There has been increasing recognition of the limitations of the GCP guidelines, and the context of these potential limitations and potential remedies will be explored. This workshop series is free and ...

DUBLIN--(BUSINESS WIRE)--The "The New ICH GCP E6 R2 Guideline" conference has been added to Research and Markets' offering With the new ICH GCP E6 Revision 2 changes now finalised and needing to ...

Good Clinical Practice (GCP), the bedrock of ethical and ... of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the ICH E6(R3) draft guideline for public consultation ...

May still be relevant for non-marketing authorization trials (consult the guideline for details). Until then, ICH E6 (R2) remains the live, valid and applicable GCP guideline for quality-focused ...

FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of ...

As new ICH GCP draft guidelines now require root cause analysis, novel methods for risk analysis and triage must be adopted in drug development. Decades ago, a study would typically be performed by a ...

DIA attendees are encouraged to visit CROS NT at DIA Booth #1040 to learn more about how CROScheck addresses the challenges that Sponsors encounter within the new GCP E6(R2) Guidelines that have ...

TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today covers six focus areas: risk ...

I am responsible for conducting phase I-IV industry sponsored clinical trials for urologic oncology and urological disorders/diseases in accordance with standard operating procedures, federal ...

There has been increasing recognition of the limitations of the GCP guidelines, and the context of these potential limitations and potential remedies will be explored. Contact [email protected] or ...