Industry One-Voice-of-Quality (1VQ)
on Post Approval Changes (PACs)

Ideally:
One product for one world

Reality:
One product with 100+ approvals

Closer to real-time post-approval change management

to reduce drug shortages and enhance continual improvement and innovation

Post-approval changes are inevitable and necessary throughout the life of a drug product – to implement new knowledge, maintain a state of control, and drive continual improvement.

Due to the global complexity, individual PACs often take years for full worldwide approval, even when they reduce patient risk, improve compliance, and/or enhance processes or methods. This can ultimately lead to potential drug shortages for patients and possible compliance risks for companies.

Chief Quality Officers of 20+ global pharmaceutical companies are speaking with “One-Voice-Of-Quality” to offer solutions that will greatly reduce PAC complexity with no added risk to patient safety.

 

1VQ Objective

Identify, assess and address current barriers to implementation of post approval changes that are intended to ensure continued (un-interrupted) operations, drive innovation and continual improvement in a maximally efficient, agile, flexible Pharmaceutical manufacturing sector.

Addressing these barriers will better ensure and sustain reliable global supply and availability of high-quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.

We invite you to join the dialog, share your thoughts, successes or suggest PAC examples
to align the industry on, at 1VQ@prst.ie

Emma Ramnarine

1VQ Co-Lead
Global Head, External Development Collaborations
Genentech/Roche

Email:  1VQ@prst.ie

Anders Vinther

1VQ Co-Lead
VP, Global Head Technical Operations
Intarcia Therapeutics

Email:  1VQ@prst.ie