Pharmaceutical Communiqué: October - 2009

What Are the Key Compliance Learning Issues in 2009?

We reviewed ComplianceWire usage trends a few months ago to understand where clients focused their attention during the first half of 2009. We invite you to download the results in our 2009 Mid-Year Benchmarking Study.

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New ICH Courses Focus on Q2, Q8, Q9 and Q10

For those professionals in Quality and Regulatory Affairs seeking a detailed overview of the latest International Conference on Harmonization regulations, Kaplan EduNeering, in partnership with leading consulting firm EduQuest, will be unveiling the following new ICH courses:

  • ICH Q2: Validation of Analytical Procedures
  • ICH Q8: Documenting the Drug Development Process
  • ICH Q9: Quality Risk Management
  • ICH Q10: Pharmaceutical Quality System

These new courses complement the existing ICH Q7 (API) course, which is available to existing GMP Library subscribers.

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Using the Web to Improve Clinical Site Training

At the recent Regulatory Affairs Professional Society (RAPS) Annual Conference in Philadelphia, one valuable clinical track session, "Top 10 Mistakes Sponsors Make in Clinical Trials," focused on the  top 10 pitfalls that sponsors encounter during clinical trials. Number four was "Poor Training," and the presenters recommended several best practices for better training practices, including:

  • "Invest in the initial training upfront"
  • "Train your entire study team, whatever your system delivery is"
  • "Separate your investigator training from your coordinator training"
  • "Communicate inclusion/exclusion criteria"
  • "Structure multiple training periods: breakout the active enrollment period from followup period"
  • "Train the study teams and the backup centers at Investigator or kick-off meetings"
  • "Allow for site personnel turnover, and train the backups"

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