94286 - Food and Drugs Regulations

Learning outcomes

Students will gain a comprehensive understanding of food and drug regulations, with a focus on the frameworks governing chemical management in these sectors. This course unit integrates regulations on general chemical substances, pharmaceuticals, and food products, offering insights into compliance and innovation in these critical areas. The student is expected to be able to: 1. Understand the REACH and CLP regulations in the EU, focusing on classification, labelling, and management of hazardous substances, and their implications for health and safety; 2 .Analyze the regulatory frameworks guiding drug development and pharmaceuticals, including the role of regulatory authorities, clinical development, and access to medicines and devices; 3. Evaluate food regulations, with attention to safety, labelling, and compliance requirements, ensuring the protection of public health and fostering innovation in the food industry.

Course contents

This CU is composed of three modules:

(1) REACH and CLP

The course provides an overview of the remit of REACH and the increased responsibility it places on industry to manage chemical risks. The course introduces to the aims and core principles of REACH: protection of human health and the environment; enhance EU chemical industry competitiveness; and the promotion of alternative methods of dangerous substance assessment.

The Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008, is another column of the Chemical Management Program in the European Union and provides the rules for the classification of hazardous compounds, their labelling, and Safety Data Sheet (SDS) information. The course provides an overview of this important regulation.

(2) Pharmaceutical Regulations

Therapeutic innovation. Role of regulations and regulatory authorities. Nonclinical development. Clinical development. Role of ethics. Regulatory process for medicines authorization. Medicines vs medical devices. Regulations on medical devices. Regulation of access. Health technology assessment (HTA). Development of generics and biosimilars and its role on access to medicines.

(3) Food Regulations

This module provides a comprehensive overview of the chemicals in food regulation

Readings/Bibliography

Slides will be available for students.

Teaching methods

The Course Unit is divided in three modules. Each module is organized in theoretical classes where main concepts are explained, as well as tutorial classes with discussion of case-study examples.

Assessment methods

Each module learning is evaluated independently, exploiting: i) written tests; ii) oral presentations or interviews; iii) written assignments or combinations of them. The Course Unit grade will be the arithmetic mean of grades from the three modules. ChIRS grades scale goes from 1 to 100, pass grade is
40, and will be translated into ECTS and different University scales. Criteria: knowledge on a very limited number of topics covered in the course and analytical ability that emerges only with the help of the instructor, using generally correct language → 40-45;
Knowledge on a limited number of topics covered in the course and independent analytical ability only on purely executive
issues, using correct language → 45-60;
Knowledge on a large number of topics covered in the course, ability to make independent critical analysis choices, mastery
of specific terminology → 60-80;
Essentially comprehensive knowledge on the topics covered in the course, ability to make independent critical analysis and
connection choices, full mastery of specific terminology, and ability for argumentation and self-reflection → 80-100.

Teaching tools

Lectures slides and notes will be available on the course moodle https://emmcchir-learning.ualg.pt

Office hours

See the website of Rafael Llorach Asuncion

See the website of

See the website of Helder Dias Mota Filipe