Under the new medical device requirements all trials with devices must be conducted in compliance with biomedical or GCP requirements. The regulatory requirements for trial conduct are defined in national law, by the medical device laws and by the ISO 14155. This handy GCP pocket brings the regulatory requirements together in a single consolidated reference aid. Understand the specific regulatory requirements to ensure well-structured, scientifically valid, quality trial data is obtained. A must for anyone involved with medical devices regulatory affairs, quality assurance, clinical research and reimbursement! Including the following annexes: general definitions, the essential requirements, classification rules, clinical evidence rules, adverse event reporting, post-market clinical follow-up, the Declaration of Helsinki, Declaration of the rights of the patient and regulatory references. read more

english

February 2009

ISBN: 978-90-78027-05-8

€ 29.00

Quantity:

Thesis for the fulfilment of the requirements for the Degree of Doctor in Social Health Sciences at the University of Ghent. Chapter 1 gives an overview of the medical device regulatory requirements and the basic principles of compliance.In Chapter 2 the GCP environment as it applies to medical devices and related ethical issues for conducting medical device trials is discussed. In Chapter 3 the various trial methodologies available and how they can or cannot be applied to medical devices is examined. In Chapter 4 the clinical trial method and outcome of a Class I medical device trial are discussed. Chapter 5 concludes with an overview of future regulatory and ethical developments.read more

English, 178 pages

August 2008

ISBN: 978-90-804771-8-6

€ 60.00

Quantity:

Written by H. Pieterse and in handy A6 format. Official Dutch translation of the ICH GCP guideline with information on a GCP compliant quality system for individual investigators and hospitals conducting clinical research. Including rules and regulations for observational studies. In the meantime more than 8000 copies have been sold.

Dutch, 138 pages

Sixt Edition: April 2010

ISBN: 90-804771-5-x

€ 24.00

Quantity:

A guide to medical device Good Clinical Practices compliance. Authors: M G de Jong and H Pieterse A practical hands-on compliance guide on how to conduct medical device clinical trials in compliance with prevailing international Good Clinical Practices and medical device requirements.

For the contents read more

English, 270 pages

First edition: July 2007

ISBN: 978-90-78-027-02-7

€ 179.00

Quantity:

Written by the Dutch Working party for the implementation of the European Clinical Trial Directive 2001/20/EC and edited by H. Pieterse, M.Sc – Heerhugowaard, The Netherlands. © 2005 Ministry of Health, Welfare and Sport. Reproduced with permission of the Ministry of Health, Welfare and Sport, the publisher. Price for more than 10 copies: 10% discount. For the contents read more

English, 60 pages

Second edition, October 2005 with errata

ISBN:

€ 12.00

Quantity:

PCS Guideline for Clinical Research concerning the conduct of biomedical clinical research written by H. Pieterse, M.Sc and edited by P. Meewisse, M.Sc and C.H.M. Kleemans L.L.M - Heerhugowaard, the Netherlands. Translated by Pharma Lingua, W. Ezerman, M.A. read more

English, 64 pages

First Edition: April 2000

ISBN: 90-804771-2-5

€ 35.00

Quantity:

Dutch version of "Plain Common Sense Guideline For Clinical Research".read more

Dutch, 48 pages

Second Edition: November 1999

ISBN: 90-804771-1-7

€ 25.00

Quantity: