DIA 2020 Virtual Global Annual Meeting

Component Type: Session
Level: Intermediate

Safety for subjects participating in clinical trials is paramount. Regulatory reporting requirements that are in place around the world facilitate the timely notification of regulatory authorities, sponsors, investigators and ethics committees to ensure that that emerging risks are identified swiftly and that trial subjects are protected. Once a product is granted authorization, pharmacovigilance requirements apply to ensure patients are protected and, if interventional studies are ongoing, clinical trials requirements continue to apply to ensure protection for trial subjects. This session will look at novel approaches to efficiently fulfilling safety reporting requirements for clinical trials. The session will also examine the interfaces between pharmacovigilance and clinical trials, and how strong relationships between pharmacovigilance and clinical functions can achieve a more proactive approach to protecting both patients and trial subjects.

Learning Objectives

Describe the interfaces between pharmacovigilance and GCP; Identify tools for building practical relationships between pharmacovigilance and GCP to better protect patients and trial subjects; Recognize effective processes for ensuring timely safety reporting to regulatory authorities and other concerned stakeholders to ensure trial subjects are protected in real-time.

Chair

Anna Adams, PhD, MSc

Speaker

The Need to Focus on the GCP/PV Interface to Improve Compliance, Data Integrity, and Confidence in Inspection Readiness
Shelley Gandhi, MSc

Precision Global Safety Reporting in Clinical Trials According to Local Rules and Industry Standards
Steven Beales