CPPS medicine

CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS / MEDICINES – MASTER 1&2

renseignements: Bernard Bataille

FROM CONCEPTION TO PRODUCTION
PROFESSIONS FOR THE HUMAN AND VETERINARY PHARMACY

A vocational training in the field of medicines

TO AQUIRE KNOWLEDGE

• Pre-formulation and formulation of the medicines,
• Conception (design) of the pharmaceutical forms,
• Pharmaceutical industrial processes,
• Production management and logistic,
• Project management.

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TO AQUIRE SKILLS

• To master the methods and tools: formulation, chemo metrics, technicity and equipment,
• Learning by problem solving: conception and preparation of a medicine, from the formula to the finished good.

 

PROFESSIONALIZATION AT THE CORE OF THE TRAINING COURSE

5 MONTH WORK PLACEMENT IN MASTER 1, 6 MONTH WORK PLACEMENT OR APPRENTICESHIP IN MASTER 2

EMPLOYMENT OPPORTUNITIES

GTechnologist/Formulator – Production sector manager – Methods manager

CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS

MEDICINE

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SKILLS ASSESSMENT GUIDELINES :

GOALS, CONTENTS AND TEACHERS FOR ALL TEACHING UNITS IN THIS COURSE :

MASTER 1 – prog 2015-2016

SEMESTER 1

TRONC COMMUN (S1)

TU 101 : REGULATORY AND FINANCIAL ASPECTS – QUALITY AND SAFETY

Goals:

Pharmaceutical law:

  • To know the various texts applying to the field of medicines, their origin, their legal value, their articulation
  • To have some knowledge of the various health products
  • To know the basics of innovation protection control, manufacturing, marketing and monitoring of medicines

Quality :

  • To know the quality demands and management tools

Security :

  • To know the regulations of ICPE classified installations
  • To know the classification and labelling of chemical products’ hazards

Marketing :

  • To integrate the marketing’s global approach
  • To know the diagnostic tools and the strategic directions

Financial analysis

  • To be able to analyse the profitability, the solvency and the liquidity of an economic activity (industrial company)

Content:

  • Pharmaceutical law (18hrs-Lecture)
  • Financial analysis (12hrs-Lecture)
  • Marketing (6hrs-Lecture)
  • Quality (10hrs-Lecture)
  • Safety (6hrs-Lecture)

Teachers:

  • V. RAGE-ANDRIEU
  • C. LE GAL
  • R. BARTHES
  • N. DELELIGNE
  • A. ESCANDE
  • V. BOISSERIE LAPORTE
  • O. VEYRET
  • A. GARD

TU 102: DATABASES – EPIDEMIOLOGY AND ENVIRONNEMENTAL HEALTH

Goals:

To comprehend epidemiological studies:

  • To identify epidemiology as public health tools
  • To know the epidemiological surveillance tools
  • To know the different types of epidemiological surveys
  • To be able to interpret descriptive epidemiology indicators
  • To be able to calculate and interpret the results of risk calculation (RR and OR) from analytical epidemiology
  • To be able to describe and criticise the strategies and protocols of studies implemented in epidemiology
  • To be able to assess the validity of screening tests
  • To know the behaviour and the impact of organic pollutants present in the environnement and to understand the related legislation

Databases:

  • To discover the basics of databases management
  • To understand how the information is structured thanks to the relational model
  • To recognise the different database usage patterns (administrator/client)
  • To be able to build a database including a few tables
  • To be able to define the main confines on a database
  • To be abe to use the main commands of the SQL language
  • To be autonomous on the data management system ACCESS (Microsoft)

Content:

  • Database (4hrs-Lecture+ 15hrs-Tutorial)
  • Epidemiology (12hrs-Lecture)
  • Environmental health (18hrs-Lecture)

Teachers:

  • M. VIVIEN
  • P. RAVEL
  • H. FENET
  • A. ESCANDE
  • F. COURANT
  • C. CASELLAS
  • E. GOMEZ

TU 103: HEALTH PRODUCTS DEVELOPMENT STRATEGY– PROJECT MANAGEMENT AND CLINICAL DEVELOPMENT

Goals:

  • General knowledge of the sectors of medicines, cosmetology and medical devices
  • Knowledge of the regulatory and socio-economic specificities of the medicines, cosmetology and medical devices
  • Initiation to the project management of health products development
  • Initiation to the proceedings of clinical trials in accordance with the Good Clinical Practices (GCP)

Content:

  • Development strategy: Medicines (12hrs-Lecture), Cosmetology (6hrs-Lecture) and Medical Devices (6hrs-Lectures)
  • Regulations in Europe, Japan and the United-States (6hrs-Lecture)
  • Clinical development (9hrs-Lecture)
  • Project management (6hrs-Lecture + 3hrs-Tutorial)

Teachers:

Montpellier University

  • B. BATAILLE
  • S. BEGU
  • J. COUDANE
  • X. GARRIC
  • A. EL GHAZOUI
  • P. CREMADES
  • W. AGOUMI

TU 104: BIOTECHNOLOGIES APPLIED TO HEALTH

Goals:

  • To know the various health products produced by biotechnologies
  • To acquire the notions of therapeutic targets and biomarkers
  • To acquire the notions of medium and high throughput screening
  • To know the technologies of recombinant DNA (GMO notion) and protein engineering
  • To know the production and quality control processes
  • To have a concrete overview of the conditions of production of a recombinant protein and of the development of a cellular model that is compatible with medium throughput screening (practical works carried out)

Content:

  • Identification of the molecular or cellular targets and of the biomarkers (8hrs-Lecture)
  • Production/Quality control (3hrs-Lecture)
  • Industrial applications/examples (11hrs-Lecture)
  • Virtual cloning (6hrs-Tutorial)
  • Production, purification, characterisation of a recombinant protein (12hrs-Practical work)
  • Preparation of a cellular model for medium throughput screening– visit of a high throughput pharmacological screening platform (10hrs-Practical work)

Teachers:

Montpellier University

  • S. CHAUMONT
  • A. CHOQUET
  • F. COURANT
  • S. DELBECQ
  • A-D. LAJOIX
  • X. GARRIC
  • S. MARY
  • F. MACARI-FINE
  • M.A. POUL

External professionals

  • ARPEGE Platform, IGF Montpellier

TU 105: FOREIGN LANGUAGES AND COMMUNICATION

Goals:

  • To develop communication skills in foreign languages
  • Specialized vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content:

  • Foreign languages (40hrs-Tutorial)
  • Communication (9hrs-Tutorial)

Teachers:

Montpellier University

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

External professionals

  • Communication consultancy

SPECIFIC TU:  CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS (S1)

TU 106 : PHYSICAL CHEMISTRY OF HEALTH PRODUCTS FORMULATION

Goals:

  • To understand and master the physical and physicochemical concepts necessary to the conception, the production, the formulation and the manufacturing of pharmaceutical, cosmetic and food-processing products

Content:

  • Polymorphism
  • Chemical and physical degradation of active principles
  • Mixtures’ thermodynamics
  • Definition, measurement and forecast of active principles’ solubility
  • Active principles solubilisation strategy
  • Physical stabilisation of multiphase systems
  • D.L.V.O theory
  • Rheology of complex matter

Teachers:

  • D. DURAND
  • A. EL GHZAOUI

SEMESTER 2

COMMON CORE (S2)

TU 201: ENGLISH AND SECOND LANGUAGE

Goals:

  • To develop communication skills in a foreign language
  • Specialised vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content: 40hrs

  • Work on all communication skills: written and oral expression and comprehension
  • Knowledge of the professional and cultural international environment
  • Job interview simulation, oral presentation using PowerPoint, meetings simulation, writing letters and emails, debates, documents reading etc.
  • Methodological aspects (according to the groups’ needs)
  • Practice on digital platform aiming at revising and strengthening language skills

Teachers:

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

TU 202: 3 to 5 MONTH WORK PLACEMENT

Goals:

  • To put into practice the skills gained during the training course
  • To achieve a concrete professional project within one’s context of activities

Content:

  • Preparation and instruction to find and complete a work placement (3hrs-Lecture)
  • 3 to 5 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • A. ESCANDE
  • E. GOMEZ
  • B. NOTTELET
  • X. GARRIC

SPECIFIC TU:  CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS (S2)

TU 203: RAW MATERIALS AND HEALTH PRODUCTS FORMULATION

Goals:

  • To understand the great principles and the formulation methodologies of health products (medicines and cosmetic products)
  • To know the main non active (excipients) and active (cosmetology) raw materials used in the formulation of health products:

– Medicines: excipients for the preparation of liquid, solid or semi-solid galenic forms. Materials and recipients for medicines’ packaging.

– Cosmetic products: raw materials for the formulation of the dispersed forms (emulsions, suspensions) leading to the conventional cosmetic forms (creams, cream-gels, washing products); Regulation and control of finished goods.

Content:

  • Lecture: 31hrs – Medicines / 15hrs – Cosmetology
  • Tutorial: 6hrs – Medicines / 2hrs – Cosmetology

Teachers:

  • B. BATAILLE
  • S. BEGU
  • M. DELALONDE
  • B. NOTTELET
  • T. SHARKAWI

TU 206: LEARNING BY PROJECT

Goals:

  • To introduce and train the students, through practice, to the conception, the preparation and the quality control of medicines.
  • To use equipment (of laboratory size) to conduct experimental work in accordance with the Good Manufacturing Practices.
  • To learn to work in a team and alone in a group under the authority of a  tutor/lecturer.
  • To learn to write experimental work reports and to present the methods and results in front of an audience.
  • To understand and describe the main stages of drawing up a medicines’ registration application. (Modules 3 of CTD multi-states file)

Content:

  • Face-to-face teaching – Team and personal work
  • Face-to-face teaching: practical work and tutorials (70hrs – Tutorial)
  • Team and personal work : drawing up work reports – oral presentations

Teachers:

  • B. BATAILLE
  • M. DELALONDE
  • E. RONDET
  • T. SHARKAWI
  • I. SOULAIROL

TU 207: MEDICINES ENGINEERING

Goals:

  • To address the Good Manufacturing Practices of medicines (European and international regulatory aspects) and the ICH guidelines regarding the production of medicines.
  • Introduction to the knwoledge and control of all unitary and coupled pharmaceutical operations: Industrial manufacturing of solid, liquid and semi-solid medicines and pharmaceutical products derived from biotechnologies
  • To address the main principles of pharmaceutical engineering
  • To address the main principles of equipment qualification and the validation of pharmaceutical industrial processes

Content:

  • Lectures : 50 hours

Teachers:

  • B. BATAILLE
  • M. DELALONDE
  • P. RAVEL
  • I. SOULAIROL
  • L. VACHOUD
  • T. SHARKAWI
MASTER 2 – prog 2016-2017

SEMESTER 3

COMMON CORE (S3)

TU 301: HEALTH PRODUCTS PROJECT MANAGEMENT, MANAGEMENT CONTROL AND PERFORMANCE MANAGEMENT

Goals:

Project management:

  • To understand the concepts, processes and project management methods within the frame described by the Project Management Institute
  • Operational planning: from analysing a project to the preparation of a feasible work schedule
  • To know the basic framework of innovation protection, manufacturing, the marketing and surveillance of medicines

Management control:

  • To assess and understand through an account of company’s results, the items of profitality and performance

MS Project:

  • To be able to use the MS Project software

Content:

  • Project management (12hrs- Lecture + 12hrs-Tutorial)
  • Management control and performance management (6hrs-Lecture + 6hrs-Tutorial)
  • MS Project software (12hrs-Tutorial)

Teachers:

Montpellier University

  • P. CREMADES
  • R. BARTHES

External professionals

  • Service provider

TU 302: QUALITY MANAGEMENT, MARKETING

Goals:

Team management:

  • To clarify the missions, roles and function of a team manager (project)
  • To understand the influence of one’s leadership of the team’s performance
  • To identify one’s management style, one’s negotiation style
  • To be able to lead a meeting

Quality management :

  • To master quality management

Marketing:

  • To understand the market’s mechanisms
  • To be able to identify the relevant stakeholders and to analyse the influence factors
  • To know the various strategic manoeuvres (by comparison with the demand and faced with the competition)
  • To be able to define the appropriate operational modes

Content:

  • Team management (12,5hrs-Tutorial)
  • Quality management (14hrs-Lecture + 12hrs-Tutorial)
  • Marketing (12hrs-Lecture)

Teachers:

  • R. BARTHES
  • N. DE LELIGNE
  • L. KABBARA BARDINA

SPECIFIC TU : CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS(S3)

TU 307: FORMULATION AND INDUSTRIAL PROCESSES

Goals:

To link the formulation issues (in-depth knowledge of the families and excipients features) to the industrial processes of medicines manufacturing, in particular:

  • Formulation and parenteral forms
  • Formulation and modified release solid oral forms
  • Formulation and ocular forms
  • Formulation and topical forms
  • Formulation and lyophilised forms
  • Formulation and biotechnologies

Content:

  • Lectures: 35 hrs
  • Tutorials (professional seminars) 5X3hrs (15hrs)
  • Personal work

Teachers :

  • B. BATAILLE
  • A. EL GHZAOUI
  • I. SOULAIROL

External professionals

  • External speakers

TU 308: LEARNING BY PROJECT

Goals:

  • To know, understand and master the functioning of a pharmaceutical company
  • To know and master the place of Galenic R&D, Transfer and production in a pharmaceutical company (international firms, subcontractors and generic manufacturers)
  • To be able to research information, to synthesise and present it

Content:

  • Lectures (10hrs)
  • Professional seminars (15hrs) (5X3hrs)
  • Mentored bibliographic project on an issue related to the goals (25hrs)

Teachers:

  • A. AUBERT
  • S. BEGU
  • M. MORILLE
  • B. BATAILLE
  • P-A. BONNET
  • I. SOULAIROL

TU 309: PRODUCTION PROCESSES AND OPERATIONAL QUALITY MANAGEMENT

Goals:

  • To master the processes and procedures (unitary operations and coupled operations) of the industrial manufacturing of medicines (conventional forms, innovative forms)
  • To master and apply the scale transposition methodologies
  • To master and apply the statistical tools (experiments planning, statistic control of the processes. To ensure their interpretation
  • To know and apply the production international regulation guidelines
  • To apply and master the methods and tools of quality assurance and management : quality of the equipment, validation of the processes, Quality by Design and PAT, risks analysis and management, audits/inspections, continuous improvement, Lean Manufacturing…)

Content:

  • Lectures : 70 hours
  • Tutorials : 30 hrs (10 sessions of 3 hrs)

Teachers:

  • B. BATAILLE
  • P. RAVEL
  • I. SOULAIROL
  • A. EL GHZAOUI

External professionals

  • External speakers

SEMESTER 4

COMMON CORE – STAGE (S4)

TU 401: 4 TO 6 MONTH WORK PLACEMENT

Goals:

  • To carry out a concrete professional project within its context of activities

Content:

  • 2hrs Lecture: preparation and instructions to find and do a work placement
  • 4 to 6 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • B. BEGU
  • P. RAVEL
  • M. VIVIEN
  • E. GOMEZ
  • X. GARRIC
  • A. EL GHZAOUI

SPECIFIC TU :CONCEPTION AND PRODUCTION OF HEALTH PRODUCTS(S4)

TU 404: LEARNING BY PROJECT

Goals:

  • To be able to conduct, lead and carry out a project of production equipment qualification, processes validation and scale transfer in accordance with international regulations.

Content:

  • Research and analysis of scientific documents on the project to be conducted (Tutorial: 10hrs)
  • Practical implementation of a qualification issue, validation and scale transfer (Tutorial/Practical work : 40hrs)

Teachers:

  • B. BATAILLE
  • A. AUBERT
  • I. SOULAIROL
  • S. BEGU
  • A. EL GHZAOUI
  • M. MORILLE
  • P. RAVEL

TU 405 : PRODUCTION MANAGEMENT AND PROMOTION

Goals:

  • To introduce the current methodologies and technical aspects in the field of purchasing including international purchasing, suppliers relationships as well as the logistic and supply chain management
  • To meet the companies’ needs regarding the recruitment of executives capable of conducting the development of goods and services exchanges within a globalised economy
  • To improve the knowledge in industrial property and patents

Content:

  • Lectures : 40 hrs
  • Tutorials : 5 sessions of 2 hours
  • Personal work

Teachers:

Montpellier University

  • D. TRAVAILLE

External professionals

  • External speakers