Transforming Clinical Quality through a Compliant & Robust Risk-Based Approach
In November 2016, ICH published an addendum to its guidelines for clinical practice, prompting pharmaceutical companies to align current clinical quality procedures with a risk-based monitoring approach. What was previously a recommendation by ICH to have a robust quality management program for clinical trials is now a requirement to ensure clinical quality and data integrity. The updated ICH guideline along with FDA’s continued scrutiny of clinical research operations has brought clinical quality assurance back to the center of importance and discussion throughout the pharmaceutical industry. Q1 Productions’ Clinical Quality Compliance and Risk Management Conference will bring together clinical quality executives from a variety of pharmaceutical companies to share valuable insights on the implementation of risk-based monitoring while also addressing innovative approaches for tackling ongoing challenges in clinical quality.
Through a series of case studies, panels and interactive group discussions, attendees will have the opportunity to hear a variety of perspectives including FDA, clinical research organizations, pharmaceutical companies and regulatory experts. Conference topics will address the most pressing questions that clinical quality executives have, from clinical site monitoring strategies to conducting robust root cause investigations for clinical CAPAs. The Clinical Quality Compliance and Risk Management Conference is a must-attend event for pharmaceutical GCP quality teams, as it will offer conference participants an invaluable experience and networking opportunity with practical take-aways that can be implemented immediately.
Lydia Welmer | Marketing Coordinator | Q1 Productions
312.955.0897 | firstname.lastname@example.org