Critical Compliance and Major Changes for the EU Clinical Trials Directive (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Oct 19, 2011||End Date/Time: Oct 19, 2011|
This presentation will also discuss in what ways the Clinical Trials Directive is currently undergoing a major consultation process to try to overcome some of the key challenges of working to the Directive.
Areas Covered in the Seminar:
- What are the requirements of the Clinical Trial Directive for setting up and running clinical trials?
- Understanding the framework of key guidelines and documents which cover the detail of the Clinical Trials Directive requirements.
- What are the challenges and issues of working to the Directive and what are the options being considered to overcome these issues?
- What is the likely response to the 2011 consultation process to manage the problem areas of the Directive?
- What are the options being considered for improving clinical trial application authorization?
- What are the implications for inspection?