🇬🇧 Interactive Training in Applied GCP - Special focus on IT Tools and Electronic Data in Clinical Research » Luxembourg Institute of Health
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🇬🇧 Interactive Training in Applied GCP – Special focus on IT Tools and Electronic Data in Clinical Research

04/06/2024 13:00 an 17:30

Bitte beachten Sie, dass der Inhalt nur auf Englisch verfĂĽgbar ist.

Effective Clinical Research relies on a growing variety of IT tools and electronic data for most processes involved. IT Tools (computerised systems) and electronic data are an integral part of the Clinical Research project scope and are subject to the quality framework for Clinical Studies.

How can we apply Good Clinical Practice (GCP) principles to ensure reliable protection of study participants, including their rights and the integrity of research data, even when using rapidly evolving IT Tools for conducting Clinical Trials?

How can we ensure that the electronic data used, which is generated, handled, and stored within computerised systems, are reliable, and their integrity can be demonstrated to auditors and inspectors? The amended ICH-GCP(R2) has provided some clarity on computer system validation, electronic data and SOP requirements. For a deeper understanding the European Medicines Agency (EMA) has released the “Guideline on computerised systems and electronic data in clinical trials” that came into force in September 2023.

In this interactive advanced GCP Training, we will present the current quality framework for electronic data and computerised systems in clinical trials and discuss the resulting practical issues, hurdles, risks, and conflicts in their development and application.

Important information

  • A GCP certificate will be delivered upon participation & passing the final test (Otherwise certificate of attendance)
  • A GCP certificate is mandatory for all person working within studies including human subjects and is valid for a period of 2 years.

AGENDA

13h00Welcome and Introduction | Ingrid Klingmann
13h10 Quality principles in GCP today and tomorrow | Ingrid Klingmann
Q&A
13h45 Common quality issues detected | Laetitia Garcia
14h15 Basic quality aspects for electronic data and computerised systems used in clinical trials |
Michaela Rittberger

Q&A
15h15 Coffee break
15h35 Application of the EMA quality framework for computerised systems and
electronic data in clinical trials | Michaela Rittberger

Q&A
16h30 Open Forum Discussion | Ingrid Klingmann, Laetitia Garcia, Michaela Rittberger
16h45 MCQ Test
17h30 End of training

Trainers

Ingrid
Klingmann

MD, PhD, FFPM, FBCPM, GFMD

Expert in Medicines Development Planning and Site Management Support

Pharmaplex bv, and Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP), Brussels, Belgium

Michaela
Rittberger

Consultant and Auditor in the area GCP/PhV/DM/IT/GcLP, Averen, Munich, Germany

Sound knowledge in national and international requirements regarding computerised systems / electronic based systems and electronic records for medicines development

Laetitia
Garcia

Clinical Research Coordinator, Quality & Regulatory

Luxemburg Institute of Health, Luxembourg

Partner

Information: tania.zamboni@lih.lu

Training on 4 JUNE 2024

Training: 1:00 – 5:30 PM (test included)

Pricing

C1: FREE
LIH | IBBL | Students | LCSB | National Hospitals | National Healthcare Professionals | Researchers | PI | National Academia

C2: 100 €
International academia

C3: 200 €
Private companies

(For LIH Staff, please register via Mpléo)

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