Following the JCP Nov 2011 publication proposing food as a viable means for demonstrating assay sensitivity for ECG assessment in clinical trials, this is now proposed alongside other potential methods at the upcoming CSRC ThinkTank meeting on QT Assessment in Early Clinical Development being held 2 Feb at the FDA Headquarters in Silver Spring.The purpose of these meetings is the formation of collaborative CSRC research groups with members from regulators, sponsors and academia with the goal to perform, promote and compile research in areas addressing identified key knowledge gaps.

Latest news

Futureproofing early phase clinical research for the next generation of investigators.

March 20, 2023
Richmond Pharmacology’s experienced Principal investigators and Co-investigators recently gave expert feedback on the ICH M11 (CeSHarP) protocol template.
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Director of Operations, Keith Berelowitz, has been appointed as the Research Ethics Committee Chair for the Health Research Authority.

January 19, 2023
Keith Berelowitz will be responsible for ensuring that all ethical possibilities are explored in relation to new research.
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Events

13th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions

Sunday, June 4th to Tuesday June 6th 2023
Exchange research-based knowledge on drug-drug interactions (DDIs) among all interested stakeholders from pharmaceutical industry, regulatory authorities, academic and health care delivery backgrounds and perspectives.
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