ICH E6 R3 (GCP) Regulatory Inspections: What Changes to Expect

Course Description ICH GCP was introduced 30 years ago, but the GCP renovation, which was announced in January 2017, brought about a rewrite and reorganization as well as the introduction of new concepts to clinical research. Major conceptual changes go hand in hand with minor changes that enable a streamlining of the clinical trial process. This course examines the changes to regulatory inspections and their focus resulting from the adoption of ICH E6 (R3). Participants will gain insight into how inspectors are expected to evaluate risk-based quality management systems, oversight of critical processes, and the use of technology in modern clinical trials. Emphasis will also be placed on practical strategies for ensuring inspection readiness and maintaining compliance with evolving expectations around documentation, data integrity, and sponsor-investigator responsibilities. Learning Objectives Understand new expectations resulting from the ICH E6 (R3) changes Understand the differences between the main regulatory authorities' Inspection methods/philosophy Understand the impact on regulatory inspections, in particular how inspectors will evaluate RBQM systems and sponsor oversight Examples of the changes in inspections Describe practical strategies for ensuring inspection readiness Who Should Attend Quality Management Pharmacovigilance Management (Medical, Clinical Operations, Onsite operations, DM and Statistics) Instructor William Andrew Lawton Click here for complete trainer biographies Fee $835 *Includes up to 20 participants at one site. All participants (up to 20) are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, call +1 215.413.2471 or toll-free in the U.S. 800.856.2556 for pricing. AccreditationBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.0 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.ACPE#: 0778-0000-26-001-L99-P Released: 5/26. Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.