GMP - GLP - GCP

GMP - GLP - GCP

Leuven, Park Inn by Radisson

25 & 26 May 2020

General context

We hope that we will be able to offer this training as scheduled. However, if  a live training would not be possible due to measurements that we need to take to prevent spreading of the Corona virus, this training will be replaced by 8 webinars of each 2 hours that will take place end of May and June. The exact dates will be communicated asap.

 

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.

Objectives

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.
Approach

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”.

Event intended for

PhD students, postdocs and staff scientists working at VIB who want to learn about GMP, GLP and GCP.

Extra information
  • This training is free for VIB participants.
  • The fee for non-VIB Academics is € 100 for both days (VAT incl).
  • 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

Trainers

Martijn Baeten

Martijn Baeten graduated in 2004 as master in bio-engineering at the university of Brussels. He started his career as scientific research associate at Beta-Cell N.V., a company involved in xenotransplantation for diabetes in 2005. In 2008 he returned to the University of Brussels as a scientist on cancer immunology. He was also the head of the core facility flow cytometry at the University of Brussels.

From 2011 he started working as a GLP inspector at the Institute of Public Health (called Sciensano since 2018). He is also an internal auditor for ISO 17025 & 15189 and ISO 9001 for Sciensano. At the moment, he is also involved in the implementation of a ISO 27001 quality system.

As member of the Belgium GLP monitorate, he was involved in the drafting of the new OECD document on computerised system. He is also an active member of the OECD GLP working group and steering group for OECD training courses for GLP inspectors.

As member of the steering group for OECD training courses, he presented several topics during the OECD training courses for GLP inspectors in 2013 (Tokyo), 2015 (Hyderabad), 2017 (Krakow) and 2019 (Cape Town). Topics covered included “Use of computerized systems in GLP”, “Equipment, material and reagents”, “Roles and responsibilities”, “QA program”. As trainer, he also prepared and gave several workshops on IT validation in GLP, Conducting study audits, Study Reconstruction & Data Integrity….

Since September 2019, he coordinates the working of the Belgian GLP monitorate.

Jolanda Muurman

Jolanda Muurman is Training and Development Manager at the Biotech Training Facility (Leiden). She has a BSc in Biotechnology and obtained a master degree in Management at the university of Greenwich.  She has a broad experience in working in multi-disciplinary project structures in Drug Substance and Drug product development. Also, she has been involved in hosting inspections from clients and authorities frequently and have a broad experience in all facets of GMP. At the Biotech Training Facility, she is responsible for development and organization of GMP trainings in a fully equipped mock-up biotech facility.

Marleen Verbeeck

Marleen Verbeeck, is a trainer/coach and has been working at the European Centre for Clinical Research Training (ECCRT) since 2004.

She obtained her PhD in molecular biology at the University of Utrecht in 1990. After fundamental research positions at the universities of Utrecht, New York, Leuven and Maastricht, she changed her academic career in 1995. She gained solid grounding in clinical research, first as a clinical research associate, later as a medical writer combined with a position as trainer.

Marleen enjoys developing, lecturing, evaluating and developing comprehension tests of courses as well as boosting confidence and competence of clinical research professionals with different experience levels from the pharmaceutical, medical device industry and non-profit research organisations.

She has more than 15 years of educational expertise. She is author of scientific papers, clinical trial study protocols (phase I - IV) and clinical study reports. She has experience in medical areas such as : CNS, Gastroenterology, Gynaecology, Rheumathology, Cardiology, Oncology, Orthopaedics and Immonutherapy.

In addition, recently Marleen is also a regulatory consultant on European clinical trial legislation. Acquiring and conveying knowledge has always been her interest throughout her professional career.

Program

Day : 25 May 2020

Introduction to GLP

After having put the origin of GLP in an historical context, focus is put on the five major principles within the GLP guidelines. For each of these principles: Resources, Characterization, Rules, Results and Quality Assurance a short overview of the most important aspects covered by them is given.

With this basic background, the GLP Principles are translated into an R&D environment where the main focus is on obtaining results that are reliable, repeatable, auditable and recognized by scientists throughout the world.

How this can be achieved is tackled in the section on documentation in which first of all the importance of being able to make the distinction between facts and fiction is illustrated. Tools that can help on implementing a basic documentation approach are then discussed.

Finally, the GLP Principles are put in a broader perspective towards quality management and this is illustrated by a short review of the 18 papers now published within the GLP Principles papers and covering topics such as field studies, multiple site studies, peer review in histopathology and computerized systems.

Topics covered in this session:

  • Historical perspective of GLP
  • Major Principles
  • GLP in R&D
  • Documentation
  • GLP Today

 

GMP

  • Introduction
    • Expectations of the course participants
  • Introduction in GMP (lecture)
    • GMP, a brief introduction, regulations and guidelines
    • The GLP, GCP and GMP landscape
    • The world according to pharma
    • How to implement? Insight, execution/performance and behavior, documentation
    • GMP - assurance and principles, part I, II, III
    • GMP - how do they do it?
    • Pharmaceutical supply chain
  • Basic principles of a (bio)pharmaceutical manufacturing process (lecture)
    • Reference to the guidelines
    • Biotech product characteristics
    • API/bulk drug substance manufacturing and critical quality attributes (CQA’s)
    • Drug product manufacturing and critical quality attributes (CQA’s)
    • General manufacturing requirements
    • Back-up: cell line management and impurities
  • The main quality systems (lecture)
    • Deviations
    • CAPA
    • Change control
  • Critical Quality Attributes (workshop) or Investigating a deviation (workshop)
  • Working in a pharmaceutical plant - departmental responsibilities
    • Producing at Manufacturing Department
    • Maintenance by the Facilities Department
    • Testing at the QC Department
    • The tasks of the QA Department and the role of the QP
    • The Regulatory Affairs Department

 

Day 2: 26 May 2020

GCP

  • Drug development in steps:
    • Pre-clinical research
    • Investigational medicinal products
    • Clinical research in steps (phase 0 to phase IV)
  • Good clinical practice: why and what?
  • Legislative binding rules for clinical research
  • Stakeholders of clinical trials
  • Principles and documents of clinical trials
  • Life cycle of clinical trials
  • Responsibilities of the Sponsor in clinical trials
  • Linking GMP, GCP and GDP
  • Investigational products’ documents
  • Quality assurance
  • Audit/inspection findings
  • Sponsor’s positions in clinical research
  • Course closure

Practical info

25 May 2020 - 26 May 2020

Park Inn by Radisson Leuven

Martelarenlaan 36
3010 Leuven
Belgium

25 May 2020 - 26 May 2020

Park Inn by Radisson Leuven
Public transport

The hotel is located 300m from Leuven Central Station. The hotel connects to Leuven Central Station by a pedestrian bridge.

25 May 2020 - 26 May 2020

Park Inn by Radisson Leuven
Parking

Park Inn hotel has no own parking. It is possible to park underground in P1-Parking Station Leuven, Martelarenlaan 4, 3010 Leuven.

25 May 2020 - 26 May 2020

Park Inn by Radisson Leuven
Location contact

+32 16 61 66 02

sales.leuven@parkinn.com

Contact

VIB training
Tel: +32 9 244 66 11
Mail: training@vib.be