From lab to patient: Understanding GMP, GLP & GCP in drug development
From lab to patient: Understanding GMP, GLP & GCP in drug development
29 & 30 September 2025
General context
Are you interested to discover the manufacturing and regulatory environment in the Pharma R&D Industry? You want to know where investigational products come from, how they are made and what rules and regulations must be followed? In this course, you will get a detailed overview on Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice.
By the end of this course, participants will be able to:
- Explain the core principles and purpose of Good Laboratory Practice (GLP) in commercial R&D environments.
- Describe the pharmaceutical manufacturing process and the role of Good Manufacturing Practice (GMP) in ensuring product quality.
- Interpret the regulatory framework that governs pharmaceutical development, including international standards and compliance obligations.
- Understand how GMP relates to Good Clinical Practice (GCP) and the requirements for investigational products used in clinical trials.
- Recognize the end-to-end quality management approach required to bring a drug from early development to clinical use.
This training offers a comprehensive and practical introduction to the regulatory environment of pharmaceutical R&D. Participants receive a clear, step-by-step explanation of GLP, GMP, and GCP, and how these standards are applied in real-world settings.
The course emphasizes interactive learning and practical application, facilitated by experienced trainers from ECCRT. Through examples, group discussions, and case-based learning, participants are actively involved in exploring the full journey of a drug—from early lab research to clinical use.
The focus lies on equipping participants with a broad understanding of quality systems, enabling them to navigate regulatory requirements in academic or industrial contexts.
PhD students, postdocs and staff scientists working at VIB who want to learn about GMP, GLP and GCP.
We got access to the presented slides already before the course started via a virtual campus. This was excellent to know what we could expect and to choose the most convenient way to take notes during the course. Especially the GMP and GCP courses were very well presented. Little workshops and questions during these courses nicely involved the participants. The venue was easy to reach, and the hotel surprised us with very good food and nice treats during the pauses.
Participant edition 2022
There was a good amount of time spent on interaction and the trainers were open to questions during or after the training.
Participant edition 2023
Program
Introduction to GLP (Good Laboratory Practice)
- What is GLP?
- Position of GLP in quality systems
- Scope of GLP
- Mutual acceptance of data
- GLP regulations
- GLP documentation
- Highlights of the GLP principles
- GLP inspection process
Lunch
Introduction to GMP (Good Manufacturing Practice)
- Introduction: Expectations of course participants
- Introduction in GMP (lecture)
- Basic principles of a biopharmaceutical manufacturing process (lecture)
- The main quality systems (lecture)
- Investigating a Deviation (workshop)
- Working in a pharmaceutical plant - departmental responsibilities
Introduction to GCP (Good Clinical Practice)
Drug Development in Steps:
- Investigational Medicinal Products
- Non-Clinical Research
- Clinical Research in Steps: Different Trial Types, Timeline & Cost
Rules for Clinical Research:
- Why Rules? Declaration of Helsinki and Good Clinical Practice Guideline
- Legislative Binding Rules for Clinical Research
- Case & Discussion
Principles of Clinical Trials
- Principles
- Case & Discussion
Stakeholders of Clinical Trials
- Sponsor, Investigator, Ethics Committee, Regulatory Authority
Investigational and auxiliary medicinal products
Life Cycle of Clinical Trials
- Trial Design, Trial Approval / Authorisation, Selection of Investigators & Study Subjects, Collecting Data, Trial Results, Milestones
Documents of Clinical Trials
Linking GMP, GCP, GDP
- Case & discussion
Practical info
29 September 2025 - 30 September 2025
Ghent - VIB/UGent FSVM II
Technologiepark 75
9052 Zwijnaarde
Belgium
29 September 2025 - 30 September 2025
Ghent - VIB/UGent FSVM II
From Ghent Sint-Pieters station, you can take a bus to Technologiepark. Please check Routeplanner De Lijn for schedules.
29 September 2025 - 30 September 2025
Ghent - VIB/UGent FSVM II
Looking for a custom cycling route? Try the online cycling route planner to easily and quickly identify the fastest, safest and/or most scenic route to any destination in Ghent.
Cycling route planner
Shared bicycles:
Several providers are active in the area.
Take a look at their platforms:
- Indigo Weel Pro app
- Bluebike
- DOTT
- BOLT eBikes
- Donkey Republic
There are also some public bicycle pumps at the park.
29 September 2025 - 30 September 2025
Ghent - VIB/UGent FSVM II
There is only one entrance to Technologiepark. At the entrance, please take a ticket - Parking is only allowed in regular parking spots (for instance in front of the building) and in the parking tower. Parking alongside the roads or in other places where there is no regular parking is prohibited.
29 September 2025 - 30 September 2025
Ghent - VIB/UGent FSVM II
Room L4