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Module Overview

cGMP 3 (Regulatory Affairs and Validation)

This module aims to provide the student with a detailed understanding of the requirements of the GMPs, MA’s, MA compliance and clinical trails.

Module Code

GMPR H3041

ECTS Credits

5

*Curricular information is subject to change

Good Manufacturing Practice.

EC GMP Guidelines – Volume 4 of ‘The rules governing medicinal products in the European Union’.CFR 210 / 211.ICH ---- Q7A, Q8, Q9, Q10. WHOCase studies in GMP inspections.Auditing – techniques and case studies.21 CFR Part 11, GAMP

Regulatory Affairs:

European Union Institutions, Definition of Medicinal Products.Labelling and Packaging Requirements.Advertising, Distribution and Supply, Good Distribution PracticeVeterinary Medicines, Residues.Preparation of Marketing Authorization Applications and associated variations and renewals.Comparison of EU and FDA policy and procedures.

Clinical trials

Preclinical Studies, Phases of clinical trails. Pharmacovigilance.Investigational medicinal products. (IMP and INDA)

Module Content & Assessment
Assessment Breakdown %
Formal Examination70