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ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface
Session Chair(s)
Anna Adams, PhD, MSc
Senior GPvP Inspector, Inspection, Enforcement and Standards
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
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 Objective : Learn about system vulnerabilities where Good Clinical Practice (GCP) and pharmacovigilance (PV) interface Understand better the regulatory requirements for the PSMF that require clinical input and should lead to. Discover the rationale for using the PSMF as a tool for closer system integration. Examine the practical relationships and interfaces between and GCP and PV
Speaker(s)
The Need to Focus on the GCP/PV Interface to Improve Compliance, Data Integrity, and Confidence in Inspection Readiness
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
Precision Global Safety Reporting in Clinical Trials According to Local Rules and Industry Standards
Steven Beales
WIRB-Copernicus Group (WCG), United States
Senior Vice President, Scientific and Regulatory Review
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