GMP - GLP - GCP

GMP - GLP - GCP

Bio-Accelerator Meeting Center Ghent

Technologiepark 21
9052 Zwijnaarde
Belgium

05 June 2019
06 June 2019

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.

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 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

Trainers

Leo Huybrechts

Leo obtained his Ph.D. in Endocrinology in 1988.

He started his career in the CRO business in 1994, as Director Quality Assurance for BARC Central Laboratory, where he was responsible for the implementation of both GLP and ISO45001/ISO17025 systems in the laboratory.

In 2002, Leo moved to Omnicare Clinical Research (now Theorem/Chiltern) where he succesfully acted as account director for biotech companies, bringing in large global projects.  He was also nominated as Country Manager for both the offices in The Netherlands and Belgium.  Position in which he could demonstrate his managerial skills.  This lead to his promotion to International Director Global Proposal Development where he lead an international team of proposal developpers situated from Australia over India to Europe.

In 2011 he moved back to BARC as Director Global Integrated Processes and later as COO Europe and Asia. In these functions Leo realized following major projects:

  • Harmonization of processes and procedures in the different locations
  • Selection and Set up of the China branch
  • Selection and Set up of the Singapore branch
  • Lead of the business team analysing and developing a new Clinical Trial Management System (Succesfully launched in 2015)

With the extension of the Belgian group within Cerba Health Care, Leo was asked in 2015 to take up the leadership of the QA department for the Belgian medical laboratories together with the global QA role for the BARC group.  In this role, he succesfully guided the switch from ISO17025 to ISO15189 in the medical laboratory.  He also laid the fundation of an extensive internal and external audit program covering all aspects of both ISO15189 and GCP requirements.

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 : 5 June 2019

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: 6 June 2019 

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

Bio-Accelerator Meeting Center Ghent

Technologiepark 21
9052 Zwijnaarde
Belgium

Parking

Route description

There is free parking available in front of the building.

Public transport

Itineraries:

At Gent St Pieters station you can take the following city buses:Buses 70, 71 and 72 ("Tramstraat"). You get off at the stop marked "Bollebergen" (on the Grote Steenweg Noord). The Technology Park is straight in front of you on the other side of the soft verge.

There is also a shuttle bus from Gent-Sint-Pieters, more information can be found here.

 

Contact

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