TEACHING PROGRAM
2024 – 2026

FIRST YEAR

first term (all students)

Students will study two terms in Italy and one term in either Spain or Belgium, according to whether the intellectual inclination of the student is towards preclinical or clinical research. Both Institutions, UMH and UNamur will present their program to students in Year 1.

SUBJECT ECTS* Teaching Unit Structure
Teaching (hours) Practicals (hours) Individual work (hours)
Anatomy and physiology of skin and appendages 18 12 70
Pathological mechanisms of skin disorders 5 24 12 89
Statistics, data analysis and epidemiology 5 24 12 89
Understanding R&D 2 12 38
Organic chemistry: theory and practice 6 24 24 102
Regulation of cosmetics, drugs and medical devices 3 18 57
Value assessment and market access 3 18 57
Total 28 138 60 502

* At UPO 1 ECTS = 25 hours

FIRST YEAR SUBJECTS – first term

 

  1. Anatomy and physiology of skin and appendages. The students will learn anatomy and histology of skin and appendages and the physiological mechanisms regulating the integumentary system. 4 ECTS (with laboratory)

Staff: M. Bosetti, D. Lim and guest lecturers 

 

  1. Pathological mechanisms of skin disorders. The students will learn the basis of mucosal immunity, the pathogenesis of inflammatory skin disorders, either autoimmune disorders or allergies, and the cellular and molecular mechanisms underlying wound healing. The students will also gain knowledge on the physiological microbiota of skin and on the principal pathogens associated with skin diseases. 5 ECTS (with laboratory)

Staff: L. Fracchia, C. Porta and guest lecturers

 

  1. Statistics, data analysis and epidemiology. Students will be introduced to the basic notions of statistics and probability. Topics discussed include describing data, basic probability and statistical inference. Students will also learn how to simulate, display and analyze data using suitable freely available software (for instance R). In addition, students will be provided the knowledge and skills to critically interpret and eventually perform systematic reviews of the literature and meta-analyses, as well as the basic principles of epidemiology to understand the therapeutic need. All these topics will be consolidated through examples and computer exercises. 5 ECTS (with practical sessions)

Staff: M. Rinaldi, S. Cargnin and F. Barone Adesi 

 

  1. Understanding R&D. The course is a general introduction to principles, challenges and hurdles to develop medicines. It will address some of the critical steps and bottlenecks in the R&D process with a focus on early drug discovery and preclinical research and their impact on clinical development of drug candidates. 2 ECTS

Staff: M.G. Grilli and guest lecturers

 

  1. Organic chemistry: theory and practice. The students will be introduced to the main functional groups and heterocycles, their electronic properties and reactivity. Selected examples of synthetic routes to pharmaceutical and cosmetic compounds will be illustrated. The main safety principles and techniques used for the practical synthesis of organic compounds (reaction setup, product isolation and purification) will be taught. 6 ECTS (with laboratory)

Staff: A. Minassi, T. Pirali, U. Galli and guest lecturers

 

  1. Regulation of cosmetics, drugs and medical devices. This unit will focus on the main issues regarding regulation and economics of the three different worlds and the differences between geographical regions. 4 ECTS

Staff: S. Morel and guest lecturers

 

  1. Value assessment and market access. the course aims at providing an overview of assessment and appraisal processes for medicines and other health technologies and how economic evaluation is used for market access purposes. The course will include (i) lectures focused on comparative assessment in the perspective of payers and economic evaluation; (ii) exercises on cost-effectiveness and budget impact analysis; (iii) case studies, referring to dermatological medicines, of clinical and economic evidence and its use for market access purposes. 3 ECTS

Staff: C. Jommi, A. Genazzani and guest lecturers

FIRST YEAR

second term (all students)

SUBJECT

ECTS

Teaching Unit Structure

Teaching (hours)

Practicals (hours)

Individual work (hours)

Medicinal chemistry and pharmacology of dermatological drugs

5

30

95

Protein science and molecular modelling

5

30

95

Principles of formulation

6

24

24

102

Dermatology

5

30

95

Analysis for quality control

3

12

12

51

Natural products and sustainability in R&D

6

18

36

96

Total

30

144

72

534

* At UPO 1 ECTS = 25 hours

FIRST YEAR SUBJECTS – second term

  1. Medicinal chemistry and pharmacology of dermatological drugs. The course will provide the students with the basic principles of drug discovery and development, from hit to lead. The design of prodrugs and soft drugs for topical use will be covered. Examples of successful stories of dermatological drugs will be presented from both a pharmacological and medicinal chemistry perspective.  5 ECTS

Staff: T. Pirali, F. Chiazza and guest lecturers

  1. Protein science and in silico drug discovery and design. The course will provide students with knowledge on proteins, their structure and function and the main biochemical techniques to study them. It will also illustrate the many ways we can describe, represent and visualize molecules in the computer, their binding to the target protein and the importance of recognizing and understanding the concept of similarity and the physicochemical and topological descriptors. 5 ECTS

Staff: A. Massarotti and R. Miggiano and guest lecturers

  1. Principles of formulation. The course will provide students with basic principles of formulation, with a focus on topical application of medications and cosmetics (creams, ointments, gels, colloids, patches and sunscreen formulations). 6 ECTS (with laboratory). 

Staff: L. Giovannelli and guest lecturers 

  1. Dermatology. The course aims to highlight the current unmet medical needs in dermatology.  The students receive knowledge on the dermatological symptoms and the clinical features of the main skin disorders, together with their current treatments. Moreover, the basis of cosmetic dermatology and cosmeceuticals will be presented, thus including their possible side effects. A brief focus on the newly-developed regenerative dermatology will also be provided. At the end of the course, the students are expected to know the scientific background in order to critically propose other possible drugs to be developed in the dermatology field. 5 ECTS

Staff: E. Zavattaro and guest lecturers

  1. Analysis for quality control. The course focuses on the fundamentals of quality assessment during product development and on the implementation of product stability testing according to the regulatory guidance. Practical laboratory activity includes sample preparation and instrumental analysis (HPLC) for the assessment of active pharmaceutical ingredients (APIs) purity and formulations stability. 3 ECTS (with laboratory) 

Staff: E. Del Grosso, S. Aprile and guest lecturers

  1. Natural products and sustainability in R&D. Students will learn what a secondary metabolite is and why plants produce them. They will learn classifications of natural compounds and the possible interaction with our biology. The course will also focus on strategies used by the productive world to increase sustainability, both in the pharmaceutical and cosmetic fields. 6 ECTS (with laboratory)

Staff: F. Pollastro and guest lecturers

WORKSHOP

SUBJECT

YEAR/TERM

ECTS

Teaching Unit Structure 

Seminars (hours)

Practicals (hours)

Individual work (hours)

An introduction to the markets of cosmetic products, dermatological drugs and medical devices

I/I (Italy, UPO)

2

12

38

An introduction to the markets of cosmetic products, dermatological drugs and medical devices. This workshop will introduce students to the skin health and care industry, the main areas of investment of companies, as well as to the world of marketing. Introductory lectures on sustainability, equality, leadership and public engagement will also be delivered. The evaluation will be based on the participation in a project focused on the communication of science to the general public through a website managed by the students. 2 ECTS

SECOND YEAR

first term (OPTION A – UMH)
Non-clinical Development

SUBJECT ECTS* Teaching Unit Structure
Teaching (hours) Practicals (hours) Individual work (hours)
Development of new skin care products 3 12 12 51
Analytical techniques for skincare products and ingredients 4 12 24 64
In vitro skin models for testing and evaluation 7 18 48 109
Safety evaluation 3 12 12 51
New technologies in skin care products design and development 3 12 12 51
Total 20 66 108 326

* At UMH 1 ECTS = 25 hours

SECOND YEAR SUBJECTS – OPTION A

 

  1. Development of new skin care products. In this course, students will learn the principles to develop bioactive molecules into products based on solid science that includes the use of new technologies for the search of targets with relevant role in skin care, the use of biotechnology ingredients, genetic profiling for individual skin care, products based on stem cells and cell regeneration, or cell and tissue engineering. This course also includes the introduction of new products to the market, value proposition and product value development. 3 ECTS (with laboratory)

Staff: Antonio Ferrer Montiel, Asia Fernández Carvajal and guest lecturers

  1. Analytical techniques for skincare products and ingredients. It will provide the theoretical and practical basis of the main techniques used for the analytical and physicochemical characterization of cosmetic ingredients and products, including allergen and contaminants determinations and Good Laboratory Practices principles. An introduction to OMICS approaches and how to use them within cosmetic product development and characterization will also be included. 4 ECTS (with laboratory)

Staff: Enrique Barrajón-Catalán, Vicente Micol and guest lecturers

  1. In vitro skin models for testing and evaluation. The main aim of this course is to provide the knowledge necessary to design, develop and validate bioactive compounds from library screenings to cosmetic and dermatological applications to obtain effective and stable products for exploitation. At the end of the laboratory, the students will be familiar with the most up-to-date cellular and multicellular in vitro models employed to assess the efficacy, safety, and mechanism of action of bioactive molecules and other ingredients. 7 ECTS (with laboratory)

Staff: Maria Herranz, Enrique Barrajon, Asia Fernandez Carvajal, Gregorio Fernández Ballester, Isabel Devesa, and guest lecturers

4. Safety Evaluation. The course will address potential off-target effects as well as knowledge on how to perform safety assessments and toxicological profiles of cosmetic and dermatological products, evaluating the risks of their application to healthy human skin under normal and foreseeable use conditions. 3 ECTS (with laboratory)

Staff:  Isabel Devesa, Veronica Rivero, Enrique Barrajon, and guest lecturers

  1. New technologies in skin care products design and development. At the end of this course the student will have acquired the necessary knowledge for the use of advanced technologies in the design of new skin care products ranging from the creation of validation models of active products such as skin-on-a-chip, to the use of artificial intelligence to design customized products, including the use of nanotechnologies to achieve more effective and targeted products. The importance of maintaining macrobiotic homeostasis in skin balance and treatment will also be addressed. 3 ECTS (with laboratory)

Staff: Antonio Ferrer Montiel, Asia Fernandez Carvajal, Enrique Barrajon and guest lecturers. 

TUTORED WORK

 

YEAR

TERM

ECTS

TOTAL HOURS

Protecting intellectual property and starting up a company

Second

First

4

100

Design thinking to problem solving

Second

First

3

75

Protecting intellectual property and starting up a company. Students will receive mentoring on the scientific and business aspects of the project. From the process of protecting intellectual property and obtaining patents, to the development of a business plan for a potential new company based on the production of new skin care products. They will also receive advice on the different types of innovation and how to attract investments by business angels and venture capitals. The project will culminate with a presentation by the students to non-academic professionals who will play the role of investors during the workshop “Business Plan and Entrepreneurship”. 4 ECTS

Design thinking to problem solving. The objective is to give students the tools to solve complex problems. They will work in groups with an interdisciplinary background in an environment that facilitates creativity. As a team, their goal is to pose the right questions in order to develop solutions that convince the user. With this approach, the team moves forward in the following order: understand the problem and observe the starting situation, develop and refine ideas on the topic, implement them, learn about the process and design in a user-friendly way oriented to the requirements of the target audience. 3 ECT

WORKSHOP

SUBJECT YEAR/TERM ECTS Teaching Unit Structure  
      Seminars (hours) Practicals (hours) Individual work (hours)
Business Plan and Entrepreneurship II/I (Spain, UMH) 3 18 57

Business Plan and Entrepreneurship – The students will receive lectures from non-academic professionals relating to the ideation and construction of businesses centered on cosmetic and pharmaceutical products, with examples of success stories as well as failures. Part of the time will also be dedicated to the presentations by students on their tutored work “Protecting intellectual property and starting up a company”. 3 ECTS

SECOND YEAR

first term (OPTION B – UNamur)
Clinical Development

SUBJECT

ECTS

Teaching Unit Structure

 

 

 

Teaching (hours)

Practicals (hours)

Individual work (hours)

Clinical trials

6

24 + 30

 

126

Quality assurance: GMP, GCP, GLP and auditing

3

24

 

66

Bioethics

2

20

 

40

Critical Analysis of Clinical Trials

3

20

 

70

Clinical research associate training

2

15

 

45

Clinical project management

2

12

 

48

Biomarkers and surrogate markers in clinical dermatology trials

2

12

 

48

Meta-analysis of interventional studies

3

24

 

66

Total

23

181

 

509

 

* At UNamur 1 ECTS = 30 hours

SECOND YEAR SUBJECTS – OPTION B

 

1. Clinical trials. This course will allow students to explore fundamental concepts related to clinical trials while maintaining a broad and interdisciplinary approach to clinical trials beyond pure pharmacological studies, enabling the application of these concepts across various fields and disciplines. The course will be designed to equip students with enough knowledge to foster a critical mindset towards the methodologies employed in clinical trials. At the end of this course, student 1) will be familiar with the major principles of research adopted in clinical trials; 2) will be able to recognize the different types of clinical trials and understand the key methodological aspects of these various trial types; 3) will grasp the various key components of a clinical trial protocol and be capable of critically reviewing it; 4) will comprehend the main statistical analyses applied in clinical trials and be able to interpret them; 5) will be able to analyze potential methodological biases that may be present in a clinical trial ; 6)  will be familiar with  good clinical practice (GCP) and good research practices (EQUATOR); 7) will understand the importance of publishing the results of a clinical trial and will have gained a foundation in meta-research in the field of clinical trials. 6 ECTS (with tutorials and visits)

Staff: C. Beaudart

2. Quality assurance: GMP, GCP, GLP and auditing. The principles of quality assurance in the field of healthcare and drug development are depicted. The international standard ISO17025 is reviewed in detail to give a complete overview of a quality system with organizational and technical requirements. The different GxP standards will be covered: GLP (good laboratory practices) for the pre-clinical studies; GCP (good clinical practices) and GCLP (good clinical laboratory practices) for the clinical studies; GMP (good manufacturing practices) and GDP (good distribution practices) for drug production and distribution. Finally, the students will be introduced to the concept of validation in the broad sense of the term, to cover all the topics concerned by qualification or validation needs. 3 ECTS 

Staff: P. Lienard 

3. Bioethics. This course will illustrate the ethical requirements for the conduction of clinical trials in contemporary science, also giving an overview of historical pillars that brought legislations and opinions to change. 2 ECTS (with tutorials)

Staff: L. Ravez 

4. Critical analysis of clinical trials. Using a Problem Based Learning educational format approach, this course will allow the students to develop their critical skills in regards of clinical trials planification, execution and reporting. As examples, they will learn to identify the key factors that can lead to the failure of a clinical trial and will be able to identify potential solutions to avoid these failures. They will also learn about the issues and strategies related to research transparency requirements. 3 ECTS

Staff: C. Beaudart 

5. Clinical research associate training. The course will provide students with the basic training required for clinical research associates. The course has the added value of allowing students to undertake an internship in a clinical research organization according to EU legislation, if in their will. 2 ECTS 

Staff: C. Beaudart, K. Vanorshoven (guest lecturer), I. Brenes (guest lecturer)

6. Clinical project management. The students will be introduced to the role, skills and responsibilities of a Clinical Project Manager (hard skills, soft skills and how to optimize clinical trials). The course will be structured around five main stages in research projects:1/Initiating; 2/ Planning; 3/ Executing; 4/ Monitoring and controlling; 5/ Analysis and reporting. 2 ECTS 

Staff: C. Beaudart

7. Biomarkers and surrogate markers in clinical dermatology trials. Students will be able to discriminate a biomarker from a surrogate marker in the context of regulatory affairs and their importance in the interpretation of clinical trials in dermatology. 2 ECTS 

Staff: F. Libon

8. Meta-analysis of interventional studies. This course will enable students to explore the world of meta-analysis. By combining the results of multiple interventional trials using meta-analytic models, students will be able to understand the significance of these result models in health decisions. By the end of this course, students will have grasped the major methodological and statistical points of meta-analyses and will be capable of critically interpreting the results of a meta-analysis. 3 ECTS 

Staff: C. Beaudart

TUTORED WORK

  YEAR TERM ECTS TOTAL HOURS
A case of study of clinical trials Second First 4 120

Case study of clinical trials Students will be asked to design a clinical development (Phase I, Phase II, and Phase III study) for a drug which has just completed pre-clinical investigations. Students will be divided in small groups (2-3). The Case Study will be presented during the workshop “Dermatology in the 21st century”. 4 ECTS

WORKSHOP

SUBJECT YEAR/TERM ECTS Teaching Unit Structure  
      Seminars Practicals (hours) Individual work (hours)
Dermatology in 21st century II/I (Belgium, UNAMUR) 3 18 72

 

Dermatology in the 21st century – This workshop aims to present cutting-edge developments in the dermatology field: 3D skin models (organ-on-a-chip), personalized medicines for skin infections and cancer, medical devices and regulation. The topic of the seminars will vary each year and will be chosen based on current discoveries. During the workshop students will present their Case Study performed during the tutored work. 3 ECTS

SECOND YEAR

second term
FINAL ELECTIVE PROJECT

  YEAR TERM ECTS WEEKS
INTERNSHIP Second Fourth 30 22 to 26

During the fourth term, Students will complete a final elective project at a research laboratory in Universit, or in an industry or in a research center, write the thesis and do the oral dissertation, as described in the “Internship Guidelines” UMH and UNamur are responsible to sign and arrange agreements and to manage the traineeships. 30 ECTS

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TEACHING PROGRAM
2024 – 2026

FIRST YEAR

first term
(all students)

Students will study two terms in Italy and one term in either Spain or Belgium, according to whether the intellectual inclination of the student is towards preclinical or clinical research. Both Institutions, UMH and UNamur will present their program to students in Year 1.

SUBJECT ECTS* Teaching Unit Structure
Teaching (hours) Practicals (hours) Individual work (hours)
Anatomy and physiology of skin and appendages 18 12 70
Pathological mechanisms of skin disorders 5 24 12 89
Statistics, data analysis and epidemiology 5 24 12 89
Understanding R&D 2 12 38
Organic chemistry: theory and practice 6 24 24 102
Regulation of cosmetics, drugs and medical devices 3 18 57
Value assessment and market access  3 18 57
Total 28 138 60 502

* At UPO 1 ECTS = 25 hours

FIRST YEAR SUBJECTS – first term

 

  1. Anatomy and physiology of skin and appendages. The students will learn anatomy and histology of skin and appendages and the physiological mechanisms regulating the integumentary system. 4 ECTS (with laboratory)

Staff: M. Bosetti, D. Lim and guest lecturers 

 

  1. Pathological mechanisms of skin disorders. The students will learn the basis of mucosal immunity, the pathogenesis of inflammatory skin disorders, either autoimmune disorders or allergies, and the cellular and molecular mechanisms underlying wound healing. The students will also gain knowledge on the physiological microbiota of skin and on the principal pathogens associated with skin diseases. 5 ECTS (with laboratory)

Staff: L. Fracchia, C. Porta and guest lecturers

 

  1. Statistics, data analysis and epidemiology. Students will be introduced to the basic notions of statistics and probability. Topics discussed include describing data, basic probability and statistical inference. Students will also learn how to simulate, display and analyze data using suitable freely available software (for instance R). In addition, students will be provided the knowledge and skills to critically interpret and eventually perform systematic reviews of the literature and meta-analyses, as well as the basic principles of epidemiology to understand the therapeutic need. All these topics will be consolidated through examples and computer exercises. 5 ECTS (with practical sessions)

Staff: M. Rinaldi, S. Cargnin and F. Barone Adesi 

 

  1. Understanding R&D. The course is a general introduction to principles, challenges and hurdles to develop medicines. It will address some of the critical steps and bottlenecks in the R&D process with a focus on early drug discovery and preclinical research and their impact on clinical development of drug candidates. 2 ECTS

Staff: M.G. Grilli and guest lecturers

 

  1. Organic chemistry: theory and practice. The students will be introduced to the main functional groups and heterocycles, their electronic properties and reactivity. Selected examples of synthetic routes to pharmaceutical and cosmetic compounds will be illustrated. The main safety principles and techniques used for the practical synthesis of organic compounds (reaction setup, product isolation and purification) will be taught. 6 ECTS (with laboratory)

Staff: A. Minassi, T. Pirali, U. Galli and guest lecturers

 

  1. Regulation of cosmetics, drugs and medical devices. This unit will focus on the main issues regarding regulation and economics of the three different worlds and the differences between geographical regions. 4 ECTS

Staff: S. Morel and guest lecturers

 

  1. Value assessment and market access. the course aims at providing an overview of assessment and appraisal processes for medicines and other health technologies and how economic evaluation is used for market access purposes. The course will include (i) lectures focused on comparative assessment in the perspective of payers and economic evaluation; (ii) exercises on cost-effectiveness and budget impact analysis; (iii) case studies, referring to dermatological medicines, of clinical and economic evidence and its use for market access purposes. 3 ECTS

Staff: C. Jommi, A. Genazzani and guest lecturers

FIRST YEAR

second term (all students)

SUBJECT

ECTS

Teaching Unit Structure

Teaching (hours)

Practicals (hours)

Individual work (hours)

Medicinal chemistry and pharmacology of dermatological drugs

5

30

95

Protein science and molecular modelling

5

30

95

Principles of formulation

6

24

24

102

Dermatology

5

30

95

Analysis for quality control

3

12

12

51

Natural products and sustainability in R&D

6

18

36

96

Total

30

144

72

534

* At UPO 1 ECTS = 25 hours

FIRST YEAR SUBJECTS – second term

  1. Medicinal chemistry and pharmacology of dermatological drugs. The course will provide the students with the basic principles of drug discovery and development, from hit to lead. The design of prodrugs and soft drugs for topical use will be covered. Examples of successful stories of dermatological drugs will be presented from both a pharmacological and medicinal chemistry perspective.  5 ECTS

Staff: T. Pirali, F. Chiazza and guest lecturers

  1. Protein science and molecular modelling. The course will provide students with knowledge on proteins, their structure and function and the main biochemical techniques to study them. It will also illustrate the many ways we can describe, represent and visualize molecules in the computer, their binding to the target protein and the importance of recognizing and understanding the concept of similarity and the physicochemical and topological descriptors. 5 ECTS

Staff: A. Massarotti and R. Miggiano and guest lecturers

  1. Principles of formulation. The course will provide students with basic principles of formulation, with a focus on topical application of medications and cosmetics (creams, ointments, gels, colloids, patches and sunscreen formulations). 6 ECTS (with laboratory). 

Staff: L. Giovannelli and guest lecturers 

  1. Dermatology. The course aims to highlight the current unmet medical needs in dermatology.  The students receive knowledge on the dermatological symptoms and the clinical features of the main skin disorders, together with their current treatments. Moreover, the basis of cosmetic dermatology and cosmeceuticals will be presented, thus including their possible side effects. A brief focus on the newly-developed regenerative dermatology will also be provided. At the end of the course, the students are expected to know the scientific background in order to critically propose other possible drugs to be developed in the dermatology field. 5 ECTS

Staff: E. Zavattaro and guest lecturers

  1. Analysis for quality control. The course focuses on the fundamentals of quality assessment during product development and on the implementation of product stability testing according to the regulatory guidance. Practical laboratory activity includes sample preparation and instrumental analysis (HPLC) for the assessment of active pharmaceutical ingredients (APIs) purity and formulations stability. 3 ECTS (with laboratory) 

Staff: E. Del Grosso, S. Aprile and guest lecturers

  1. Natural products and sustainability in R&D. Students will learn what a secondary metabolite is and why plants produce them. They will learn classifications of natural compounds and the possible interaction with our biology. The course will also focus on strategies used by the productive world to increase sustainability, both in the pharmaceutical and cosmetic fields. 6 ECTS (with laboratory)

Staff: F. Pollastro and guest lecturers

WORKSHOP

SUBJECT

YEAR/TERM

ECTS

Teaching Unit Structure 

Seminars (hours)

Practicals (hours)

Individual work (hours)

An introduction to the markets of cosmetic products, dermatological drugs and medical devices

I/I (Italy, UPO)

2

12

38

An introduction to the markets of cosmetic products, dermatological drugs and medical devices. This workshop will introduce students to the skin health and care industry, the main areas of investment of companies, as well as to the world of marketing. Introductory lectures on sustainability, equality, leadership and public engagement will also be delivered. The evaluation will be based on the participation in a project focused on the communication of science to the general public through a website managed by the students. 2 ECTS

SECOND YEAR

first term
(OPTION A – UMH)
Non-clinical Development

SUBJECT ECTS* Teaching Unit Structure
Teaching (hours) Practicals (hours) Individual work (hours)
Development of new skin care products 3 12 12 51
Analytical techniques for skincare products and ingredients 4 12 24 64
In vitro skin models for testing and evaluation 7 18 48 109
Safety evaluation 3 12 12 51
New technologies in skin care products design and development 3 12 12 51
Total 20 66 108 326

* At UMH 1 ECTS = 25 hours

SECOND YEAR SUBJECTS – OPTION A

 

  1. Development of new skin care products. In this course, students will learn the principles to develop bioactive molecules into products based on solid science that includes the use of new technologies for the search of targets with relevant role in skin care, the use of biotechnology ingredients, genetic profiling for individual skin care, products based on stem cells and cell regeneration, or cell and tissue engineering. This course also includes the introduction of new products to the market, value proposition and product value development. 3 ECTS (with laboratory)

Staff: Antonio Ferrer Montiel, Asia Fernández Carvajal and guest lecturers

  1. Analytical techniques for skincare products and ingredients. It will provide the theoretical and practical basis of the main techniques used for the analytical and physicochemical characterization of cosmetic ingredients and products, including allergen and contaminants determinations and Good Laboratory Practices principles. An introduction to OMICS approaches and how to use them within cosmetic product development and characterization will also be included. 4 ECTS (with laboratory)

Staff: Enrique Barrajón-Catalán, Vicente Micol and guest lecturers

  1. In vitro skin models for testing and evaluation. The main aim of this course is to provide the knowledge necessary to design, develop and validate bioactive compounds from library screenings to cosmetic and dermatological applications to obtain effective and stable products for exploitation. At the end of the laboratory, the students will be familiar with the most up-to-date cellular and multicellular in vitro models employed to assess the efficacy, safety, and mechanism of action of bioactive molecules and other ingredients. 7 ECTS (with laboratory)

Staff: Maria Herranz, Enrique Barrajon, Asia Fernandez Carvajal, Gregorio Fernández Ballester, Isabel Devesa, and guest lecturers

4. Safety Evaluation. The course will address potential off-target effects as well as knowledge on how to perform safety assessments and toxicological profiles of cosmetic and dermatological products, evaluating the risks of their application to healthy human skin under normal and foreseeable use conditions. 3 ECTS (with laboratory)

Staff:  Isabel Devesa, Veronica Rivero, Enrique Barrajon, and guest lecturers

  1. New technologies in skin care products design and development. At the end of this course the student will have acquired the necessary knowledge for the use of advanced technologies in the design of new skin care products ranging from the creation of validation models of active products such as skin-on-a-chip, to the use of artificial intelligence to design customized products, including the use of nanotechnologies to achieve more effective and targeted products. The importance of maintaining macrobiotic homeostasis in skin balance and treatment will also be addressed. 3 ECTS (with laboratory)

Staff: Antonio Ferrer Montiel, Asia Fernandez Carvajal, Enrique Barrajon and guest lecturers. 

TUTORED WORK

 

YEAR

TERM

ECTS

TOTAL HOURS

Protecting intellectual property and starting up a company

Second

First

4

100

Design thinking to problem solving

Second

First

3

75

Protecting intellectual property and starting up a company. Students will receive mentoring on the scientific and business aspects of the project. From the process of protecting intellectual property and obtaining patents, to the development of a business plan for a potential new company based on the production of new skin care products. They will also receive advice on the different types of innovation and how to attract investments by business angels and venture capitals. The project will culminate with a presentation by the students to non-academic professionals who will play the role of investors during the workshop “Business Plan and Entrepreneurship”. 4 ECTS

Design thinking to problem solving. The objective is to give students the tools to solve complex problems. They will work in groups with an interdisciplinary background in an environment that facilitates creativity. As a team, their goal is to pose the right questions in order to develop solutions that convince the user. With this approach, the team moves forward in the following order: understand the problem and observe the starting situation, develop and refine ideas on the topic, implement them, learn about the process and design in a user-friendly way oriented to the requirements of the target audience. 3 ECT

WORKSHOP

SUBJECT YEAR/TERM ECTS Teaching Unit Structure  
      Seminars (hours) Practicals (hours) Individual work (hours)
Business Plan and Entrepreneurship II/I (Spain, UMH) 3 18 57

Business Plan and Entrepreneurship – The students will receive lectures from non-academic professionals relating to the ideation and construction of businesses centered on cosmetic and pharmaceutical products, with examples of success stories as well as failures. Part of the time will also be dedicated to the presentations by students on their tutored work “Protecting intellectual property and starting up a company”. 3 ECTS

SECOND YEAR

first term
(OPTION B – UNamur)
Clinical Development

SUBJECT

ECTS

Teaching Unit Structure

 

 

 

Teaching (hours)

Practicals (hours)

Individual work (hours)

Clinical trials

6

24 + 30

 

126

Quality assurance: GMP, GCP, GLP and auditing

3

24

 

66

Bioethics

2

20

 

40

Critical Analysis of Clinical Trials

3

20

 

70

Clinical research associate training

2

15

 

45

Clinical project management

2

12

 

48

Biomarkers and surrogate markers in clinical dermatology trials

2

12

 

48

Meta-analysis of interventional studies

3

24

 

66

Total

23

181

 

509

 

* At UNamur 1 ECTS = 30 hours

SECOND YEAR SUBJECTS – OPTION B

 

1. Clinical trials. This course will allow students to explore fundamental concepts related to clinical trials while maintaining a broad and interdisciplinary approach to clinical trials beyond pure pharmacological studies, enabling the application of these concepts across various fields and disciplines. The course will be designed to equip students with enough knowledge to foster a critical mindset towards the methodologies employed in clinical trials. At the end of this course, student 1) will be familiar with the major principles of research adopted in clinical trials; 2) will be able to recognize the different types of clinical trials and understand the key methodological aspects of these various trial types; 3) will grasp the various key components of a clinical trial protocol and be capable of critically reviewing it; 4) will comprehend the main statistical analyses applied in clinical trials and be able to interpret them; 5) will be able to analyze potential methodological biases that may be present in a clinical trial ; 6)  will be familiar with  good clinical practice (GCP) and good research practices (EQUATOR); 7) will understand the importance of publishing the results of a clinical trial and will have gained a foundation in meta-research in the field of clinical trials. 6 ECTS (with tutorials and visits)

Staff: C. Beaudart

2. Quality assurance: GMP, GCP, GLP and auditing. The principles of quality assurance in the field of healthcare and drug development are depicted. The international standard ISO17025 is reviewed in detail to give a complete overview of a quality system with organizational and technical requirements. The different GxP standards will be covered: GLP (good laboratory practices) for the pre-clinical studies; GCP (good clinical practices) and GCLP (good clinical laboratory practices) for the clinical studies; GMP (good manufacturing practices) and GDP (good distribution practices) for drug production and distribution. Finally, the students will be introduced to the concept of validation in the broad sense of the term, to cover all the topics concerned by qualification or validation needs. 3 ECTS 

Staff: P. Lienard 

3. Bioethics. This course will illustrate the ethical requirements for the conduction of clinical trials in contemporary science, also giving an overview of historical pillars that brought legislations and opinions to change. 2 ECTS (with tutorials)

Staff: L. Ravez 

4. Critical analysis of clinical trials. Using a Problem Based Learning educational format approach, this course will allow the students to develop their critical skills in regards of clinical trials planification, execution and reporting. As examples, they will learn to identify the key factors that can lead to the failure of a clinical trial and will be able to identify potential solutions to avoid these failures. They will also learn about the issues and strategies related to research transparency requirements. 3 ECTS

Staff: C. Beaudart 

5. Clinical research associate training. The course will provide students with the basic training required for clinical research associates. The course has the added value of allowing students to undertake an internship in a clinical research organization according to EU legislation, if in their will. 2 ECTS 

Staff: C. Beaudart, K. Vanorshoven (guest lecturer), I. Brenes (guest lecturer)

6. Clinical project management. The students will be introduced to the role, skills and responsibilities of a Clinical Project Manager (hard skills, soft skills and how to optimize clinical trials). The course will be structured around five main stages in research projects:1/Initiating; 2/ Planning; 3/ Executing; 4/ Monitoring and controlling; 5/ Analysis and reporting. 2 ECTS 

Staff: C. Beaudart

7. Biomarkers and surrogate markers in clinical dermatology trials. Students will be able to discriminate a biomarker from a surrogate marker in the context of regulatory affairs and their importance in the interpretation of clinical trials in dermatology. 2 ECTS 

Staff: F. Libon

8. Meta-analysis of interventional studies. This course will enable students to explore the world of meta-analysis. By combining the results of multiple interventional trials using meta-analytic models, students will be able to understand the significance of these result models in health decisions. By the end of this course, students will have grasped the major methodological and statistical points of meta-analyses and will be capable of critically interpreting the results of a meta-analysis. 3 ECTS 

Staff: C. Beaudart

TUTORED WORK

  YEAR TERM ECTS TOTAL HOURS
A case of study of clinical trials Second First 4 120

Case study of clinical trials Students will be asked to design a clinical development (Phase I, Phase II, and Phase III study) for a drug which has just completed pre-clinical investigations. Students will be divided in small groups (2-3). The Case Study will be presented during the workshop “Dermatology in the 21st century”. 4 ECTS

WORKSHOP

SUBJECT YEAR/TERM ECTS Teaching Unit Structure  
      Seminars Practicals (hours) Individual work (hours)
Dermatology in 21st century II/I (Belgium, UNAMUR) 3 18 72

 

Dermatology in the 21st century – This workshop aims to present cutting-edge developments in the dermatology field: 3D skin models (organ-on-a-chip), personalized medicines for skin infections and cancer, medical devices and regulation. The topic of the seminars will vary each year and will be chosen based on current discoveries. During the workshop students will present their Case Study performed during the tutored work. 3 ECTS

SECOND YEAR

second term
FINAL ELECTIVE PROJECT

  YEAR TERM ECTS WEEKS
INTERNSHIP Second Fourth 30 22 to 26

During the fourth term, Students will complete a final elective project at a research laboratory in Universit, or in an industry or in a research center, write the thesis and do the oral dissertation, as described in the “Internship Guidelines” UMH and UNamur are responsible to sign and arrange agreements and to manage the traineeships. 30 ECTS

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Last modified: December 14, 2023

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Education and Culture Executive Agency (EACEA). Neither the European Union nor EACEA can be held responsible for them.

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