweetening and coloring of drugs - CM 2h. -SOULAIROL Ian
• Functionalization of pharmaceutical excipients - CM 2h. and TD 2h. - SHARKAWI Tahmer
• Raw materials and formulation of parenteral pharmaceutical forms - CM 4h. and TD 2h. - NOTTELET Benjamin
• Materials and types of packaging for drugs - CM 3h. - SOULAIROL Ian
• Analytical methods for characterizing pharmaceutical raw materials - CM 4,5h. and TD 2,5h. - SANCHEZ-BALLESTER Noelia
• Professional seminars: 2 x 3 h.

Teaching methods:

• Face-to-face teaching: lectures, tutorials, tutorials.

Assessment methods: Written test

Number of ECTS = 5 -Responsible TU :SOULAIROL Ian

Essential prerequisites:

• TU Pharmacie Galénique et Formulation - L3 Ingénierie de la Santé de Montpellier or equivalent TU
• TU Surface phenomena - L3 Ingénierie de la Santé de Montpellier or equivalent TU

Objectives

• Train students in various industrial pharmaceutical operations and industrial pharmacotechnics.
• Introduce students to operational quality assurance and international pharmaceutical production regulations.

Contents of the TU :

• Quality assurance and Good Manufacturing Practices (GMP, GMP, cGMP) - ICH - ISO - 3h. CM - BATAILLE Bernard
• European Pharmacopoeia and American Pharmacopoeia: content, constraints and regulatory obligations - 2h. CM BATAILLE Bernard
• Pharmaceutical powders - Compression - Coating and laminating - 15h. CM - DELALONDE Michèle
• Mixing, drying, atomization, freeze-drying, granulation - 12h. - CM - SHARKAWI Tahmer
• Sterilization and grinding operation - 6h. CM - SOULAIROL Ian
• Microencapsulation operations - 6h. CM - VACHOUD Laurent
• Design of experiments in pharmaceutical production - 6h. TD - RAVEL Patrice

Teaching methods:

• Classroom teaching: Lectures and tutorials

Assessment methods: Written test - Continuous assessment - Experimental design

Number of ECTS = 5 -Responsible TU :SOULAIROL Ian

Essential prerequisites:

• TU Pharmacie Galénique et Formulation - L3 Ingénierie de la Santé de Montpellier or equivalent
• TU Surface phenomena - L3 Ingénierie de la Santé de Montpellier or equivalent
• TU Polymers of therapeutic interest - L3 Ingénierie de la Santé de Montpellier or equivalent
• TU Statistical analysis of pharmaceutical data - L3 Ingénierie de la Santé de Montpellier or equivalent

Objectives

• Train students to manage and carry out a drug development project.
• Train students to write technical reports and present experimental results.
• Train students in project management.

Contents of the TU :

• Group and individual work: formulation design, laboratory-scale preparation, quality control and packaging (primary and secondary) of a drug.
• Individual training in writing and presenting technical reports.

Teaching methods:

• - Practical and tutorial work by groups of students supervised by a teacher-researcher.
• - Learning Lab.

Assessment methods: Report and Gold

Number of ECTS = 5 - Manager TU : SOULAIROL Ian

Essential prerequisites:

• TU Pharmacie Galénique et Formulation - L3 Ingénierie de la Santé Montpellier or any other equivalent
• TU specific to Montpellier's Master 1 in Health Engineering or equivalent
• 5th year Pharmacy validated

Objectives

• Specialize students in drug formulation, industrial process implementation and production control of galenic forms.
• Develop teamwork and autonomy.
• Be able to monitor technological developments

Contents of the TU :

• Formulation and industrial processes applied to dry oral forms - CM/TD 6h. - DELALONDE Michèle
• Formulation and industrial processes applied to parenteral forms - CM/TD 6 h. - SHARKAWI Tahmer
• Formulation and industrial processes applied to skin forms - CM/TD 6 h. - SOULAIROL Ian
• Granulation, compression and lamination processes - TD- 9 h. - AUBERT Adrien
• Methods for characterizing raw materials and finished products - CM/TD 3 h. - SANCHEZ-BALLESTER Noelia

Teaching methods:

• Teaching supervised by a teacher-researcher and in autonomy (flipped course method)
• Independent work (student groups)
• CM/TD
• TD
• Learning lab

Assessment methods: Written and oral test

Number of ECTS = 5 -Responsible TU :SOULAIROL Ian

Essential prerequisites :

• The TU of the Master 1 Ingénierie de la Santé de Montpellier - Conception et Production des Produits de Santé Spécialité Médicament or any other equivalent training (validated 5th year Pharmacy, other Master, ....
•  Knowledge of project management.

Objectives

• Train students to implement the pharmaceutical company's operational quality policy: drawing up, applying and complying with procedures, organizing quality audits on production sites, setting up and monitoring operational quality indicators.
• Management of all these activities.

Contents of the TU :

• Quality management in pharmaceutical production - CM 12 h. - RAFFALLI Emma
• Validations of computerized systems - CM/TD 4 h. - BOUDIAF Youcef
• Amelioration continue - Lean Manufacturing - CM 4h. - BATAILLE Bernard
• Product Quality Review - CM 3h. - BATAILLE Bernard
• Risk management applied to pharmaceutical production - CM 6 h. - BATAILLE Bernard
• GMP-compliant documentation (procedures, operating methods, instructions, ....) - CM 2 h. - BATAILLE Bernard
• Statistical Process Control (SPC) - TD 12 h. - RAVEL Patrice
• Pharma 4.0 and digitalization of the pharmaceutical plant - CM/TD 4h. - BOUDIAF Youcef
• Professional seminars and industrial site visit: TD 15 h.

Teaching methods:

• Face-to-face teaching :

- Lectures (27 h.)
- Lectures / Tutorials (8 h.)
- Tutorials (12 h.)

Assessment methods:
Written test with : One test for Enseignements B Bataille - E RAFFALLI - Y BOUDIAF and one test for Enseignements P. RAVEL

Number of ECST = 5 -Responsible TU :SOULAIROL Ian

Essential prerequisites:

• The TU of the Master 1 Ingénierie de la Santé de Montpellier - Conception et Production des Produits de Santé Spécialité Médicament or any other equivalent training (validated 5th year Pharmacy, other Master, ....).
• Knowledge of drug regulation (GMP, GMP, cGMP)

Objectives

• Prepare managers to take on responsibilities in R&D, Process/Transposition and Pharmaceutical Production, and to apply and enforce the relevant aspects of international pharmaceutical regulations.

Contents of the TU :

• Annex 15 (European GMP) - Qualification/Validation (cGMP USA) - CM 3h. BATAILLE Bernard
• Scale transposition - CM 3h. - BATAILLE Bernard
• Dimensional analysis and scale transfer - CM 15h. - EL GHZAOUI Abdeslam
• Production transfer - CM 3h. - BATAILLE Bernard
• Continuous manufacturing processes and P.A.T. - CM 3h. - BATAILLE Bernar
• Change control and change management - CM/TD - 6h. - GIDOIN Pascal
• Cleaning validation in the pharmaceutical industry - CM/TD 6h. - REUMAUX Eric
• Preparing for an ANSM inspection in production - CM - 4 h. - BOUDIAF Youcef
• Drug packaging: innovations and the fight against counterfeiting CM - 4 h. - BOUDIAF Youce
•  Air and environmental control in the pharmaceutical industry - CM/TD 2h. -SOULAIROL Ian
• Professional seminars: TD 12 h.

Teaching methods:

• Face-to-face teaching: - Lectures: 35 h - Lectures / Tutorials: 14 h - Learning lab (simulation exercises)

Assessment methods: Written test

Number of ECTS = 5 - Manager TU : SOULAIROL Ian

Essential prerequisites:

• TU of the Master 1 Ingénierie de la Santé de Montpellier or any other equivalent Master's course content.
• Validated 5th year pharmacy curriculum

Objectives

• Synthesis, critical analysis and presentation of pharmaceutical regulatory documents.
• Presentation of results in the form of a Power Point presentation (or equivalent) to the class of students, with a question-and-answer session.

Contents of the TU :

• Synthesis, critical analysis and feedback on the ICH "Quality" Guidelines - Specific analysis of guidelines Q8, Q9 and Q10
  - Student-led tutorials (42 h.)
  - Tutorial : Presentation of topics (2 h.) mid-course framing (2 h.), feedback and correction by a teacher-researcher (4 h.)

Teaching methods:

• Tutorial : Group and individual work after presentation by a teacher-researcher in a learning lab.
• Reverse teaching method
• Restitution and correction by a teacher-researcher

Assessment methods: Report (Power Point presentation or equivalent) - Oral (group and individual presentation) - Continuous assessment (group and individual).

Number of ECTS = 3 -Responsible TU :SOULAIROL Ian

Essential prerequisites

• TU the core syllabus of the Master 2 in Health Engineering from Montpellier or any other equivalent qualification
• Statistical methods of analysis in pharmacy

Objectives

• Introduce and train students in the systems and management of production and the supply chain in a pharmaceutical company.
• Know how to plan and manage logistics operations in compliance with quality and cost requirements, in line with the company's overall objectives.
• Know and apply inventory and flow management methods.

Contents of the TU :

• - Production systems - Production management - Inventory management - MRP - Financial approach to production management - CM (18 h.) and TD 12 h. - RAFFALLI Emma
• - Professional seminar - TD 3h.Teaching methods :
• - Lectures / Tutorials
• - Tutorial

Assessment methods: Written test - Continuous assessment

Number of ECTS = 2 -Responsible TU :SOULAIROL Ian

Essential prerequisites:

• TU the core syllabus of the Master 2 in Health Engineering from Montpellier or any other equivalent qualification
• Statistical methods of analysis in pharmacy

Objectives

• Introduce and train students in Supply Chain Management in pharmaceutical production. Provide future managers with the tools they need to accurately estimate needs, availability and capacity, in order to better synchronize the elements of the global supply and manufacturing chain.

Contents of the TU :

• Introduction to the supply chain - CM/TD 6 h. - SAINT-MARTIN Emmanuel
• Introduction to Supply Chain Management - CM/TD 6 h. - SAINT-MARTIN Emmanuel
• Serious game" case study. CM/TD 6 h. - SAINT-MARTIN Emmanuel

Teaching methods:

• Lectures / Tutorials
• Tutorial using a Serious Game

Assessment methods: Written test

Number of ECTS = 5 -Responsible TU :SOULAIROL Ian

 ESSENTIAL PREREQUISITE:

• The TU of the Master 1 Ingénierie de la Santé de Montpellier - Conception et Production des Produits de Santé Spécialité Médicament or any other equivalent training (validated ^5thyear Pharmacy, other Master, ....).
• Knowledge of project management and project execution

GOALS

Conducting and managing a practical case study related to the course specialty

• Students in initial training :
• Design, conduct and manage a practical case study to qualify laboratory equipment and validate a process on said equipment.
• Write up and present experimental results.
• Independent group and individual work, supervised by a teacher-researcher.
• Students on work-study programs (apprenticeships) :
• Conduct and execute learning assignment(s)
• Write up and present experimental results
• Work independently and in the company under the guidance and supervision of the apprenticeship supervisor.

Contents of theTU 

• Students in initial training:
  - Equipment qualification / process validation - Group and individual work under the supervision of a teacher-researcher.
  - Student-led tutorials (42 h.)
  - Tutorials : Presentation of topics (2 h.) mid-course framing (2 h.), restitution and correction by a teacher-researcher (4 h.)
• Students on work-study programs (apprenticeships) :
  • Conducting the apprenticeship assignment(s) and the company.

Teaching methods:

-Students in initial training :

•  Practical work and Learning Lab: group and individual work

Students on work-study programs (apprenticeships) : 

• Conducting on-the-job training assignment(s)

Assessment methods: Report and oral presentation