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PDA PAC iAMSM

PDA's Post Approval Change Innovation for Availability of Medicines Program (PAC iAM)

 

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:

  1. 1.

    Accelerate awareness of the current challenges of PACs and activate a dialog at a broader industry and regulatory scale to drive significant change.

  2. 2.

    Apply science and risk-based approaches to change management in order to expedite PACs and reduce global regulatory filing burden.

  3. 3.

    Demonstrate streamlined PAC processes to enable international regulatory convergence and mutual reliance for improved availability of medicines to patients.

 
 
PAC iAM

2017 PDA PAC iAM Workshop

Sep 13 - Sep 14, 2017

Renaissance Washington, DC Hotel - Washington, DC

More information coming soon.
 

PDA JOURNAL ARTICLES

 
PDA Points to Consider: Technical Product Lifecycle Management Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
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PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System (PQS) Effectiveness for Managing Post Approval Changes
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PDA LETTER VIDEO

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PAC iAM Technical Report Team

PDA LETTER ARTICLES

 
PDA Program to Address Post-Approval Hurdles: A Call to Action

The seamless delivery of high quality, effective and safe medicines to patients is the primary responsibility of every pharmaceutical company. Doing so, however, is by no means effortless.

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Drug Shortage is a "Wicked Problem"

Drug shortage is undeniably a big problem that impacts public health around the globe. Anyone involved in pharmaceutical manufacturing and its regulation knows that the problem is complex and has more than one root cause.

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PREVIOUS WORKSHOP PRESENTATIONS

 
Where is PDA playing an active role for ICH Q12?

Why PDA is involved and how we plan to help.

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Managing Post Approval Changes

What does it take to register an alternate site for the release and stability testing of a finished product? How a relatively simple change is handled in a highly complex global marketplace.

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