In Apr-13, the Medicines and Healthcare products Regulatory Agency (MHRA) successfully prosecuted an individual for manipulating pre-clinical analytical data. Following identification of irregularities in the bioanalytical data, the MHRA was notified and the following...
The Guideline for Good Clinical Practice (GCP) E6(R1) has been undergoing revision since Jun-15 and the revised guidance, the Integrated addendum E6(R2) (‘the addendum’) is planned for finalization soon. While the addendum includes few additions to investigator...