GxP online courses

ICH GCP E6 (R3) training for sponsors, investigators, regulators and others.

GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Everyone involved in the conduct of clinical research must be competent to perform their tasks, qualified by education, training and experience. All available training courses address the GCP aspects of this requirement and have been updated with ICH GCP Integrated Addendum E6 R3.

All our courses are accredited by the Royal Colleges of Physicians of the United Kingdom and the SOTE Continuing Education Center (Semmelweis University), thus all certificates released with Accreditation numbers are accepted by Hungarian Competent Authority (Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK) and the Central Ethics Committee (ETT-KFEB) for Regulatory submissions.

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GCP face to face (ILT) courses

We provide customized instructor-led (ILT) or virtual instructor-led training (VILT) tailored to our clients' needs in conjunction with Brookwood Global.

The venue of the face-to-face ILT is chosen by the client.

Online courses

Essential GCP for Investigators E6(R3)

Comprehensive online training on investigator ICH GCP E6(R3) responsibilities available in English, and shortly in Hungarian.

Based on the investigator responsibilities laid down in Sections 2 and 4 of the ICH GCP E6(R3) guidelines.

Meets the minimum requirements for the mutual recognition of investigator GCP training laid down by TransCelerate BioPharma Inc in 2025.

The training is divided into key sections, each with interactions.

Integral quizzes and an online multi choice test at the end of the training confirm knowledge.

Those who attain the 80% pass mark receive certification.

Test answers can be reviewed and the test retaken.

Takes approximately 2 hours

Participation fee:

140 EUR

(55.000 HUF + VAT)

GCP has changed –

what’s new in ICH E6(R3)

This 45-minute online course aims to update sponsor and service provider personnel who already have current GCP training in place.

It covers the new requirements introduced by the latest E6(R3) Annex 1 guideline. It emphasises the need for a risk proportionate approach to trial management that focuses on the rights, safety and well-being of participants and the reliability of trial data.
It identifies some of the trickier new requirements faced by sponsors, service providers and investigators.

Takes approximately 45 mins.

Participation fee:

130 EUR

(50.000 HUF + VAT)