Regulatory Affairs for Medicines and Health Products

POST-GRADUATE STUDIES

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ABOUT THE COURSE

Online Edition

The postgraduate course in regulatory affairs aims to prepare highly qualified professionals in regulatory affairs related to the areas of pharmaceuticals, medical devices, cosmetic and personal hygiene products, and food supplements, to work in different areas of regulatory affairs.

This course is aimed at pharmacists, doctors, dentists, and other health and healthcare professionals who wish to increase their knowledge in the area of regulatory affairs related to medicines, medical devices, cosmetic products, and food supplements.

The course will run with a minimum of 10 and a maximum of 30 students.

Total duration of 60 hours, 5 ECTS credits.

Total: 250 hours (60 ECTS).
Courses: 196 hours (in blended learning – 140 in-person + 56 online)
Seminars: (in blended learning – 8 in-person + 12 online)
Monograph (Individual MBA completion work)

Online Course
Fridays: 2:30 PM – 6:30 PM

Some of the supplementary seminars for each module may be held on Saturday mornings.

Final Assessment: Students will be required to submit a final paper/report on one of the topics covered during the course.

The course will be proposed for certification by the Order of Pharmacists for the purposes of Continuing Professional Development.

Program Content

Course Content:

1. European medicines system - main legal instruments.
European Medicines Agency. Infarmed IP. Medicines supply chain and the main legal regulations governing it. Medicines market.
Duration: 2 hours
Lecturer: Eurico Castro Alves and Hélder Mota Filipe

2. Pharmaceutical product. Marketing Authorization Procedures. Technical Document – Common
Duration: 2 hours
Lecturer: Hélder Mota Filipe and Pedro Barata

3. CTD Module 3 – Quality Assessment of Active Substances and Pharmaceutical Forms. BD/BE.
Duration: 4 hours
Lecturers: Domingos Ferreira* and Gilberto Alves*

4. CTD Module 4 – Non-Clinical Drug Evaluation
Duration: 2 hours
Lecturer: Félix Carvalho*

5. CTD Module 5 – Clinical Evaluation of Medications
Duration: 2 hours
Lecturer: Ana Povo

6. New Regulation on Veterinary Medicines
Duration: 4 hours
Lecturers: Inês Almeida and Carla Martins Lopes

Total: 12 teaching hours / 25 total hours
1 ECTS

Skills to Acquire:
• Understanding the European drug supply chain and system
• To know, interpret, and prepare a common technical document.
• To understand the process and methodology for evaluating health technologies.

*to be confirmed
Course Content:

1. Fundamentals of Pharmacoeconomics. Health Technology Assessment Methodologies.
Duration: 4 hours
Lecturer: Dragana Lakic

2. Pharmacoeconomic Modeling: Approval, Training, and Annual Review of a Drug's Price.
Duration: 4 hours
Lecturer: Dragana Lakic

3. Added therapeutic value and drug positioning. Pharmacy and Therapeutics Committee.
Duration: 4 hours
Lecturer: Dragana Lakic and Pedro Barata

Total: 12 teaching hours / 25 total hours • 1 ECTS

Skills to Acquire:
• To understand the process and methodology for evaluating health technologies.
• To know and be able to interpret the main methodologies for evaluating health technologies.

Course Content:

1. Concept of Medical Device (MD) and its regulatory definition;
Classification of medical devices and their boundaries with other legislation; The Notified Body and the Competent Authority; Post-marketing surveillance system.
Duration: 4 hours
Lecturer: Pedro Barata and Rita Oliveira

2. Impact of essential requirements and various harmonized standards on Quality Systems. Harmonized Standards applied to the manufacture and marketing of medical devices. Transition to the New Medical Device Regulation (MDR). CER (Clinical Evaluation Report).
Duration: 4 hours
Lecturer: Monica Povo and Pedro Barata

3. Quality management system. Risk management system.
Good Manufacturing Practices. Good Distribution Practices.
Duration: 4 hours
Lecturer: Manuel João Oliveira and Pedro Barata

Total: 12 teaching hours / 25 total hours • 1 ECTS

Skills to Acquire:
• Understanding the circuitry of medical devices
• To know and be able to interpret the documentation supporting the introduction of medical devices to the market.
• Understanding the circuit and methodology for evaluating medical devices

Course Content:

1. Regulatory framework. Notification via the European Electronic Portal.
Product Information Registration. Cosmetic Safety Assessment.
Labeling.
Duration: 4 hours
Teacher: Rita Oliveira

2. Claimed effects of cosmetics. Cosmetovigilance..
Duration: 2 hours
Teacher: Rita Oliveira

3. Regulatory framework for food supplements.
European Food Safety Authority.
Notification regarding dietary supplements.
Importation of food supplements.
Claimed effects. Borderline products.
Duration: 2 hours
Lecturer: Carla Martins Lopes


Total: 8 teaching hours / 20 total hours • 0.8 ECTS

Skills to Acquire:
• Understanding the supply chain for Cosmetics, Personal Hygiene Products, and Food Supplements
• To understand the process of introducing cosmetic and personal hygiene products and food supplements to the market.

Course Content:

1. Fundamentals of ethics. Law of clinical research.
Ethics committees (CEIC; CES) ORBEA and DGAV.
Duration: 4 hours
Lecturers: Susana Teixeira and Pedro Barata

2. Clinical study design.
Clinical Trials – Regulation.
Good clinical practices ICH.
Protocol. Informed Consent. Investigator Brochure.
Duration: 4 hours
Teachers: Carla Martins Lopes

3. Experimental drug. Experimental Drug Circuit
Statistics and epidemiology applied to the clinical development of medicines.
Duration: 4 hours
Teachers: Pedro Barata

4. Statistics and epidemiology applied to the clinical development of medicines.
Duration: 2 hours
Lecturers: Pedro Barata and Fernando Mota


Total: 12 teaching hours / 25 total hours • 1 ECTS

Skills to acquire:
• Understanding the circuit of the experimental drug
• To acquire fundamental knowledge related to clinical research and clinical development of medicines and medical devices.

Students will be required to submit a final paper/report on one of the topics taught during the course.
Lecturers: Pedro Barata, Rita Oliveira and Carla Martins Lopes

Total: 4 teaching hours / 4 total hours • 0.2 ECTS

Coordination & Contacts

Professor Doctor Pedro Barata
Professor Doctor Rita Oliveira
Professor Doctor Carla Martins Lopes

Fernando Pessoa Academy
9th of April Square, 349
4249-004 Porto
T. +351 22 507 1300
academia@fundacaofernandopessoa.pt

Request information about the course:

Faculty

Pedro Barata, MD, PharmD, PhD
Faculty of Health Sciences, Fernando Pessoa University

Eurico Castro Alves, MD
University of Porto

Rita Oliveira, PharmD, PhD
Faculty of Health Sciences, Fernando Pessoa University

Carla Martins Lopes , PharmD, PhD
Faculty of Health Sciences, Fernando Pessoa University

Dragana Lakic, PhD
University of Lisbon

Gilberto Alves, PharmD, PhD
University of Beira Interior

Felix Carvalho, PharmD, PhD
University of Porto

Ana Povo, MD, PhD
University of Porto

Fernando Mota, PharmD, MSc, MBA
Global Head Clinical Trials – Novartis

Monica Povo, Lic
Pharmaceutical Consultant

Manuel João Oliveira, Lic
University of Lisbon

Hélder Mota Filipe, PhD
University of Lisbon

Gilberto Alves, PhD
University of Beira Interior

Domingos Ferreira, PhD
University of Porto

APPLICATION REQUIREMENTS

Applications are open: To be defined
Application Results: To be defined
Exclusively online applications: http://inforestudante.ufp.pt Postgraduate studies

Required documents:
• Diploma or certificate proving the academic degree
• Curriculum vitae.

School Dates & Fees

New edition:
Start: To be defined

Module 1 – Medicines and Marketing Authorization
Module 2 – Pharmacoeconomics and Health Technology Assessment
Module 3 – Medical Devices
Module 4 – Cosmetic and Personal Hygiene Products and Food Supplements
Module 5 – Research and Clinical Trials
Assessment

* The course will only run if a minimum number of students attends.


Fees 1 / 2

Application fee: €50
Bribe (immediate payment):
• General: €1200
• UFP Alumni: €1000

Tuition fee (monthly / 4 installments):
• General admission: €300
• UFP Alumni: €250

Tuition fee per module2:
Module 1 – Medicines and Marketing Authorization (€240)
Module 2 – Pharmacoeconomics and Health Technology Assessment (€240)
Module 3 – Medical Devices (€240)
Module 4 – Cosmetic and Personal Hygiene Products and Food Supplements (€160)
Module 5 – Research and Clinical Trials (€240)

1 There are no refunds for payments made.
2 Choosing modules does not allow you to attend the entire course and does not confer a "Postgraduate Certificate".