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Ramada Apollo Amsterdam Centre

Wednesday 18th September 2019, 9:00am

Price: £2,496.00
(£2,596.04 including booking fee)

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About Clinical Trial Regulations With ICH GCP E6 R2 Workshop

Clinical Trials Event Date 17 – 19 September, Location – Amsterdam, The Netherland


Complexity and cost of clinical trials have increased dramatically in recent years. Learn how evolutions in technology and risk management process offer new opportunities to increase efficiency and focus on relevant activities and clinical trial protocols.


  • Risk assessment
  • Risk management
  • Risk-based monitoring
  • Central monitoring
  • Safety reporting
  • Computerized systems
  • Training on Validation of computerized systems
  • IMP handling according to GCP training
  • EU Annex 13
  • Sponsor & investigator oversight training
  • Training to discover important developments such as Riskbased approaches to trial management & oversight.
  • Training to develop GCP problem solving skills by considering the most common problems encountered in clinical trials.
  • Have a complete understanding of different processes in a clinical trial
  • Explore the most important rules related to handling of clinical trial data.
  • Training to understand  trial master file requirements

KEY BENEFITS (Clinical Research Associate Training)

  • Learn the practical implications and phases of clinical trials of the new regulatory requirements for clinical trials, including ICH E6(R2) and the EU Clinical Trials Regulation in this training
  • Be able to implement more efficient, risk proportionate approaches for clinical trial application while continuing to ensure human subject protection and data integrity in this training
  • Learn to analyze risks in clinical trials and implement risk mitigation plans including monitoring plans in this training
  • Demonstrate sponsor oversight in line with regulatory requirements and Regulatory Agency expectations in this training

Ramada Apollo Amsterdam Centre

Amsterdam, The Netherland,
1008 dg


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