Critical Compliance and Major Changes for the EU Clinical Trials Directive (Clinical Compliance )

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Oct 19, 2011 End Date/Time: Oct 19, 2011
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Description

This presentation will explain the framework of documents, provided in the Clinical Trials Directive, which sets out how clinical trials must be conducted. We will discuss how the Directive was further expanded by Commission Directive 2005/28/EC of laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice - " the GCP Directive").

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?

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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