Introduction

There is a scientific policy and regulatory desire for validated and internationally accepted in vitro methods (e.g., OECD test guidelines or ISO standards). To accommodate the needs of receiving authorities, a number of in vitro methods, often based on the use of human cells and tissues, have been submitted to international validation bodies during the last two decennia. It was agreed that technical guidance is needed to standardise and advance the development of robust and reliable in vitro methods suitable for regulatory purposes. The OECD approached EURL ECVAM to coordinate the drafting of GIVIMP for the development and implementation of in vitro methods for regulatory use in human safety assessment which is also equally applicable to non-guideline or not internationally recognised in vitro methods.

An Expert Group was established in 2015 to develop such a guidance document. The first draft of the guidance document was prepared following a GIVIMP meeting on the 24 and 25 February 2015 in Ispra, Italy (Annex C: EURL ECVAM GIVIMP meeting 24-25 February 2015) with additional input from experts who could not be present at the meeting. Expert input was received from EURL ECVAM, European receiving authorities (European Food Safety Authority EFSA, European Medicine Agency EMA, European Chemicals Agency ECHA), from the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL, e.g., from the Belgian, Dutch, Italian, Spanish and Swedish laboratories), from ECVAM's Stakeholder Forum (ESTAF, e.g., the European Society of In vitro Toxicology), from the EU and OECD Working Group on Good Laboratory Practice GLP (e.g., delegates from Belgium, The Netherlands, The United Kingdom, Poland, Italy, France, Singapore), from Replacement, Reduction and Refinement (3Rs) Centres (e.g., Centre for Alternatives to Animal Testing, CAAT), from regulatory agencies (e.g., RIVM), from scientists from large industries, Small and Medium Enterprises (SMEs) and from international scientists with expertise in stem cells, cell biology, GLP and in vitro methods.

Following the first OECD commenting round of the draft document that took place in the autumn of 2016, a draft version, revised by the OECD Working Group on GLP (WG GLP) and the nominated experts from the Working Group of the National Coordinators of the Test Guidelines Programme (WNT), was circulated in September and November 2016 for review by all 37 members of EU-NETVAL. The OECD GIVIMP Expert Group provided input through teleconferences, a face-to-face meeting (Annex D: OECD GIVIMP meeting 23-24 March, 2017), and two rounds of written comment. The group agreed on content, structure, and wording of the GIVIMP. A further commenting round following revision of Chapter 4.3 on media (specifically, the use of animal serum in cell culture) and Chapter 8 on method performance, by the VMG-NA and GIVIMP Expert Groups, took place in November 2017.

GIVIMP has been updated by Sandra Coecke and Gerard Bowe, and the members of the OECD GIVIMP expert group.

The main authors drafting the version used for the first commenting round are:

Maria Antonietta Antonelli

Laura Pioppo

European Medicines Agency (EMA), London, United Kingdom.

Maria Astridou

Annamaria Rossi

European Food Safety Authority (EFSA); Parma, Italy.

Bohumila Bichlmaier Suchanová

Laura Rossi

European Chemicals Agency (ECHA), Helsinki, Finland.

Camilla Bernasconi

Ann-Charlotte Bostroem

Gerard Bowe

Sandra Coecke

Thomas Cole

Elisabeth Joossens

Ingrid Langezaal

Anne Milcamps

Sander van der Linden

Maurice Whelan

European Commission, Directorate General Joint Research Centre, Directorate F-Health, Consumers and Reference Materials, F.3 Chemicals Safety and alternative Methods, The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), Ispra, Italy.

Hui Da Chong

Singapore GLP Monitoring Authority, SPRING Singapore -– Singapore Accreditation Council.

Rita Cortvrindt

Vito, Mol, Belgium.

Laureano Cuevas

Centro Nacional de Microbiologia, Majadahonda, Spain.

Agnieszka Dudra

Bureau for Chemical Substances, Lodz, Poland.

Eugene Elmore

University of California Irvine, Trabuco Canyon, Unites States.

Chantra Eskes

SeCAM, Magliaso, Switzerland.

Kristina Fant

Emma Pedersen

RISE Research Institutes of Sweden AB, Borås, Sweden.

Andrew Gray

United Kingdom GLP Monitoring Authority, The Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom.

John Harbell

JHarbell Consulting LCC, Dallas, United States.

Minne Heringa

RIVM, The National Institute for Public Health and the Environment, Centre for Safety of Substances and Products, Bilthoven, The Netherlands.

Delyan Ivanov

University of Nottingham, Cancer Biology Queens Medical Centre, Nottingham, United Kingdom.

Guido Jacobs

WIV-ISP, Scientific Institute of Public Health, GLP-Monitorate-Brussels, Belgium.

Rob Jaspers

Health Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, The Netherlands.

Marcel Leist

University of Konstanz, Konstanz, Germany.

Thomas Lucotte

ANSM, Inspectorate Department, Saint-Denis, France.

Richard McFarland

Policy Office of Cellular, Tissue, and Gene Therapies Center for Biologics Evaluation and Research United States Food and Drug Administration, USA

Marisa Meloni

Vitroscreen SRL, Milano, Italy.

Maurits-Jan Prinz

European Commission, Directorate General Internal Market, Industry, Entrepreneurship and SMEs, Brussels, Belgium.

Glyn N Stacey

United Kingdom Stem Cell Bank, Advanced Therapies Division, NIBSC, Medicines and Healthcare products Agency, United Kingdom.

Emanuela Testai

Istituto Superiore di Sanita, Rome, Italy.

Frederique van Acker

Triskelion, Zeist, The Netherlands.

Iwona Wilk-Zasadna

Novartis Vaccines, Basel, Switzerland.

Acknowledgements are also made to the EURL ECVAM colleagues that reviewed and gave useful additional input: Susanne Belz, Mounir Bouhifd, Laura Gribaldo, Tomislav Horvat, Tracey Holley, Annett Janusch Roi, Roman Liska, Alfonso Lostia, Agnieszka Lidia Swiatek, Nicholaos Parissis, Francesca Pistollata, Anna Price, Clemens Wittwehr, Andrew Worth.

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