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ICH E2B guideline is changing in the frame of ISO and HL7 collaboration and its approval is expected by mid 2011. The new guidelines ICH E2B (R3) together with the implementation guide are presented ...

In addition, ICH safety experts held a day-long brainstorming session to discuss how to fill current gaps in safety guidelines. The next ICH Steering Committee will be held in Europe in June 2010. The ...

"The new guidelines represent an important step forward in protecting the safety, rights ... and executive sponsor of TransCelerate's ICH E6(R3) initiative. "Innovation in clinical research ...

"We created Medidata Strategic Monitoring after carefully reviewing the regulatory position papers, ICH Guidelines and TransCelerate ... ensuring patient safety." Medidata Strategic Monitoring ...