Senior Management Involvement is Critical for ICH Q8-10 Implementation Success, Regulators Affirm

Regulators from all three ICH regions participating in a Q8-10 training workshop in Estonia in early June stressed the need for pharma company senior management support to achieve the ICH quality system objectives – pointing to the improved quality, compliance, communication and relationships with regulators that result from this commitment.

During a panel discussion at the workshop, ICH Quality Implementation Working Group (IWG) Rapporteur Jean-Louis Robert (EDQM) asked the panelists, “if you had to sell the ICH principles to senior management in one slide, what would [you] highlight as the top five key benefits?”

Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment (ONDQA) Director Moheb Nasr pointed to better quality and compliance as topping the benefit list.  The ICH processes “provide manufacturing flexibility and that comes with a great opportunity as you continue to deal with shrinking markets and challenges in pharmaceutical development,” he stressed.

“I would like to add better communication between industry and regulators, which is a key issue,” said AFSSAPS Assistant Director Jacques Morénas.  “For me one of the top issues to raise to senior management is really facilitating communication between” regulators and industry, which among other benefits serves to reduce “the number of inspections or depth of inspections, or the length of inspections.”

[More of the discussion in Estonia on the importance of senior management in ICH Q8-10 implementation is available to subscribers here.]