Training Course & Event Calendar
Regulatory Guidelines Refresh for Data Managers
Course Date: June 15, 2018
Type of Course: Webinar
Course Trainer: Mark Elsley – Mark is a highly experienced professional in clinical data management and has over 25 years experience working for major pharmaceutical companies, academic institutions and CROs. He has lectured extensively on clinical data management and has recently authored ‘A Guide to GCP for Clinical Data Management’
Location of Course: 12:00 BST
Learning Objectives:
Who is the Course Suitable For?
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!
This webinar is aimed at Data Managers, Project Managers, Clinical Research Associates, Drug Safety specialists and Quality Assurance personne
Outline Course 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/E• 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
Link for Booking: click here