97496 - Regulation and Nanotech

Learning outcomes

At the end of the course the student will be aware of chemical regulation and in particular with the challenging issue of regulation of nanomaterials. the student will become familiar with the European REACH (Registration, Evaluation and Authorization of Chemicals). He/she will also know criticity of regulations related to nanomaterials and nanotechnology that represent a rapidly growing innovation topic. Applicationof nanothechnology in the medical and pharmaceutical field is strongly increasing. For this reason, the student will put a special focus on pharmaceutical regulations. The student is expecte do be able to: 1. comply with REACH regulation and with CLP labelling; 2. manage issues relate to nanomaterials regulation; 3. manage the issues related to the use of nanomaterials in the pharmaceutical and related fields.

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) Nanomaterials and Nanotechnologies Regulations

The module will:

· introduce principles of nanoparticles synthesis characterization and application

· introduce principles of nanotoxicology

· Introduce frameworks of risk assessment/management/ governmental legislations

· Show how safe and sustainable by design nanomanufacturing can be implemented

Readings/Bibliography

Slides will be available for students.

Additional bibliography: ·

• “Managing Risk in Nanotechnology - Topics in Governance, Assurance and Transfer”, Springer Publishing, Editor (s) Finbarr Murphy, Eamonn M. McAlea, Martin Mullins 2016. ·
• “Engineered Nanoparticles: Structure, Properties and Mechanisms of Toxicity”, 1st Edition, by Ashok K. Singh, by Academic Press, 2015.
• “Nanotoxicology: Progress toward Nanomedicine”, 2nd Edition, March 3, 2014 by CRC Press Content, Editor(s): Nancy A. Monteiro-Riviere; C. Lang Tran, 2014.
• S. Gottardo et al. Towards safe and sustainable innovation in nanotechnology: State-of-play for smart nanomaterials, nanoImpact 21 (20219100297)

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 is assessed through a written assignment, or group assignment, or Individual report of a given problem related to the module content, or power point presentation of an assigned topic, including a report on literature research.

The Course Unit grade will be the arithmetic mean of grades from the three modules.

Office hours

See the website of Anna Luisa Costa

See the website of Carlos Molina Herrero

See the website of Helder Dias Mota Filipe