training

GMP - GLP - GCP

GMP - GLP - GCP

translational research
Location:

Ghent, Clemenspoort

Start date:

18 October 2021

Duration:

18 & 19 October 2021

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

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

GLP (Good Laboratory Practice)

-
  • Historical Perspective of GLP
  • Major Principles 
  • GLP in Research & Development
  • GLP Documentation
  • GLP Today
-

Lunch

GMP (Good Manufacturing Practice)

-

Introduction: Expectations of course participants

Introduction in GMP (lecture)

  • GMP, a brief introduction
  • The GLP, GCP, GMP landscape
  • The world according to pharma

How to implement?

  • Insight, execution/performance and behavior
  • GMP – Assurance and principles
  • 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) o General Manufacturing requirements
  • Back up: cell line management and impurities
  • Part II: GMP for Active Product Ingredients
  • Part III: Additional Documents

The main quality systems (lecture)

  • Deviations & OOS
  • CAPA
  • Change Control

Investigating a Deviation (workshop)

Cases for investigation:

  • Equipment breakdown in grade A
  • Filter test failure in an aseptic manufacturing process
  • Too much anti-foam added during cell culturing

Working in a pharmaceutical plant - departmental responsibilities

  • Producing at manufacturing department
  • Maintenance by the Facilities department
  • Testing at the QC department
  • Tasks of the QA department and the role of the QP
  • The Regulatory Affairs department

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

Linking GMP, GCP, GDP

  • Investigational and Auxiliary Medicinal Products

Stakeholders of Clinical Trials

  • Sponsor, Investigator, Ethics Committee, Regulatory Authority

Principles and Documents of Clinical Trials

  • Clinical Trial Principles “Which is the correct missing word?”

Life Cycle of Clinical Trials

  • Trial Design, Trial Approval / Authorisation, Selection of Investigators & Study Subjects, Collecting Data, Trial Results, Milestones
-

Lunch

-

Sponsor’s Responsibilities in Clinical Trials

  • GCP – GMP – GDP responsibilities

Investigator’s Responsibilities in Clinical Trials

Investigational Products’ Documents

Quality Assurance & Audit/Inspection Findings

  • Quality Assurance & difference between audits & inspections?
  • Is it a serious? Common findings & how to avoid them
  • Difference between Regular Medical Care & Clinical Trials

Sponsor’s Positions in Clinical Research in Clinical operations, Data management, Regulatory Departments, etc.

Course Closure

Practical info

Location & Venue
Clemenspoort Gent

Overwale 3
9000 Ghent
Belgium

Public transport
Clemenspoort Gent
Public transport

The train station Ghent St-Pieters is only 250 m away. We have 40 bike lots.

Route description
Clemenspoort Gent
Parking

We offer parking lots (1.20 € per hour). GPS address: Sint-Denijslaan 251.
Please take the neem the exit SPORTHAL HoGent (not Campus HoGent) and drive all the way to the end, so past the parking slots of HoGent.

Venue contact
Clemenspoort Gent
Location contact

+32 476 46 10 40

info@clemenspoort.be