Module Overview

Pharmaceutical Industry Regulatory Affairs

The Pharmaceutical industry must work within a regulatory /legal framework. Therefore it is important that the student understands the judicial and legislative system as well as legal procedure and administration directly relating to their role in the Pharmaceutical industry. 

Pharmaceutical professionals have a civil responsibility thus liability to those whom they serve along with a possible criminal liability under national and EU statute. In addition knowledge of the US FDA regulatory system is essential for all those working within the industry.


Module Code

TFQM 2002

ECTS Credits


*Curricular information is subject to change

Introduction- The Pharmaceutical Industry & the Law, the principles & functions of the Law and its basis in 
natural justice.

The National Legislative Process, The Constitution, Dail & Seanad, the influence of the citizen. Interpretation 
of Law. 

Court Structures- Courts of first instance and appeal – District Court, Circuit Court, High Court, Supreme 

Court, and Special Criminal Court. Function of the Legal Professions and Law officers. 

The Legal system - Distinction between Civil proceedings and Criminal proceedings- the different standards 
and burdens of proof. 

Civil Law – Introduction to Tort, Contract, Constitutional & Company Law. Remedies available.

Law of Tort – Professional Negligence, Statutory Duty, Product liability, Occupiers Liability, Defamation, 
Nuisance (noise & smell), Malicious Prosecution, Vicarious Liability, Damages, Defences, Limitations
Introduction to European Law- the European Union Institutions, the European Legislative process and the 
influence of the citizen, types of European Union Law (Primary and secondary). 

Introduction to the European Union Pharmaceutical Regulatory Process: The European Medicines Agency. 
Eudralex, The Community Register. European Case law. Interpretation of European Law
Introduction to the US Pharmaceutical Regulatory Process: The Code of Federal Regulations Title 21. The
Federal Food, Drug, and Cosmetic Act of 1938. The Kefauver-Harris Amendments of 1962.

The Medical Device Amendments of 1976. The Food and Drug Administration Amendments Act of 2007


Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100