Welcome

General Information
Welcome to the website of the GUIDE Methodology course “Good Research Practices: GCP/GLP”. Details on the next course are as follows.

GUIDE Methodology Course: “Good Research Practices: GCP/GLP”
Duration:
March 12, 2018 - March 23, 2018.
(Partial participation possible)

Location:
UMCG - Graduate School of Medical Sciences
Building: MWF-Complex
Antonius Deusinglaan 1
9713 AV GRONINGEN
The Netherlands

Audience

The course is intended for professionals who want to perform biomedical/ biopharmaceutical research according to the standards required by the international authorities for drug registration (market authorization).

Accreditation

Accredited by the SFG (Stichting Farmaceutische Geneeskunde; Foundation for Pharmaceutical Medicine): 25 points
Accredited by Graduate School for Drug Exploration GUIDE (RuG): 3 EC points

Topics

General principles of quality management applied to drug research: Good Research Practices: GxP’s and ISO-9000
(Inter-)national legal and ethical aspects on new drug development
Preventing scientific misconduct and fraud during (bio-)medical research
Good Clinical Practice (GCP) (worldwide history; theory/legislation; practice: preparing, performing and evaluating a clinical study with a potential new medicine)
Good Laboratory Practice (GLP) (worldwide history; theory/legislation; practice: organizational and technical aspects in the (bio-)analytical laboratory; preparing, performing and evaluating a (bio-)analytical study)
Implementation of GxP’s
Compliance with GxP’s
On the spot instructions in GCP-accredited clinical research centre (excursion)
On the spot instructions in GLP-accredited (bio-)analytical laboratory (excursion)

Aim

The aim of this course is to increase the knowledge on methods to improve the integrity and the quality of
(bio-)medical research. Quality management of drug research will be discussed by introducing the legal requirements of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and by discussing the international quality standard ISO-9000. After having attended this course the participants will be able to successfully perform their research according to the state of the art (legal) international quality standards.

Organisation

The course takes place during ten days from 09:00 (sharp!) to approximately 13:00 h. and is a mixture of lectures, site visits to a GCP-certified clinical research centre and a GLP-certified laboratory, demonstrations, videotraining and case studies (group presentations by the students).

The subject of the course is totally new to most of the participants and therefore it was decided to provide extensive documentation on the website.

Transferring the knowledge of the subject requires a substantial number of lectures which will be given by a team of speakers from academia, organizations of professionals, authorities (including the Health Inspectorate), patient organisations, pharmaceutical industry and contract research organisations. All of them are acknowledged experts in the field.

Of all lectures abstracts are made available on the website.

It is important to read the abstracts the day before the presentation will be given. This is essential for a good transfer of knowledge and for a good discussion on the material presented during the lectures.

All slides of the lectures are available on the website www.pharmadvices.com. To open the presentations you need a login-code. This code will be made available for the participants a few days before the start of the course. This code is valid up to one week after the end of the course.

Most students find it helpful to have a printed hand-out of the slides and bring this to the class room during the presentation. I strongly recommend this procedure but leave the initiative at your side.

Alternatively you may use your notebook or tablet and download the presentations.

In addition to the slides of the lectures extensive documentation on the (inter-)national laws and regulations on good research practices are placed on the website (Parts I, II, III). This documentation is divided in Good Clinical Practices, Good Laboratory Practices and Research Quality Management.

Some of these documents are essential to understand the content of this course and need to be studied before or during the course. This is indicated in the document. Others are given for the sake of completeness on the subject. Some of the latter will be needed during the preparation of your own presentation.

Giving a presentation by the participants is an essential part of this course. This will be done in teams of 3-5 people. But each student is responsible for a part of the presentation and has to compose it and to present it. The team is responsible for the total of the presentation.

On the first day of the course we will establish the teams. Then you also will receive the subject of your presentation. These presentations will be given on the last days of the course.

Although the teamwork is important, it is the individual contribution that counts most.

Originality is of paramount importance: preparing and presenting the lecture replaces an examination. So, this is the moment of formal review/checking of the knowledge on the subject of the course by the course leader.

Preparing the presentation will take much time, also during the evening hours (please realize that you will get three study points for participating in the course, which is the equivalent of three weeks of study!).

During this presentation the participant has to demonstrate that he/she has received sufficient knowledge on the subject during this course.

Faculty

Distinguished faculty from university, government, (GCP- and GLP-inspectors; CCMO), industry and CRO’s.

Evaluation

At the end of the course the participants have to fill out an Evaluation Form.

Your answers are for us a quality check and are very helpful for us during our continuous attempts to optimize the course.

Reward

The reward for this course is 3 EC.

More information
PharmAdvices
P.O. Box 10
NL-7920 AA Zuidwolde
The Netherlands

Phone : +31 523 649 113
Mobile : +31 65 11 98 224
Email: [email protected]

GUIDE
Adress: Antonius Deusinglaan 1,

Building 3217 "De Brug" room 7.31
NL - 9713 AV Groningen
The Netherlands
Postal address: P.O. Box 196,
NL - 9700 AD Groningen
The Netherlands
Phone: +31 503 633 163
Email: [email protected]