In our latest article, Larry Mager discusses the EU/US GMP Mutual Recognition Agreement (MRA) which will pave the way for exchanges of GMP inspection documents and usage of inspection.
Our latest blog summarizes two critical EU MDR presentations delivered at this year's MedCon conference, held at Xavier University in Cincinnati, OH from May 3 to May 5.
The team at Medicare Compliance Solutions discuss how Prescription Drug Event (PDE) records are the official records used by the Centers for Medicare & Medicaid Services (CMS) for Part D revenue reconciliation, coverage gap discount payments, STAR measures, 1/3 financial audits, and CMS program audits.
Our latest clinical blog discuss the requirements that clinical operations teams have shared with UL about their eClinical Qualification system needs. Sponsors are seeking assurances that clinical site personnel have received GCP education, that they can carry out the protocol properly, and that they can properly perform operational tasks, such as EDC entries.
In our latest learning article, Karl Kapp discusses the temendous value of an LMS and how reports of the death of the LMS are greatly exaggerated.