This module aims to provide the student with details of the regulatory and GMP guidelines of the pharmaceutical industry
Regulatory Standards and guidelines:
EU regulations; Irish regulations; Regulatory Bodies (including responsibilities and structure of HPRA, EMEA and FDA); International Council for Harmonisation (ICH); Guidelines (ICH and EMEA working parties)
Marketing Authorisations:
Legal basis of applications within EU; Procedures for making a Marketing Authorisation Application: National, Mutual Recognition, Decentralised and Centralised; Common Technical Document (CTD): Modules 1-4; Clinical Trial applications and Module 5 of CTD; Maintenance of applications: Variations and renewals; Summary of Product Characteristics; Labels and leaflet requirements; Generic medicines; Regulatory Compliance; Classification of Medicinal Product; Pharmacovigilance
Use of regulatory case studies where possible
TeGenero case - TGN1412 antibody drug; Transmissible retroviral and Spongiform Disease, impact on the industry., Regulatory cases studies from the Irish and US pharmaceutical sector including the Barr case
Good manufacturing Practices
The Rules Governing Medicinal Products in the European Union EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use; GMP/c-GMP; Introduction to GMP, Hygiene, Dress Code, GMP Goals, SOPs, Records and logbooks, Out Of Specification results investigations, deviations, stability studies, calibration, audits and inspections; Auditing, CAPA - Root Cause Analysis; Practical Clean room training
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |