ACDM - Recent Developments in GCP & Regulations

Course overview
This webinar provides an insight into how current regulations and guidelines need to be applied in the data management arena in order to ensure effective compliance with relevant laws.

Who should attend?
All data management professionals working on clinical trials.

Content
• History behind the development of the regulations for trials involving human subjects
• Application of:
 -  ICH GCP
 -  Good Clinical Guidelines (E6)
 -  Directive 2001/20/EC
• Implementation of GCP in the conduct of clinical trials on Medicinal Products for Human Use
• Directive 2005/28/EC
• UK Statutory Instrument
• The Medicines for Human Use (Clinical Trials) Regulations 2004, and its amendment dated 2006
• Directive 95/46/EC
• Processing personal data and how to address privacy requirements
• The Data Protection Act 1998
 -  2001/20/EC Article 3, 2(c)
 -  What is personal data and how to address privacy requirements as a Data Manager
• How to prepare for an MHRA/FDA inspection
• HIPPA (privacy in US)
• 21CFR part 11
• Safety Reporting
• Protocol Deviations

By the end of this course you will:
• Understand why regulations have developed as a reaction to historical events
• Have gained an overview of all the regulations relevant to clinical trials
• Know how relevant regulations need to be applied when managing clinical data
• Know how to operate within the law when processing personal data

This course will be held as a 'webinar' from 12:00 - 13:30 on Tuesday 7th December 2010.

Webinar participation is £300 plus VAT per location. There is no limit to the number of delegates participating from one location. However, all delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions.

Click here to view the terms and conditions.