Regulatory Affairs (PHAY0070)

Key information

Faculty: Faculty of Life Sciences
Teaching department: School of Pharmacy
Credit value: 30

Restrictions: This module is only available to students taking the PG Dip in Pharmaceutical Quality and Regulation.
Timetable

Alternative credit options

There are no alternative credit options available for this module.

Description

Manufacture and supply of pharmaceutical and biotechnological products is highly regulated within the European Union (EU) and European Economic Area (EEA). One of the legal duties of the Qualified Person is to ensure that products manufactured, either within the EU or at a contract manufacturing organisation (CMO) outside of the EU, comply with all EU regulatory obligations before any product is released for sale or supply, including investigational Medicinal Products (IMPs) used in clinical trials.

Module deliveries for 2024/25 academic year

Intended teaching term: Calendar Year 听听听 Postgraduate (FHEQ Level 7)

Teaching and assessment

Mode of study: In person
Methods of assessment: 25% Coursework

75% Exam
Mark scheme: Numeric Marks

Other information

Number of students on module in previous year: 12
Module leader: Professor Kevin Taylor
Who to contact for more information: sop.pgt@ucl.ac.uk

Last updated

This module description was last updated on 8th April 2024.

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Important information

The catalogue has been updated with key information about the modules that will run during the 2024/25 academic session. Current and prospective students can browse through the catalogue to consider possible module choices for the coming year.

Please note,听information in the catalogue is听subject to change as teaching and assessment arrangements for 2024/25 may need to be adjusted in line with the University's Feedback and Assessment principles and operating model.

Centrally managed exam durations will be provided on students' individual exam timetables. Arrangements for locally managed exams and in-class activity will be confirmed by the teaching department for the module.

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