This 2-day practical course will take delegates through the essential regulatory requirements for clinical research in Europe and wll also include key US requirements which impact on trials in Europe.
The most important areas of regulations and guidelines controlling clinical trials will be covered including: understanding the importance of the EU Clinical Trial Directive; clinical trial authorisations; the increasingly important requirements for running trials in children; requirements for managing investigational medicinal product; legal aspects of clinical trials; pharmacovigilance; data management, GCP requirements; regulatory inspection and more. Topics will also include an update on the latest CT Directive guidelines and other EU Clinical Trial developments.
The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.
The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials.
"Lots of information provided- very good"
"Very good course and speaker"
"Good course!"
Follow PTI on twitter:
@PTI_Courses

Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals