Cours spécifiques à la finalité spécialisée en conception et développement du médicament - bioanalyse (Q1)

Qualité en industrie pharmaceutique et affaires réglementaires

Module 1

Introduction to Quality Assurance Concept.

Presentation of norms and guidelines linked to pharmaceutical industry.

Introduction to audit.

Modules 2 and 3

Introduction to the concepts of risk management and data integrity

Presentation of strategies for managing these two concepts

Presentation and use of tools for analyzing a specific situation related to the management of quality and associated data integrity risks

Module 4

In this final section, we will consider the role of the pharmacist in the field of regulatory affairs in the industry. This field covers the entire life cycle of a drug, from its launch on the market to its use in the healthcare system, including its possible coverage by health insurance.

The duties and obligations of the "industry" pharmacist will be discussed in relation to the regulatory obligations relating to the Marketing Authorization (MA) of the drug and the requirements of Good Manufacturing Practices (GMP). Particular attention will be given to Advanced Therapy Medicinal Products (ATMPs).

Regulation (EU) 2021/2282, which governs the assessment of health technologies as defined in Directive 2011/24/EU, will also be discussed. One of the objectives of this regulation is to establish common rules and methods for the joint clinical assessment of health technologies, including medicines, in Europe. These developments will be used to make decisions on the reimbursement of medicines by health insurance schemes.

Concepts spécifiques en biologie clinique

Some topics will be covered by all instructors to ensure exposure to a wide range of cases.

Marine Deville:
The toxicology module will focus on practical aspects and real-world applications encountered in a toxicology laboratory, emphasizing its specific features in terms of:

• Sample types (advantages of alternative matrices such as saliva and hair);
• Instrumentation (predominance of chromatographic methods);
• Accreditation (coexistence of three different standards).

• Describe the organization of clinical laboratories in Belgium, distinguishing between private, hospital-based, and university-affiliated structures, along with their respective missions.
• Understand the specific functioning of a hospital-university clinical chemistry laboratory, including its roles in patient care, education, and research.
• Identify and explain the different types of analyses performed in clinical chemistry, including:
  * Routine tests
  * Specific clinical studies
  * Development and validation of new analytical methods
• Grasp the critical importance of the pre-analytical phase, including sample quality, transport, storage, and preparation, to ensure reliable results.
• Justify the choice of an analytical method based on clinical context, considering analytical principles, potential interferences, and quality requirements.
• Analyze and interpret real cases highlighting analytical or pre-analytical issues, such as biological or chemical interferences that may distort results.
• Develop a critical approach to laboratory results, integrating concepts of biological variability, quality control, and clinical relevance.

• Describe the funding mechanisms for clinical biology laboratories in Belgium, distinguishing between outpatient and hospital-based structures.
• Understand the specific functioning of a hospital-university laboratory, including the management of outsourced analyses and tests under Article 24 bis/33 ter.
• Identify and explain the different types of anemia based on clinical cases, including:
  * Iron-deficiency anemia
  * Macrocytic anemia
  * Mixed anemia
• Analyze and interpret real cases highlighting analytical or pre-analytical issues, particularly biological interferences that may distort results.
• Develop a critical approach to laboratory results, integrating concepts of biological variability, quality control, and clinical relevance.

Compléments de pharmacocinétique

In this course, students will work with real clinical data to apply the pharmacokinetic concepts covered in the core curriculum. Bioequivalence studies will also be discussed.This course also covers regulatory aspects related to pharmacokinetics, including EMA requirements for the pharmacokinetic analysis of new drugs. Students will gain a deeper understanding of how pharmacokinetics is considered in drug regulation and how pharmacokinetic data can be used to support the regulatory approval of new drugs.

Radiopharmacie

This course serves as an introduction to radiopharmacy, providing students with a structured overview of the key concepts of the discipline. It covers the fundamentals of the design, preparation, and use of radiopharmaceuticals in both diagnosis and therapy, as well as the core principles of radiation safety. Particular emphasis is placed on the rapid development of the field worldwide and on Belgium's outstanding contribution to this area. The course is designed to prepare students for further specialization, particularly through a certificate in radiopharmacy.

Qualité en industrie pharmaceutique et affaires réglementaires

The objective of this module is to provide key insights into quality and regulatory affairs in the pharmaceutical industry.

Upon completion of this course, editors will be able to:

• Master the fundamentals of quality assurance in the pharmaceutical sector, including standards and audits;
• Understand and apply the principles of risk management and data integrity, which are essential to pharmaceutical quality;
• Use analytical tools to assess real-life situations related to risk management and data compliance.
• Identify the role of the "industry" pharmacist in the field of quality and regulatory affairs throughout the drug life cycle;
• Integrate European regulatory requirements, including GMP, MA, and Regulation (EU) 2021/2282 on health technology assessment.

Concepts spécifiques en biologie clinique

Develop a critical approach to laboratory results by integrating concepts of biological variability, quality control, and clinical relevance.

Compléments de pharmacocinétique

• Apply the pharmacokinetic models covered in the core curriculum to the analysis of real clinical data.
• Interpret pharmacokinetic parameters.
• Compare different analytical approaches (non-compartmental, compartmental).
• Use data sets from clinical trials to perform relevant pharmacokinetic calculations.
• Explain the scientific and methodological principles of bioequivalence studies.
• Implement statistical analyses to evaluate bioequivalence between formulations.

Radiopharmacie

By the end of this course, students will be able to:
1. Explain the fundamental principles of radiopharmacy and place the discipline within the broader context of pharmaceutical sciences.
2. Describe the main steps involved in the design, preparation, and use of radiopharmaceuticals for diagnosis and therapy.
3. Identify key radiation safety concepts relevant to the handling of radioactive substances in pharmacy.

Qualité en industrie pharmaceutique et affaires réglementaires

None

Concepts spécifiques en biologie clinique

Analyze and interpret real-life cases that highlight analytical or pre-analytical issues, particularly biological interferences that may distort results.
Develop a critical approach to laboratory results by integrating concepts of biological variability, quality control, and clinical relevance.

Compléments de pharmacocinétique

General pharmacokinetics course

Radiopharmacie

Organic & Medicinal Chemistry

Qualité en industrie pharmaceutique et affaires réglementaires

Lectures are given in an ex-cathedra style, alternating with discussions.

Concepts spécifiques en biologie clinique

Courses in face to face

Lectures (ex-cathedra), experience sharing, and clinical case discussions

Compléments de pharmacocinétique

For teaching methods, see the section below.

Radiopharmacie

Course given by 2 lecturers & requiring active student participation.

Qualité en industrie pharmaceutique et affaires réglementaires

Face-to-face course

Concepts spécifiques en biologie clinique

Face-to-face course

Compléments de pharmacocinétique

Face-to-face course


Further information:

Classes are held in person.
Exercise sessions will be organized to learn how to handle the values obtained in clinical studies.

Radiopharmacie

Face-to-face course

Qualité en industrie pharmaceutique et affaires réglementaires

Platform(s) used for course materials:
- Microsoft Teams


Further information:

The materials corresponding to the presentation used during the lectures will be made available in PowerPoint or PDF format.

Concepts spécifiques en biologie clinique

Platform(s) used for course materials:
- eCampus

Radiopharmacie

Platform(s) used for course materials:
- eCampus


Further information:

The course materials will be made available online progressively.

Qualité en industrie pharmaceutique et affaires réglementaires

Exam(s) in session

Any session

- In-person

written exam

Concepts spécifiques en biologie clinique

Exam(s) in session

Any session

- In-person

written exam ( multiple-choice questionnaire, open-ended questions )

Compléments de pharmacocinétique

Exam(s) in session

Any session

- In-person

written exam ( multiple-choice questionnaire, open-ended questions )


Further information:

In-person exam in the form of a written multiple-choice assessment and/or open-ended questions

Radiopharmacie

Exam(s) in session

Any session

- In-person

written exam ( multiple-choice questionnaire, open-ended questions )

Qualité en industrie pharmaceutique et affaires réglementaires

Not applicable.

Radiopharmacie

Information on internship opportunities within the laboratory will be provided to interested students.

Qualité en industrie pharmaceutique et affaires réglementaires

None.

Qualité en industrie pharmaceutique et affaires réglementaires

Eric Ziemons, Chargé de cours
Service de Chimie Analytique Pharmaceutique, Département de Pharmacie, CHU Bât. B36, Quartier Hôpital,avenue Hippocrate 15, 4000 Liège 1
Tel. : 04/366.43.16
e-mail: eziemons@uliege.be 

Secrétariat
Murielle Bihain, Service de Chimie Analytique Pharmaceutique, Département de Pharmacie, CHU Bât. B36, Quartier Hôpital,avenue Hippocrate 15, 4000 Liège 1
Tél : 04/366.43.16
e-mail: mbihain@uliege.be 

Concepts spécifiques en biologie clinique

c.legoff@chuliege.be

Compléments de pharmacocinétique

Prof. Géraldine PIEL, Laboratoire de Technologie Pharmaceutique et Biopharmacie Tél : 04/3664308 geraldine.piel@uliege.be

Prof. Raphaël DENOOZ Service de Toxicologie clinique et médicolégale CHU B35 Sart-Tilman, B4000 Liège Tél. 04/3667683 ou 04/3668816 Fax 04/3668889 e-mail : Raphael.denooz@chuliege.be

Radiopharmacie

Academic coordinator: Pierre.Francotte@uliege.be

Université de Liège | Fac. de Médecine
B36 niv.+5 | Lab. de Chimie Pharmaceutique (CIRM)
Quartier Hôpital | Av. Hippocrate 15 | B-4000 Liège, Belgium

 

The two guest lecturers are Frédéric Schmitz, PhD & Mallory Salvé, PhD.

Qualité en industrie pharmaceutique et affaires réglementaires

There is no MOOC associated with this course.