Medical Translation in Ghent: UZ Gent, VIB, Ablynx and Biocartis

Gand is one of the European capitals of biotechnology. The VIB (Vlaams Instituut voor Biotechnologie), Ablynx (now a Sanofi subsidiary) and Biocartis have set up their research centres there alongside the UZ Gent. Medical translation in Gand takes place in a highly regulated context: EMA files, clinical trial reports, genomic publications and multilingual consents for the patients of the Gand clinics.

Gand, a hub of Belgian biomedical research

The UZ Gent (UMC Gent) is one of the largest university hospitals in Belgium, with more than 1,000 beds and cutting-edge departments in oncology, paediatric cardiology and transplantation. Backed by Ghent University (UGent), it participates in many multicentre European clinical trials that require the translation of protocols and consent forms into the languages of each participating country. The AZ Sint-Lucas Gand and the AZ Maria Middelares complete the Gand hospital offering, welcoming patients from all over East Flanders as well as foreign patients, particularly Turkish and Arabic.

On the industrial side, Gand has experienced a real biopharmaceutical revolution over the past twenty years. Ablynx, founded in 2001 from a UGent spin-off and a pioneer of nanobodies (single-domain antibodies derived from camelids), was acquired by Sanofi in 2018 for 3.9 billion euros. Its R&D site remains active in Gand, producing voluminous regulatory documentation intended for the EMA and the FDA. Biocartis, listed on Euronext Brussels, develops molecular diagnostic solutions whose leaflets and user manuals must be translated in accordance with the IVD regulation (EU 2017/746). The VIB (Vlaams Instituut voor Biotechnologie), with its genomics centre based in Gand, publishes massively in English and collaborates with industrial partners that require certified translations for their intellectual property files.

This density of biomedical players makes Gand one of the Belgian cities where the demand for medical and regulatory translation is the most sustained and the most demanding in terminological terms. A generalist translator cannot meet these needs: a command of the vocabulary of nanobodies, molecular diagnostics or functional genomics is essential to produce documents accepted by the regulatory agencies.

Types of medical and regulatory documents translated in Gand

• Scientific publications UZ Gent and VIB: translation from English into Dutch for dissemination among Flemish practitioners, and from Dutch into English for submissions to international peer-reviewed journals
• MA files (Marketing Authorisation): translation of the CTD modules for submissions to the AFMPS (Federal Agency for Medicines and Health Products), in compliance with the Belgian regulatory templates and the EMA guidelines
• Clinical trial reports Ablynx/Biocartis: translation of the Clinical Study Reports (CSR) and the clinical study reports into English for submission to the EMA, with ICH E3 terminology and compliance with the standardised presentation formats
• Genomic research protocols VIB: translation of the sequencing protocols, the bioinformatics analysis guides and the laboratory manuals used in the multicentre studies coordinated by the VIB
• Informed consents in Turkish and Arabic: consent forms for the patients of the Gand clinics whose mother tongue is not Dutch, in accordance with EU regulation 536/2014 and the requirements of the local Ethics Committee
• IVD medical device leaflets: translation of the instructions for use, the commissioning leaflets and the technical data sheets of the in vitro diagnostic devices of Biocartis, in accordance with the regulation EU 2017/746 (IVDR)

Regulatory requirements: EMA, AFMPS and the IVDR regulation

Gand biomedical companies operate in a particularly dense regulatory environment. For medicines for human use, the AFMPS is the competent national authority that coordinates with the EMA for centralised procedures. The MA files must be submitted in the CTD format (Common Technical Document) and the translations must comply with the EMA's QRD templates (Quality Review of Documents) for the leaflets and the SmPCs. MedDRA terminology is mandatory for the coding of adverse effects.

For in vitro diagnostic medical devices such as those of Biocartis, the regulation EU 2017/746 (IVDR), fully in force since May 2022, imposes strict translation requirements: the instructions for use and the labelling must be available in the official language of each member state where the device is marketed. In Belgium, this means French, Dutch and German, plus more often English for professional users. These translations are an integral part of the technical file submitted to the notified body.

For clinical trials, EU regulation 536/2014 requires that the informed consent form be drafted in the language of the participant and be understandable by a non-specialist. In a multicentre context involving the UZ Gent and partner hospitals in several countries, our medical translators produce language versions adapted to each site, terminologically validated and reviewed by native proofreaders.

Indicative turnaround times and rates for medical translations in Gand

The rates indicated are exclusive of specialised review for documents submitted to a regulatory agency (EMA, AFMPS, IVDR notified body). For critical regulatory projects, we recommend a review by a second pharmaceutical translator, included in our standard offer on quote. VAT not applicable (art. 44 §3 Belgian VAT Code).