GMP - GLP - GCP
25 & 26 September 2023
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.
After this training, you will:
- Understand the basics of Good Laboratory Practices (GLP) in a commercial R&D setting.
- Understand the context of the pharmaceutical industry and the quality rules required to manufacture a drug product.
- Understand the international regulation context (Good Manufacturing Practices, GMP)
- Be able to make the link GMP with the requirement of GCP (Good Clinical Practices) in a clinical research environment.
ECCRT aims for the best return on investment for the participant. Our goal is for trainees to leave the course with the capacity to use the information provided in the most practical way. Our expert trainers always encourage interactivity in the group. ECCRT supports the statement: “You tell me, and I forget. You teach me, and I remember. You involve me, and I learn”.
PhD students, postdocs and staff scientists working at VIB who want to learn about GMP, GLP and GCP.
- This training is free for VIB participants.
- The course is not open for non-VIB participants.
- Note that upon no show without valid justification a fee of € 100 will be charged and you will be blacklisted for the VIB training program for 1 year. Click here for more information
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
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
25 September 2023 - 26 September 2023
Ghent - VIB/UGent FSVM II
Technologiepark 75
9052 Zwijnaarde
Belgium
25 September 2023 - 26 September 2023
Ghent - VIB/UGent FSVM II
From Ghent Sint-Pieters station, you can take a bus to Technologiepark. Please check Routeplanner De Lijn for schedules.
25 September 2023 - 26 September 2023
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.
25 September 2023 - 26 September 2023
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.