Translating Nanomedicines – Basic Principles for Nanomedicines R&D

This course was designed to train researchers from Institutes and/or Industry in the field of Nanomedicines, providing the necessary knowledge to understand the manufacturing process, the scale-up process, as well as the main methodologies and techniques to characterise pharmaceutical quality attributes, and the non-clinical and clinical requirements of Nanomedicines.

The course will also address topics related to Regulatory Science, Ethics, Intellectual Property, and Patents in the field of Nanomedicines.

Coordination:
Ana Catarina Beco Pinto Reis, Associate Professor with Habilitation, Faculty of Pharmacy, University of Lisbon

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Legislation:

Regulamento n.º 638/2016 – Regulamento dos Cursos Não Conferentes de Grau da Faculdade de Farmácia da ULisboa

This course will take place from December 15 to December 19, 2025, and on January 6, 2026.

The course has a total workload of 26 hours, corresponding to 6 ECTS.

The training hours are distributed as follows:

• Theoretical hours: 21h

• Practical hours: 0h

• Laboratory hours: 0h

• Tutorial guidance: 5h

Schedule: Daytime

Course Venue: Faculty of Pharmacy, University of Lisbon (FFUL) and Faculty of Sciences, University of Lisbon (FCUL)

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COURSE PROGRAMME

• Contextualisation of the Nanomedicines R&D process (Phases; Market Context; Experimental Design in Preclinical and Clinical Research; Statistics applied to Health).

• Regulatory Framework of the Nanomedicines R&D process (Life cycle and its management; General Regulatory Framework for Medicines; Characterisation of the Manufacturing Process and Scale-up).

• Methodologies and Characterisation Techniques of quality attributes (I) and Non-clinical and Clinical issues (II): Basic principles of Dynamic Light Scattering, Electrophoretic Light Scattering, Spectroscopy, Photoluminescence, Nuclear Magnetic Resonance, Calorimetry, Microscopy, Immunohistochemistry, Blotting techniques, Flow cytometry, Cell culture and imaging techniques, in vitro/in vivo correlation, in silico models and pharmacokinetic modelling, in vivo models and Nanotoxicology.

• Intellectual Property, Technology Transfer, Patents, Ethics, Business Models, and Market Opportunities.

TEACHING METHODOLOGIES

Seminars and a written exam (1.5 h)

LEARNING OUTCOMES AND SKILLS TO BE ACQUIRED BY THE STUDENT

A series of seminars delivered by several lecturers from different areas (academia, pharmaceutical industry, regulatory bodies, European Patent Office, among others) will take place over 5 training days. The last day (Day 6) will be dedicated to assessment. The aim is for students to acquire multidisciplinary knowledge in the field of Nanomedicines and to autonomously systematise existing information based on scientific and technical literature, which will serve as the foundation for the development of a research project.

Students will also develop skills for independent research, both individually and in teams, as well as analytical and discussion skills regarding the economic consequences and the socio-cultural and ethical implications of research and development in Nanomedicines, including knowledge integration and the valorisation of patentable results or research outcomes with commercial exploitation potential.

Upon successful completion of the first module, in the second module the student will:

• Consolidate knowledge on Nanomedicines;

• Acquire skills in the use of methodologies and techniques for the characterisation of Nanomedicines;

• Enhance the ability to integrate acquired knowledge in the identification of suitable solutions to interdisciplinary problems;

• Stimulate the capacity for the independent selection and application of advanced experimental techniques to solve scientific and technological problems.

ASSESSMENT METHODOLOGY

80% of the final grade will correspond to the classification obtained in the Written Theoretical Exam (scale 0–20) and the remaining 20% to Continuous Assessment (scale 0–20). To pass, the final grade must be equal to or higher than 9.5.

The Written Theoretical Exam (1.5 h) will be structured as follows: Part I with 8 short-answer questions (8.0/20) and Part II with multiple-choice questions (12.0/20). To pass, the final grade must be equal to or higher than 9.5.

In Continuous Assessment, the following parameters will be considered: attendance, punctuality, engagement, and critical thinking. To pass, the final grade must be equal to or higher than 9.5.

An opportunity to improve the final grade is also foreseen. In this case, the PhD student will be required to take an oral exam.

Application Period: October 1 to November 30, 2025

Course Start and End Dates: December 15 to December 19, 2025, and January 6, 2026

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Entry Requirements

Competence in research in health-related sciences, pharmaceutical sciences, biology, biochemistry, medicine, biomedical engineering, among others.

Selection and Ranking Criteria

Submission of an updated CV.

• Minimum number of participants for course operation: 8
• Maximum number of participants for course operation: 25

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Fees and Tuition

• Application Fee: €10 (Note: The application fee is non-refundable if the applicant is excluded or not selected.)
• Course Tuition: €250
• Student Insurance: €2.10

Note: PhD students of FFUL who wish to take the course as part of their compulsory first-year curriculum are exempt from paying the application fee and course tuition.

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Application Process:

Applications for the course are made exclusively through the FenixEdu Platform of the Faculty of Pharmacy of the University of Lisbon (FFUL).

Access to the FenixEdu Platform:

• If you have never been a student at FFUL you must pre-register on the FenixEdu Platform.
• If you are a former student of FFULisboa and have already had an account campus@ulisboa or @edu.ulisboa.pt you should access the FenixEdu Platform and authenticate yourself with your account data. If you have lost access to your account, you can recover your password in the ULisboa users area.
• If you are a former student of FFULisboa and have never had an account campus@ulisboa or @edu.ulisboa.pt you must send an email to cncg@ff.ulisboa.pt indicating your full name and ID document number.

Access the FenixEdu Platform.

• On the tab “Candidate”, choose the type of application: “Advanced Training Courses”, select the desired course.
• Fill out the online form and attach all the required documents in digital format. In the application process you can indicate whether you want the invoice to be issued in the name of another entity/company/institution.
• Select the “Submit” option.

Applications will only be validated by the Academic Services once the applicant has paid the Application Fee.

For information regarding the organization of the course, please contact the Academic Services: doutoramentos@ff.ulisboa.pt

For scientific information regarding the teaching of the course, please contact the Course Coordination.