Upon completion of the course, students will be able to:
§ Describe and explain the key principles of Quality Assurance (QA) and Quality Management Systems (QMS), and their role in ensuring product quality, patient safety, and regulatory compliance;
§ Apply QA principles and Good Practice requirements (GLP, GCP and GMP) to preclinical studies, clinical trials, laboratory activities, pharmaceutical development, and manufacturing operations;
§ Identify and interpret the main national and international regulations, guidelines, and quality standards applicable to biomedical and pharmaceutical activities;
§ Apply a risk-based approach to analyse quality-related issues and propose appropriate solutions in practical case studies;
§ Understand and explain the principles, objectives and key processes of audits and regulatory inspections, including internal audits, supplier audits, and computerized system audits;
§ Relate QA principles to their implementation in major biomedical and pharmaceutical domains, including biopharmaceutical development and manufacturing, clinical research, biobanks, pharmaceutical development and quality control laboratories.
The aim of this course is to introduce students to the principles of Quality Assurance (QA) and Quality Management Systems (QMS) applicable to biomedical and pharmaceutical activities, with particular emphasis on Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and the regulatory frameworks governing clinical research, medicinal product development and pharmaceutical manufacturing.
It further aims to provide students with a foundational understanding of the role of quality systems in supporting patient safety, product quality, data integrity and regulatory compliance throughout the development, clinical evaluation and manufacture of medicinal products. The course also seeks to develop students’ ability to critically reflect on quality-related issues encountered in clinical trials, pharmaceutical manufacturing and quality control environments.
§ Historical overview of the quality management system concept and its relevance in (pre-)clinical studies and medicinal product development.
§ Key Concepts of a Quality Management System:
§ Change Management (change control processes),
§ Deviation Management and Corrective and Preventive Actions (CAPA),
§ Quality Risk Management (QRM) and risk analysis tools,
§ Quality by Design (QbD) principles,
§ Documentation management, good documentation practices, and data integrity,
§ Supplier management, outsourced activities, and contractual aspects,
§ Complaint handling and management,
§ Internal audit activities,
§ Calibration, qualification and validation of equipment and systems,
§ Regulatory Environment: overview of the regulatory framework governing quality systems in regulated environments.
§ Specific aspects and practical considerations in the following domains:
ü Good Clinical Practice (GCP)
ü Good Manufacturing Practice (GMP) including Quality Control activities and Good Distribution Practice (GDP)
ü Good Laboratory Practice (GLP) / Good Clinical Laboratory Practice (GCLP)
§ Practical case studies
Course Synopsis
§ Quality Systems in GxP Regulated Environments
Foundations, regulatory references and strategic architecture of QMS.
§ Quality Governance and Operational Control
Deviation, CAPA, change control, management review and Quality Unit oversight.
§ Documentation, Traceability and Data Integrity
Document lifecycle, GxP records and ALCOA+ principles.
§ Organisation, Competence and Training
Key responsibilities, organisational structure and qualification of personnel.
§ Premises, Cleanrooms and Controlled Flows
Facility design, zoning, cleanliness grades and contamination control principles.
§ Supply Chain and Quality System Surveillance
Supplier qualification, distribution controls, complaints, recalls and self-inspection.
§ Qualification, Validation and Lifecycle Control
Introduction to equipment qualification, system validation and cleaning validation.
§ Quality Control and Analytical Governance
QC laboratory organisation, analytical lifecycle, specifications, OOS investigations and data integrity.
§ QMS in Biomedical Research and Clinical Development
Research quality systems, reproducibility, QA/QC tools and application to clinical trials.
§ GCP, Clinical Data Quality and Oversight
Clinical trial conduct, clinical data governance, clinical data flow, computerised system validation and monitoring.
§ Advanced GCP, GCLP and GLP Frameworks
ICH E6(R3), Quality by Design, risk-based management and GCP audit/inspection.
Please note that the course content may be subject to minor adjustments or adaptations, where relevant.
Students will be provided with the presentation slides used during the oral lectures. The teaching approach will place emphasis on students’ understanding and on their ability to establish links between theoretical concepts and their practical implications, in order to facilitate effective integration and application.
Oral examination
§ European Commission, Directorate-General for Health and Food Safety (DG SANTE). EudraLex Volume 4: Good Manufacturing Practice Guidelines. Principal European reference for Good Manufacturing Practice requirements applicable to medicinal products, including GMP chapters, annexes and guidance documents used by manufacturers, Qualified Persons, regulators and GMP inspectors throughout the European Union. Available at: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en (accessed September 2026).
§ European Commission, Directorate-General for Health and Food Safety (DG SANTE). EudraLex Volume 10: Clinical Trials Guidelines. European Union reference framework for the conduct and oversight of clinical trials of medicinal products for human use, including guidance supporting the implementation of Regulation (EU) No 536/2014. Available at: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en (accessed September 2026).
§ European Medicines Agency (EMA). Scientific Guidelines. Collection of regulatory and scientific guidance supporting the development, manufacture, evaluation, approval and lifecycle management of medicinal products in the European Union. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines (accessed September 2026).
§ European Medicines Agency (EMA). Clinical Trials Regulation (EU) No 536/2014. Regulatory framework governing clinical trials in the European Union. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines (accessed September 2026).
§ European Medicines Agency (EMA). Scientific Guidelines. Comprehensive collection of EMA guidelines covering clinical development, biostatistics, paediatrics, biosimilars, oncology and advanced therapies. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Training Programme for Q8/Q9/Q10. Training material describing the integration of ICH Q8, ICH Q9(R1) and ICH Q10 within a lifecycle approach to pharmaceutical quality. Available at: https://ich.org/page/training-programme-q8q9q10-0 (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Quality Guidelines. Collection of internationally harmonised guidelines covering pharmaceutical development, quality risk management, pharmaceutical quality systems, active pharmaceutical ingredients, analytical procedures and lifecycle management of medicinal products. Available at: https://www.ich.org/page/quality-guidelines (accessed September 2026).
§ World Health Organization (WHO). WHO Good Practices for Pharmaceutical Quality Control Laboratories. Annex 1, WHO Technical Report Series No. 957, 2010. International reference describing quality management systems, documentation, personnel, premises, equipment qualification, reagents, reference standards, analytical procedures, validation, testing, reporting and retained samples for pharmaceutical quality control laboratories. Available at: https://www.who.int/publications/m/item/trs957-annex1 (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). E6(R3): Good Clinical Practice. International standard defining ethical and scientific requirements for the design, conduct, recording and reporting of clinical trials. Available at: https://www.ich.org/page/efficacy-guidelines (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). E8(R1): General Considerations for Clinical Studies. Foundational guideline describing quality by design and proportionate risk management principles in clinical development. Available at: https://www.ich.org/page/efficacy-guidelines (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). E9: Statistical Principles for Clinical Trials. Guidance on statistical design, conduct, analysis and interpretation of clinical studies. Available at: https://www.ich.org/page/efficacy-guidelines (accessed September 2026).
§ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). M4: Common Technical Document. Harmonised format for marketing authorisation applications. Available at: https://www.ich.org/page/ctd (accessed September 2026).
§ Organisation for Economic Co-operation and Development (OECD). OECD Principles on Good Laboratory Practice. OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1, revised 1997. International reference defining the organisational process and quality system under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived for regulatory purposes. Available at: https://www.oecd.org/en/publications/oecd-principles-on-good-laboratory-practice_9789264078536-en.html (accessed September 2026).
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Pharmacy | Finalité approfondie | 1 | 3 | Yes |
| Master in Biomedical Sciences | Standard | 1 | 3 | No |
| Master in Pharmacy | Finalité spécialisée | 1 | 3 | Yes |
| Master in Biochemistry and Molecular and Cell Biology | Finalité approfondie | 1 | 3 | Yes |
| Master in Biomedical Sciences | Filière en gestion de la recherche clinique | 1 | 3 | No |
| Master in Biochemistry and Molecular and Cell Biology | Finalité spécialisée | 1 | 3 | Yes |
| Master in Biomedical Sciences | Filière en recherche fondamentale et préclinique | 1 | 3 | Yes |
| Master in Chemistry | Finalité spécialisée en chimie en entreprise | 2 | 4 | No |