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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.

 
PAC iAM

2017 PDA PAC iAM Workshop

Sep 13 - Sep 14, 2017

Renaissance Washington, DC Hotel - Washington, DC

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Post‐approval Change and Knowledge Management –Where are We? Results from the PAC iAM Task Force Survey

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PAC iAM TF Chair Anders Vinther discusses the role of PACs and regulatory complexity in drug shortages

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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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A Roadmap to Avoid Drug Shortages

Only by encouraging and adopting innovative manufacturing practices can an uninterrupted supply of drug product possibly exist. What is holding us back from innovating?

 
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PDA Supports Efforts to Encourage Manufacturing Innovation

Barriers to innovation during lifecycle management of a product are multiple. Recognizing the need for action, several international organizations are currently working toward the global convergence of regulatory requirements for PACs.

 
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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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The Future State

Knowledge Management and Sharing to Reduce Regulatory Burden.

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