Risk-based Quality Management (RBQM) Video Series – Part 3
Taren Grom, Editor, PharmaVOICE (Moderator)
Amy Kissam-Sands, Senior Vice President, Clinical Operations, Parexel
Tim Audin, Senior Director, Risk Management (IRMCert) Parexel
ICH Q9 (1) focuses on Quality Risk Management.
The Q9 concept paper, endorsed in November 2020, states that the benefits of Quality Risk Management have not yet been fully realized. Four subject areas are under scrutiny, and revisions may influence how we apply and perform risk management in clinical trials in accordance with E8 (R1) Sections 3.2 and 3.3. Among these, the most relevant to clinical trial design and conduct will be considerations of: the subjectivity of risk assessment (scoring); the level of formality required to perform risk management; and what good risk-based decision-making actually looks like. Wording in the Q9 concept paper suggests an emphasis on the manufacturing side of clinical development. But it is worth noting that the guideline applies to all aspects of clinical trials and will offer important considerations that complement content in ICH Q10 Pharmaceutical Quality System.