Objectives of Programme's Learning Outcomes

• Scientific skills
• Implement and independently carry out an experimental approach, validate a model by comparing its predications with experimental results, assess the limitations of the model's validity, and identify sources or error.
• Appropriately select measuring instruments, analyse and process the signal obtained
• Use basic mathematical tools
• Be a responsible researcher: - Know how to base their reasoning on data obtained from scientific literature. - Know how to integrate an ethical dimension in their reasoning. - Be loyal (to the facts, to the team, and to intellectual property). - Do not tamper with results. - Do not exploit the work of others. - Demonstrate experimental rigor.
• Professional integration skills
• Invest their knowledge and skills in professional scenarios
• Be in a hierarchical and professional environment, identify their skills and follow procedures, legislation, standards, among other security and safety measures

Learning Outcomes of UE

The objective of this course is to give a clear overview of the main quality standards used in the pharmaceutical industry: current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). We will study the basic principles common to those two quality standards and their specific applications.  

Content of UE

Role of the different industrial departments (Production, Quality Control, Research & Development (R&D), Quality Assurance(QA) + objectives of the regulatory authorities that check the implementation of the quality standards. Basic principles of good manufacturing practices + main differences between GMP and GLP. The focus will be set on the Good Documentation Practices (GDP), the analytical method validation and the equipment qualification.  

Prior Experience

Sans objet  

Type of Assessment for UE in Q1

• Oral examination
• Written examination

Q1 UE Assessment Comments

Depending of the number of students, the 1st examination session assessment will consist in: A written part (MCQ: 50%) and a oral part (50%): limited number of students A written part (MCQ + open questions: 100%): high number of students  

Type of Assessment for UE in Q3

• Oral examination
• Written examination

Q3 UE Assessment Comments

The 2nd examination session assessment will consist in a written part (MCQ: 50%) and a oral part (50%).  

Type of Resit Assessment for UE in Q1 (BAB1)

• N/A

Q1 UE Resit Assessment Comments (BAB1)