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.
Please join us for a FREE Virtual Workshop!
IPAC-RS Workshop on the Transition to Low Global Warming Potential Propellants for Metered Dose Inhalers
Wednesday, October 11, 2023 at 10:00 am – 3:30 pm US ET (Virtual)
You can register now to attend, Registration here.
This workshop organized by the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS,) will discuss the regulatory and technical aspects of the ongoing transition to low global warming potential (GWP) propellants in metered dose inhalers (MDIs).
The workshop is open to the public and topics to be discussed will include:
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Regulatory considerations for products with new propellants (presented by several confirmed US FDA speakers)
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Clinical Studies, PK Studies, Quality and CMC, Generics, Research and Clinical Endpoints for Generics
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Context of transition, including perspectives on previous CFC to HFC transition and product development evolution
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Readout from the IPAC-RS/IPAC surveys on alternate propellants
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Materials aspects of the transition to alternative propellants
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Panel Q&A discussion with all speakers
Check back for updates on details and the draft program (to be available by mid-September).
IPAC-RS Roundtable Webinar Series 2023
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 and the 2 webinars held in 2022.
IPAC-RS is continuing its Roundtable series in 2023, 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.
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The first webinar of 2023, Advancing Sustainability of Device and Container Closure Systems (Part II) was held on Tuesday, February 7, 2023. Visit the Roundtable webpage for PDFs of presentation and link to recording.
Upcoming IPAC-RS Roundtable topics include:
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Advancing Sustainability of Device and Container Closure Systems (Part III)
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Sustainability - Alternate Propellants
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Advanced Data Analytics
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Regulatory Evolution
News and Events
August 2023
IPAC-RS Summary of Global Regulatory Developments 2022
IPAC-RS engages actively in reviewing and commenting on regulatory developments around the world, and works collaboratively with all stakeholders to improve science-based regulations affecting orally inhaled and intranasal pharmaceutical products. IPAC-RS prepared a summary of relevant global regulatory developments in 2022.
April 2023
IPAC-RS and ISAM are co-hosting an in-person workshop entitled “Addressing CMC Questions for Development of Inhaled/Intranasal Biologic Products” at the ISAM Congress on Saturday, August 26, 2023 in Saarbrücken, Germany. Come to learn about latest updates and join the discussion!
April 2023
We encourage you to take a look at the IPAC-RS 2022 Year in Review!
The report highlights the impressive work IPAC-RS accomplished in 2022.
