International Pharmaceutical Aerosol Consortium on Regulation & Science
The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is an international association that seeks to advance the science, and especially the regulatory science, of orally inhaled and nasal drug products (OINDPs) by collecting and analyzing data, and conducting joint research and development projects. Representing the OINDP industry since 2000, 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 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 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.
January 2025
IPAC-RS is proud to announce the release of its 2025-2027 Strategic Plan. Please visit the Plan webpage for more details.
November 2024
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.
