Training Courses & Events from the ACDM

A wide variety of training courses and events for members of the ACDM and non-members

Regulatory Guidelines Refresh for Data Managers

Course Date: May 23, 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 GMT
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

 

Price (Member)  £175 for 1 – 15 delegates £275 for 16 – 50 delegates per location (+VAT)
Price (Non-Member)  £275 for 1 – 15 delegates £375 for 16 – 50 delegates per location (+VAT)
Link for Booking:  click here

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