CPPS drug

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 : 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.

Contents

• 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

Speakers

DURANT Denis
EL GHZAOUI Abdeslam
VAN DEN BERGHE Hélèn

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 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

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 ofTU :

• 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

Prerequisite:

• 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 ofTU :

• 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

Prerequisite:

• 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 ofTU :

• 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 plans

Number of ECTS = 5 -Responsible TU :SOULAIROL Ian

Prerequisite:

• 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 ofTU :

• 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 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 = 5 - Manager TU : SOULAIROL Ian

Prerequisite:

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

• 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

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 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 ofTU :

• 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 Bernar
• 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

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 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 ofTU :

• 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

Prerequisite:

• 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 ofTU :

• Synthesis, critical analysis and feedback on ICH "Quality" guidelines - Specific analysis of guidelines Q8, Q9 and Q10
  - Student-led tutorials (42 h.)
  - Student-led tutorials : 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 = 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 = 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 ofTU :

• - 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

Evaluation methods: Written test - Continuous assessment

Number of ECTS = 2 -Responsible TU :SOULAIROL Ian

Prerequisite:

• 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 estimate needs, availability and capacity as accurately as possible, in order to better synchronize the elements of the global supply and manufacturing chain.

Contents ofTU :

• 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 leadership

OBJECTIVES

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