The FDA, MHRA, EMA and other regulatory agencies routinely perform both announced and unannounced on-site clinical investigator inspections to determine if clinical investigators are conducting studies in compliance with regulatory requirements. Clinical investigators are required to permit inspectors to access, copy, and verify any records or reports made by the investigator during the trial. The purpose of an inspection is to verify the accuracy and reliability of data that has been submitted to the agency, and to provide real-time assessment of the investigator’s conduct of the trial to ensure human safety. If a clinical site fails inspection, several penalties’ can occur and may eventually lead to millions of dollars of fines, disbarment of an investigator, and even criminal charges.
Preparing for a clinical inspection involves making sure that all aspects of your clinical trials are up to code. This includes being able to provide all required documents that prove that your trial is GCP compliant.
The 3rd Annual Clinical Trials Inspection Readiness Summit is designed to evaluate the necessary steps that sponsoring companies must take in order to ensure that their clinical investigator sites remain compliant before and during an agency inspection to avoid serious fine and penalties. In addition, the importance of conducting internal audits and opening up the lines of communication between the investigators and the sponsoring company will also be explored, both locally and globally.
“A lot of learning based on presenter and peer experience…” – Lead Advisor, ASTRAZENECA
“Great-speakers were excellent!” – Director Clinops, TARSA
“Information was very well presented and valuable” – Sr. training Specialist, JANSSEN
“…presentations were relevant and sufficiently detail appropriate for an experienced audience” – Deputy Director, SANOFI
“This has been the best conference I have ever attended. The speakers have all been great and the use of humor in several presentations is a welcome relief to information that is often tedious.” – CCRP, MAYO CLINIC
“Very effective, well delineated” – VP BD, PHLEXGLOBAL
“Perfect size, good location, good content” – Principal, ALPHA PRIME CONSULTING
C-Level, Vice President, Director, and Manager level executives from pharmaceutical, biotech, medical device companies, and CROs in the following areas:
This conference is also relevant to clinical QA/compliance professionals involved with: