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, EU Medicines Agency, and Irish Health Products Regulatory Authority regulatory systems is essential for all those working within the industry. The module also provides an overview of the Regulatory Department of the (bio)pharmaceutical and life sciences sector as the interface with the legal and regulatory authorities, and its role in drug development, approval, and marketing. It also cover the contents of the Regulatory Dossier, and the ICH Guidelines for Quality, Safety, and Efficacy.
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.
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. Regulation (EC) No 726/2004, Regulation (EU) No 1235/2010, Regulation (EC) No 1394/2007
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
ICH Guidelines for Safety, Efficacy and Quality
The role of the Irish Health Products Regulatory Authority HPRA
The function of the Pharmaceutical Regulatory Affairs department at the interface of Regulatory agencies and the pharmaceutical industry in the development, approval and marketing, and post-marketing of medicines
The contents of the Regulatory dossier file.
Lectures, case studies, industry speakers, site visits
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |