ABOUT PAC iAMSM
The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product-related post-approval changes (PACs). The cGMPs require facilities and processes to be current, yet even for simple PACs it takes up to five years to get global approval for what will make the facility or process current.
PDA’s PAC iAM (Post Approval Change: Innovation for Availability of Medicines) program strives to identify, assess and address current barriers to implementation of post approval changes that are intended to ensure continued operations, drive innovation and continual improvement. Addressing these barriers will better ensure and sustain reliable global supply and availability of product to patients through the entire commercial lifecycle of a product.
PDA’s efforts are intended to call the industry to action to:
Accelerate awareness of the current challenges of PACs and activate a dialog at a broader industry and regulatory scale to drive significant change.
Apply science and risk-based approaches to change management in order to expedite PACs and reduce global regulatory filing burden.
Demonstrate streamlined PAC processes to enable international regulatory convergence and mutual reliance for improved availability of medicines to patients.
2017 PDA PAC iAM Workshop
Sep 13 - Sep 14, 2017
Renaissance Washington, DC Hotel - Washington, DC
More information coming soon.