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 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. In-person breakout sessions will focus on three major areas: (A) Formulation Approaches, Delivery Technologies and Manufacturing of Biologic Products; (B) Analytical Testing & Control Strategies; (C) Safety Considerations & Toxicological Testing.
IPAC-RS representatives are contributing to the planning of and will be presenting at the CRCG Workshop: Navigating the Transition to Low Global Warming Potential Propellants to be held on December 4-5, 2024.
Ann Purrington (Kindeva) will present 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) will present on Statistical Considerations for the In Vitro Comparisons of Critical Product Performance Attributes for an Approved MDI Product Transitioning to LGWP Propellant.
Visit the Workshop link above for details. Registration is now open. For in-person attendance, registration closes on November 25th.
Podium presentations will be recorded, but small-group discussions will not. Virtual attendees will have access only to podium talks but not small-group discussions
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.
IPAC-RS Roundtable Webinar Series 2024
In 2021, IPAC-RS launched a new webinar series. Presented by SMEs in the pharmaceutical sciences, this opportunity enabled attendees to learn about the latest research and regulatory trends. See the IPAC-RS Roundtables webpage for links to presentations and recordings for the 5 webinars held in 2021, 2 webinars held in 2022, and 1 webinar held in 2023.
IPAC-RS continues its Roundtable series into 2024, supplementing the podium presentations held at the IPAC-RS/RDD Joint session that addressed Regulatory, Science and Technology Innovations Enabling Novel and Improved OINDP Design, Development and Manufacturing. The first webinar of 2024, Regulatory and Technical Considerations in Sustainable Lifecyle Approaches for OINDP Device and Container Closure Systems (Part III) was held on March 14, 2024. Visit the Roundtable webpage to view the recording and presentation slides.
Upcoming IPAC-RS Roundtable topics include:
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Sustainability - Alternate Propellants
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Advanced Data Analytics
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Regulatory Evolution
News and Events
November 2024
IPAC-RS is pleased to share the above document, which will be discussed at the CRCG Workshop in December 2024. Ann Purrington (Kindeva) will present 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.
April 2024
We encourage you to take a look at the IPAC-RS 2023 Year in Review!
The report highlights the impressive work IPAC-RS accomplished in 2023.
