Clinical Trial Inspections: Preparing for a good outcome

European Centre for Clinical Research Training (ECCRT)
21.04.2015  Brussels, Belgium
Course Content
This one day course is designed to provide a basic understanding of the inspection process - under special consideration of FDA inspections - in clinical drug development and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome.
Inspections are a fact of life when running clinical trials. This course will provide delegates with information about how inspections are conducted, advice on preparing for inspections and providing information to ins
Learning objectives, training objectives
Understand how inspections are conducted. Hands on information about how to prepare the team and documentation for a smooth inspection. Data and document requirements specific to inspections. Know how to prepare for sponsor/CRO and site inspections.
Target Audience
The course is developed for all staff who may be involved during an inspection, such as clinical operations staff, CRAs, project managers, investigators and their staff.
Typical postgraduate careers and job opportunities
CRA, Clinical Research Associate, PM, Project Manager
ISO9001:2008/ Q-for
Local Organizer

Enquiries and Registration:

Ms. Sunita Kelecom
Clinical Research
Type of degree
Certificate of attendance
1 day
EUR 850,00
Organizer contact info
Marcel Broodthaers plein 8b5
1060 Brussels
"Going International promotes access to education and training for all regardless of social, geographic and national borders."

Österreichische Akademie der ÄrzteSwiss Tropical and Public Health InstituteHelix - Forschung & Beratung WienAlumni Club Medizinische Universität WienAGEM - Arbeitsgemeinschaft Ethnologie und MedizinÄrzte der WeltHilfswerk AustriaCentro per la Formazione Permanente e l'Aggiornamento del Personale del Servizio Sanitario