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International Pharmaceutical Aerosol Consortium on Regulation & Science

The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is an international non-profit association comprised on companies that develop, manufacture, market, and support research and development of inhaled and nasal drugs and biologics (INDBs). IPAC-RS seeks to advance the science, and especially the regulatory science, of these products by collecting and analyzing data, conducting joint research and development projects, and engaging the wider community.  Representing this industry sector for more than 25 years, IPAC-RS aims to build consensus and contribute to effective regulations and standards by sharing the results of its research through conferences, technical journals, webinars, and discussions with regulatory bodies.
IPAC-RS Nasal Innovation Forum
Advancing Science, Shaping the Future of Nasal Drug Delivery
Save the Dates!

Thursday - Friday, September 18-19, 2025 

In-Person Event

West Trenton, New Jersey

Join the IPAC-RS Nasal Innovation Forum on September 18th-19th for a 1.5-day in-person event that will bring together industry leaders, regulatory experts, and scientific pioneers to explore the complexities of nasal drug development. This forum provides a unique opportunity to engage in thought-provoking discussions, gain insights from expert speakers, and participate in collaborative roundtable sessions.

Visit the Forum webpage for more details.  Registration to open in May 2025.

IPAC-RS Roundtable Webinar Series 2025
 

In 2021, IPAC-RS launched a webinar series presented by SMEs in the pharmaceutical sciences, which enabled attendees the opportunity to learn about the latest research and regulatory trends.  See the IPAC-RS Roundtables webpage for links to presentations and recordings for the webinars held in 2021 - 2024. 

 

IPAC-RS continues its Roundtable series in 2025.  The first webinar of 2025, Designing for a Sustainable Future:  Strategies to Address the Device and Delivery System Lifecyle was on April 1 2025.  Visit the Roundtables webpage for information and to view the recording.  

IPAC-RS Workshop:  
Inhaled Biologics: Preparing for a Future Beyond Small Molecules

This hybrid event brought together industry experts to discuss the key challenges facing developers of inhaled and nasal biologics.

Presentations and recordings are now available on the workshop webpage.  

IPAC-RS representatives contributed to the planning of and presented at the CRCG Workshop:  Navigating the Transition to Low Global Warming Potential Propellants to be held on  December 4-5, 2024.

Ann Purrington (Kindeva) presented An Introduction to the IPAC-RS Scenarios - Transition to LGWP Propellants in MDIs: Proposed Pathways to U.S. FDA Approval and Richard Lostritto, Ph.D. (Consultant/IPAC-RS Science Advisor) and Helen Strickland (GSK) presented on Statistical Considerations for the In Vitro Comparisons of Critical Product Performance Attributes for an Approved MDI Product Transitioning to LGWP Propellant.

 

Podium presentations and recordings are now available at the weblink above. 

IPAC-RS Workshop on the Transition to Low Global Warming Potential Propellants for Metered Dose Inhalers

This workshop organized by IPAC-RS discussed the regulatory and technical aspects of the ongoing transition to low global warming potential (GWP) propellants in metered dose inhalers (MDIs).  

Check out the workshop website for the recording, a PDF of the presentations, a summary of the questions asked during the workshop and a summary of the presentations. 

News and Events

March 2025

We encourage you to take a look at the
IPAC-RS 2024 Year in Review!  
The report highlights the impressive work IPAC-RS accomplished in 2024.  
 

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January 2025

IPAC-RS is proud to announce the release of its 2025-2027 Strategic Plan. Please visit the Plan webpage for more details.  
 

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November 2024

IPAC-RS Scenarios - Transition to Low Global Warming Potential Propellants in Metered Dose Inhalers:  Proposed Pathways to US FDA Approval

IPAC-RS is pleased to share the above document, which was discussed at the CRCG Workshop in December 2024.  Ann Purrington (Kindeva) presented an introduction to the document at the workshop.

 

This document presents several regulatory scenarios to stimulate robust discussions of regulatory options for submitting technical information related to metered dose inhaler (MDI) propellants transitioning to Low Global Warming Potential (LGWP) propellants. Presented in this paper are three scenarios for regulatory pathways to address MDI products utilizing LGWP propellants.    

November 2024
 

The IPAC-RS Materials Working Group just released the updated Recommended Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP).  This document describes baseline requirements for materials used to manufacture components for OINDP, and is the second revision of the original document presented in 2011.   The first revision was issued in 2017.  This current revision is primarily driven by changes in the regulatory and standards landscape since 2017. 

 


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