GMP - GLP - GCP
26 & 27 September 2024
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
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
26 September 2024 - 27 September 2024
Leuven - Park Inn by Radisson
Martelarenlaan 36
3010 Leuven
Belgium
26 September 2024 - 27 September 2024
Leuven - Park Inn by Radisson
The hotel is located 300m from Leuven Central Station, just a short 5 minute walk.
26 September 2024 - 27 September 2024
Leuven - Park Inn by Radisson
Using your bike for longer distances? Check Cycle Highways.
26 September 2024 - 27 September 2024
Leuven - Park Inn by Radisson
Underground P1-Parking Station Leuven, Martelarenlaan 4, 3010 Leuven or parking De Bond, Martelarenlaan 18, 3010 Leuven.
26 September 2024 - 27 September 2024
Leuven - Park Inn by Radisson
+32 16 61 66 02
sales.leuven@parkinn.com