Risk-based Quality Management (RBQM) Video Series – Part 2
Taren Grom, Editor, PharmaVOICE (Moderator)
Amy Kissam-Sands, Senior Vice President, Clinical Operations, Parexel
Tim Audin, Senior Director, Risk Management (IRMCert) Parexel
Patient safety is again the primary concern of E6, but Revision 3 further directs sponsors to include patients in the research process. Inclusion of patient insights is expected on issues that may range from burdens in study participation to meaningful trial endpoints. Sponsors must actively engage with patients and patient organizations and incorporate their views in both clinical trial design and conduct.
The E6 (R3) concept document further prepares industry to overcome the inflexibilities of our current operating environment by addressing broad issues related to the adaptability of trial design and conduct; Annex 1 and Annex 2 outline regulatory views
The existing 13 principles of E6 (R2) have been incorporated into a revised set of 11 principles in E6 (R3) and are publicly available for review. The Expert Working Group advises that industry begin working now to implement them.