PHA-30051 - Module Specification
School of Pharmacy and Bioengineering
Faculty of Medicine & Health Sciences

Programme/Approved Electives for 2024/25

Available as a Free Standing Elective

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2024/25

The module is underpinned by the national and international regulations that frame the manufacture, distribution and use of cosmetic and associated products, including ¿borderline¿ areas where the definitions of such product may differ or overlap (with, for example, over-the-counter medicines or personal care products) (e.g. ICH = International Council of Harmonisation, OECD = Organisation for Economical Co-operation and Development, GMP = Good Manufacturing Practice, GLP = Good Laboratory Practice).
Understanding experimental data generation that underpins safety and pharmacology data is key to an understanding of product quality and safety. Product safety is therefore discussed in terms of the underlying pharmacological and toxicological sciences and their translation into legislation and regulatory processes. This module will discuss the above regulations and amendments in the context of product and ingredient safety, safety testing including clinical evaluation, and how cosmetic claims may be understood in the context of product safety (e.g. claims for ¿mildness¿.
Woven throughout the module is development of essential team-working and leadership skills: group-based tasks within the laboratory classes and practical skills workshops provide students with a forum to demonstrate their potential to work in and lead interdisciplinary teams.

The main focus of this module is on decision-making with regard to the safety of cosmetic formulations. All cosmetic products placed on the market of the United Kingdom (including Northern Ireland) intended for sale or to be given away for free in the course of a commercial activity must comply with the law, specifically Schedule 34 of the Product Safety and Metrology Statutory Instrument for Cosmetics in Great Britain and, for products marketed in Northern Ireland, Regulation EC1223/2009 of the European Parliament and Council on cosmetic products marketed in Northern Ireland. The role of the Office for Product Safety and Standards (OPSS) in the marketing of cosmetics will be explained. More broadly, and to emphasise the international context of this programme, the EU regulations (notably 1223/2009 and subsequent amendments) will be discussed.
Embedded in these regulations is product safety. This module will discuss the above regulations and amendments in the context of product and ingredient safety, safety testing including clinical evaluation, and cosmetic claims particularly for efficacy.

Intended Learning Outcomes

appreciate the framework for cosmetic product approval in appropriate major territories (notably the UK and EU) and how these are underpinned by product safety;: 1,2
critically evaluate the safety of different routes of product administration, notably topical, oral and pulmonary;: 2
explain and interpret the major regulatory considerations for product safety on a product-by-product or ingredient-by-ingredient basis. This includes understanding the historical role of animals and animal products in safety testing, with reference to current regulations and legislation and the implications for current testing;: 1,2
explain the common techniques used in the analysis of biological data to arrive at safe and appropriate ingredient selection for a consumer;: 2
appreciate the basis of in vitro safety testing for ensuring safety of cosmetic products (e.g. genotox (Ames test), dermal sensitivity, dermal absorption);: 2
appreciate the differences between regulatory toxicology, genetic toxicology, and reproductive / developmental toxicology;: 2
appreciate the nature of laboratory and clinical evaluation in product development;: 2
interpret safety pharmacology data and to interpret it in the context of current regulations and legislation;: 1,2
interpret clinical toxicity data in order to determine the safety of products and ingredients;: 1,2
demonstrate competence in pharmacological and toxicology calculations related to quality assurance and quality systems in cosmetic formulation development.: 1,2

Study hours

50 hours teaching
100 hours self-study
Large- and small-group teaching sessions: 25 hours
Skills-based practical work: 25 hours
Directed private study, revision and assessment: 98 hours
Exam: 2 hours

School Rules

None

Description of Module Assessment