A clinical research study sponsor plays a vital role in the drug development process – starting with preparing a complete Investigator’s Brochure, a safe study protocol, and providing effective data. Sponsors are also responsible for choosing sites and principal investigators (PI) who will conduct the study according to clinical research GCP and federal regulations. Additionally, they must monitor the study to ensure data validity and integrity, and correct reporting to the regulatory authorities.
GCP investigator site and sponsor audits are a routine and a necessary part of the clinical trial process. If you are a sponsor or are participating in a clinical trial or multiple trials as a PI, a study coordinator, a monitor, or even as the IRB, chances are that you may be audited.
This webinar by our expert speaker Charles Pierce, MD, Ph.D., FCP, CPI, will cover the most frequently found GCP violations / mistakes that are often found during the audit process. You also learn how to prevent audit finding that can land your organization in trouble. Charles will review FDA inspection program details and guide you to ensure your site is prepared for an inspection. You will understand the key components of a good audit program; get helpful hints to help you avoid the common GCP mistakes; and tips to enhance the overall audit experience.
Take a good step toward the challenge of learning the FDA processes and learn the importance of a knowledgeable sponsor and PI. Know the mandates for a sponsor, how they apply to an audit outcome, and how they relate to the PI’s responsibilities. Get a better understanding of sponsor responsibilities according to the ICH:
Who should attend?
This webinar will provide invaluable assistance to all personnel in the pharmaceutical, biotechnology, and CRO industry who may be called upon to conduct clinical trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance personnel. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA/QC auditors and staff, and Clinical Research Data managers.
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
Charles H. Pierce, MD, PhD, FCP, CPI
From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...
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