ACDM Webinar - Recent Developments in GCP & Regulations From a Data Management Perspective
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?
Did you know that regulatory inspectors will be looking for evidence that you have received updated GCP & Regulations training every 2 years? This webinar will provide you with 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. The training course is updated annually so that you can be sure you have the most up to date information.
This webinar is for anyone working in data management on clinical trials. Why not gather a group together to ensure your team is up to date!
• 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
Date: 28 July 2016
Time: 12:00 – 13:30 GMT
Duration: 90 minutes
Instructor: Jon Wood
Jon Wood has a degree in physiology and brings nearly 25 years of industry experience across project management, biometrics and strategic sourcing roles within blue chip pharma and Contract Research Organisations.
Click here for more details and online booking
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