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Drug Regulatory Affairs (Module)

Module description

This module explores the principles that underpin drug regulation in the UK and worldwide. Over five days, we will consider the regulatory requirements for special patient populations, commercial issues from product life cycle development through to marketing, pharmacovigilance, and the handling of off label and unlicensed medicines.

Key topics include: European regulatory procedures, ethics committees, adverse drug reaction reporting, regulatory requirements in special populations (eg, children, the elderly), advertising, internet sales, medical aspects of the Marketing Authorisation, bioequivalence and generics, special licensing issues (such as for biologicals, devices, herbal and homoeopathic medicines), and pharmacovigilance (pre- and post-marketing)

You will take part in a series of workshops to learn about practical aspects of Clinical Trial Authorisations, preparation of Summaries of Product Characteristics and Patient information leaflets, risk minimisation, and reclassification of the legal status of medicines.

Staff information

Not applicable

Teaching pattern

Not applicable

Module assessment - more information

Not applicable

Key information

Module code 7BBP0007

Credit level 7

Assessment

Credit value

Semester

Study abroad module No