Drug Safety and Clinical Trials - A Concise Workshop
European Centre for Clinical Research Training (ECCRT)
Archive
28.04.2011 Brussels
Course Content
This foundational one day course on the essential aspects of clinical safety is designed for everyone involved in clinical research activities.
This course provides key definitions based on the new European Community legislation as well as on consensus forums such as ICH and the CIOMS Working Groups. Practical examples and workshops are intended to illustrate these definitions and introduce the skills needed to perform clinical safety tasks successfully.
This foundational one day course on the essential aspects of clinical safety is designed for everyone involved in clinical research activities.
This course provides key definitions based on the new European Community legislation as well as on consensus forums such as ICH and the CIOMS Working Groups. Practical examples and workshops are intended to illustrate these definitions and introduce the skills needed to perform clinical safety tasks successfully.
Learning objectives, training objectives
Identify key definitions and vocabulary used in clinical safety in the EU. Recognise important aspects in evaluating adverse events. Identify main characteristics of adverse events, etc.
Identify key definitions and vocabulary used in clinical safety in the EU. Recognise important aspects in evaluating adverse events. Identify main characteristics of adverse events, etc.
Target Audience
Project Managers, CRAs & CTAs responsible for clinical operations, drug safety personnel, investigators, representatives of organisations including academia running clinical trials and medical managers from the pharmaceutical industry.
Project Managers, CRAs & CTAs responsible for clinical operations, drug safety personnel, investigators, representatives of organisations including academia running clinical trials and medical managers from the pharmaceutical industry.
Typical postgraduate careers and job opportunities
CRA, Clinical Research Associate, PM, Project Manager, Regulatory, Pharmacovigilance
CRA, Clinical Research Associate, PM, Project Manager, Regulatory, Pharmacovigilance
Certifications
ISO9001:2008
ISO9001:2008
Local Organizer
ECCRT
ECCRT
Enquiries and Registration:
Ms. Sunita Kelecom
Clinical Research
Languages
English
English
Fees
EUR 1.000,00
EUR 1.000,00
Organizer contact info
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
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